|
ADASUV |
inhalation powder, metered, 9,1 mg/dose, 1 foil pouch with 1 Staccato® inhaler No. 1 in a cardboard pack |
Ferrer Internacional, S.A. |
Spain |
Alexza Pharmaceuticals, Inc., USA (manufacture and primary packaging); Ferrer Internacional, S.A., Spain (secondary packaging, quality control and batch release) |
USA/ Spain |
amendments to registration materials:
correction of a technical error in the quality control methods in the release and shelf-life specification in the section “Assay” |
By prescription |
UA/16580/01/01 |
|
ADEMPAS® |
film-coated tablets, 2,5 mg No. 42: 21 tablet per blister; 2 blisters in a carton box; No. 84: 21 tablet per blister; 4 blisters in a carton box |
Bayer AG |
Germany |
Bayer AG, Germany (all stages of manufacture); Stegemann Lonferpakung & Logistischer Service e.K., Germany (secondary packaging) |
Germany |
amendments to registration materials: Type I variations – introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of contact details of the qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14101/01/01 |
|
ADEMPAS® |
film-coated tablets, 2,0 mg No. 42: 21 tablet per blister; 2 blisters in a carton box; No. 84: 21 tablet per blister; 4 blisters in a carton box |
Bayer AG |
Germany |
Bayer AG, Germany (all stages of manufacture); Stegemann Lonferpakung & Logistischer Service e.K., Germany (secondary packaging) |
Germany |
amendments to registration materials: Type I variations – introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of contact details of the qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14101/01/02 |
|
ADEMPAS® |
film-coated tablets, 1,0 mg No. 42: 21 tablet per blister; 2 blisters in a carton box; No. 84: 21 tablet per blister; 4 blisters in a carton box |
Bayer AG |
Germany |
Bayer AG, Germany (all stages of manufacture); Stegemann Lonferpakung & Logistischer Service e.K., Germany (secondary packaging) |
Germany |
amendments to registration materials: Type I variations – introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of contact details of the qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14101/01/03 |
|
ADEMPAS® |
film-coated tablets, 1,5 mg No. 42: 21 tablet per blister; 2 blisters in a carton box; No. 84: 21 tablet per blister; 4 blisters in a carton box |
Bayer AG |
Germany |
Bayer AG, Germany (all stages of manufacture); Stegemann Lonferpakung & Logistischer Service e.K., Germany (secondary packaging) |
Germany |
amendments to registration materials: Type I variations – introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of contact details of the qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14101/01/04 |
|
ADEMPAS® |
film-coated tablets, 0,5 mg No. 42: 21 tablet per blister; 2 blisters in a carton box; No. 84: 21 tablet per blister; 4 blisters in a carton box |
Bayer AG |
Germany |
Bayer AG, Germany (all stages of manufacture); Stegemann Lonferpakung & Logistischer Service e.K., Germany (secondary packaging) |
Germany |
amendments to registration materials: Type I variations – introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of contact details of the qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14101/01/05 |
|
AZAGILIN® |
tablets of 1 mg, 10 tablets per blister; 3 blisters per cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
batch control (physicochemical) and batch release:
Galenicum Health, S.L., Spain;
batch control (microbiological control):
Eurofins Biopharma Product Testing Spain, S.L.U., Spain;
manufacturing, packaging, batch control and batch release:
J. Uriach y Compañía, S.A., Spain |
Spain |
amendments to registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460). Change of applicant for a finished medicinal product due to the transfer of ownership rights and the marketing decision of the current and new applicant companies. |
by prescription |
UA/17013/01/01 |
|
AZITHRO SANDOZ® |
film-coated tablets, 250 mg each, 6 tablets per blister, 1 blister per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
S.C. Sandoz S.R.L., Romania (full-cycle manufacture); Salutas Pharma GmbH, Germany (primary and secondary packaging, batch control, batch release authorization); Sandoz Ilac Sanayi ve Ticaret A.S., Turkey (manufacture of bulk product) |
Romania/Germany/Turkey |
amendments to registration materials:
Type I variation – deletion of one of the approved manufacturers of the API azithromycin dihydrate |
by prescription |
UA/11332/01/01 |
|
AZITHRO SANDOZ® |
film-coated tablets, 500 mg each, 3 or 6 tablets per blister, 1 blister in a box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
S.C. Sandoz S.R.L., Romania (full-cycle manufacture); Salutas Pharma GmbH, Germany (primary and secondary packaging, batch control, batch release authorization); Sandoz Ilac Sanayi ve Ticaret A.S., Turkey (manufacture of bulk product) |
Romania/Germany/Turkey |
amendments to registration materials:
Type I variation – deletion of one of the approved manufacturers of the API azithromycin dihydrate |
by prescription |
UA/11332/01/02 |
|
AZITHRO SANDOZ® |
powder for oral suspension, 100 mg/5 mL; 17,1 g of powder for 20 mL of oral suspension in a bottle; 1 bottle in a kit with an adapter and a dosing syringe in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
S.C. Sandoz S.R.L. |
Romania |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/4764/02/01 |
|
AZITHRO SANDOZ® |
powder for oral suspension, 200 mg/5 ml, 17,1 g of powder for 20 ml of oral suspension in a vial; 1 vial with an adapter and a dosing syringe in a carton box; 24,8 g of powder for 30 ml of oral suspension in a vial; 1 vial with an adapter and a dosing syringe in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
S.C. Sandoz S.R.L. |
Romania |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/4764/02/02 |
|
ALDARA |
cream 5%; 250 mg in a sachet; 12 sachets in a cardboard box |
MEDA AB |
Sweden |
3M Health Care Limited |
Great Britain |
amendments to the registration materials: Type I changes – tightening of the limits specified in the specification of the active substance Imiquimod for the sum of impurities from NMT 0, 50% w/w to NMT 0,20% w/w due to the update of the DMF of Teva Pharmaceutical Works Private Limited Company version 1030-EU-09.2015 to version 1030-EU-07.2017; editorial corrections to section 3.2.S.4.2; Type I changes – addition of an alternative test method ATR-IR for identification of the active substance Imiquimod due to the update of the DMF of Teva Pharmaceutical Works Private Limited Company version 1030-EU-09.2015 to version 1030-EU-07.2017, editorial corrections to section 3.2.S.4.2; Type I changes – addition of an alternative test method Coulometric water content determination for the active substance Imiquimod due to the update of the DMF of Teva Pharmaceutical Works Private Limited Company version 1030-EU-09.2015 to version 1030-EU-07.2017, editorial corrections to section 3.2.S.4.2; Type I changes – introduction of stricter conditions for the active substance Imiquimod from " In a tight container" to "Store at up to 25° C Avoid excessive heat. Keep in tight container". Editorial corrections were made to section 3.2.S.2.1,3.2.S.7.3. |
by
prescription |
UA/12999/01/01 |
|
ALLERGOMAX |
syrup, 0,5 mg/ml, 50 ml in a vial, 1 vial together with a dosing syringe-pipette in a cardboard box or
100 mL per bottle, 1 bottle together with a dosing syringe-pipette per cardboard box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
all stages of manufacturing, quality control, batch release:
Limited Liability Company “Pharmaceutical Company “Zdorovia”,
Ukraine
all stages of manufacture, quality control:
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu”,
Ukraine |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites. (activity for which the manufacturer/importer is responsible, not including batch release) – change of address of the manufacturer of the finished medicinal product, Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu”, Ukraine, without change of the manufacturing site |
without
prescription |
UA/10913/02/01 |
|
ALLERTEC® NASO |
nasal spray, metered-dose, suspension, 50 mcg/dose, 60 or 120 or 140 doses of suspension in a PET bottle with a metering pump spray; 1 bottle in a carton |
Medana Pharma Joint Stock Company |
Poland |
“Pharmea” |
France |
introduction of changes to registration materials: Type I variations – changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product – increase in the hold time of the mometasone furoate suspension from 96 hours to 13 days, during the manufacturing of the medicinal product |
by
prescription |
UA/14933/01/01 |
|
ALOTENDIN |
tablets, 10 mg/5 mg each, 7 tablets per blister; 4 or 8 blisters in a carton; 10 tablets per blister, 3 or 9 blisters in a carton |
CJSC Pharmaceutical Plant EGIS |
Hungary |
CJSC Pharmaceutical Plant EGIS |
Hungary |
amendments to registration materials: Type I variations – replacement of the source of an excipient or reagent that presents a risk of transmission of TSE agents (from a material presenting a risk of TSE transmission to a material of plant or synthetic origin) – For excipients or reagents that are not used in the manufacture of an active substance of biological/immunological origin, or a medicinal product of biological/immunological origin |
by
prescription |
UA/11609/01/04 |
|
AMBROXOL |
tablets of 0,03 g, 10 tablets per blister; 1 or 2 blisters per cardboard pack; 10 tablets per blister; 50 or 100 blisters per cardboard pack |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
amendments to registration materials: Type I variations – changes in the test methods of the finished medicinal product. Introduction of the possibility of using reference standards of leading pharmacopoeias and working reference standards of ambroxol hydrochloride for the parameters “Related substances”, “Dissolution”, “Assay”; Type II variations – change of periodic control for the parameter “Microbiological purity” from batch-by-batch to selective (the first and every fifth batch) |
without
prescription |
UA/6958/01/01 |
|
AMBROXOL |
tablets of 0,03 g in bulk: 3000 tablets in containers |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
amendments to registration materials: Type I variations – changes in the test methods of the finished medicinal product. Introduction of the possibility of using reference standards of leading pharmacopoeias and working reference standards of ambroxol hydrochloride for the parameters “Related substances”, “Dissolution”, “Assay”; Type II variations – change of periodic control for the parameter “Microbiological purity” from batch-by-batch to selective (the first and every fifth batch) |
– |
UA/2980/01/01 |
|
AMINOVEN INFANT 10% |
solution for infusion, 100 ml or 250 ml in vials |
Fresenius Kabi Deutschland GmbH |
Germany |
Fresenius Kabi Austria GmbH |
Austria |
amendments to registration materials:
Type I variations – deletion of a manufacturing site (including sites for the API, intermediate product or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient – deletion of the API manufacturer L-methionine Rexim, France; deletion of the API manufacturer L-serine Evonik Rexim S.A.S. France; deletion of the API manufacturer L-serine Kyowa Hakko Bio Co., Ltd., Japan; deletion of the API manufacturer L-phenylalanine Kyowa Hakko Bio Co., Ltd., Japan; Type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-alanine; proposed: R0-CEP 2007-351-Rev 03; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-arginine; proposed: R1-CEP 2010-045-Rev 00; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-valine; proposed: R1-CEP 2007-364-Rev 01; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-valine; proposed: R1-CEP 2008-128-Rev 01; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-histidine; proposed: R1-CEP 2010-046-Rev 01; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-isoleucine; proposed: R1-CEP 2004-228-Rev 02; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-isoleucine; proposed: R1-CEP 2010-188-Rev 00; submission of an new certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-leucine; proposed: R1-CEP 2010-189-Rev 00; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-methionine; proposed: R1-CEP 1999-136-Rev 05; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-proline; proposed: R1-CEP 2010-263-Rev 00; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-serine; proposed: R1-CEP 2006-315-Rev 02; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-serine; proposed: R1-CEP 2008-003-Rev 00; submission of an updated certificate of suitability to the European Pharmacopoeia from an approved API manufacturer of L-threonine; proposed: R1-CEP 2010-044-Rev 00; Type I variations – submission of a new certificate of suitability to the European Pharmacopoeia No. R0-CEP 2013-157-Rev 00 from a new API manufacturer of L-alanine Amino GMBH, Germany; submission of a new certificate of suitability to the European Pharmacopoeia No. R0-CEP 2014-227-Rev 00 from an approved API manufacturer of L-lysine monoacetate (L-lysine) Kyowa Hakko Bio Co., Ltd, Japan; submission of a new certificate of suitability to the European Pharmacopoeia No. R0-CEP 2014-132-Rev 00 from a new API manufacturer of L-phenylalanine Shanghai Ajinomoto Amino Acid Co., Ltd., China; submission of a new certificate of suitability to the European Pharmacopoeia from a new API manufacturer of L-methionine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China. No. R1-CEP 2005-190-Rev 02; Type I variations – change in the re-test period/shelf life or storage conditions of the API – specification of a re-test period of 24 months for L-alanine manufactured by Amino GmbH, Germany; change of the re-test period for Taurine manufactured by Kyowa Hakko Bio Co., Ltd, Japan from 12 to 36 months |
by prescription |
UA/4585/01/01 |
|
AMINOSTERIL N-HEPA |
solution for infusion; 500 ml per vial; 10 vials per cardboard box |
Fresenius Kabi Deutschland GmbH |
Germany |
Fresenius Kabi Austria GmbH |
Austria |
amendments to registration materials: Type I changes – deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the site of batch control) or of a supplier of a starting material, reagent or excipient – removal of the API manufacturer L-isoleucine Ajinomoto North America, Inc., USA; removal of the API manufacturer L-isoleucine Ajinomoto Co. Inc., Kawasaki Plant, Japan; removal of the API manufacturer L-leucine Ajinomoto Co. Inc., Kawasaki Plant, Japan; removal of the API manufacturer L-leucine Ajinomoto North America, Inc., USA; removal of the API manufacturer L-lysine monoacetate (L-lysine) Ajinomoto Co. Inc., Kawasaki Plant, Japan; removal of the API manufacturer L-serine Kyowa Hakko Bio Co., Ltd., Ube Plant, Japan; removal of the API manufacturer L-serine Evonik Rexim S.A.S. France; removal of the API manufacturer L-phenylalanine Kyowa Hakko Bio Co., Ltd., Hofu Plant, Japan; removal of the API manufacturer L-phenylalanine Ajinomoto Co. Inc., Tokai Plant., Japan; Type I changes: updated CEP from the approved API manufacturer L-alanine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R0-CEP 2007-351-Rev 03; updated CEP from the approved API manufacturer L-arginine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2010-045-Rev 00; updated CEP from the approved API manufacturer L-valine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2007-364-Rev 01;
updated CEP from the approved API manufacturer L-valine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China.; proposed: R1-CEP 2008-128-Rev 01; updated CEP from the approved API manufacturer L-histidine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-046-Rev 01; updated CEP from the approved API manufacturer L-isoleucine Amino GmbH, Germany; proposed: R1-CEP 2004-228-Rev 02; updated CEP from the approved API manufacturer L-isoleucine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-188-Rev 00; updated CEP from the approved API manufacturer L-leucine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-189-Rev 00; updated CEP from the approved API manufacturer L-methionine Sekisui Medical Co., Ltd., Japan; proposed: R1-CEP 1999-136-Rev 05; updated CEP from the approved API manufacturer L-proline Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-263-Rev 00;
updated CEP from the approved manufacturer of the API L-serine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2008-003-Rev 00; updated CEP from the approved manufacturer of the API L-serine Amino GmbH, Germany; proposed: R1-CEP 2006-315-Rev 02; updated CEP from the approved manufacturer of the API L-threonine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2010-044-Rev 00; Type I variations: new CEP No. R0-CEP 2013-157-Rev 00 from a new manufacturer of the API L-alanine Amino GMBH, Germany; new CEP No. R0-CEP 2014-227-Rev 00 from the approved manufacturer of the API L-lysine monoacetate (L-lysine) Kyowa Hakko Bio Co., Ltd, Hofu Plant, Japan; new CEP No. R0-CEP 2014-132-Rev 00 from a new manufacturer of the API L-phenylalanine Shanghai Ajinomoto Amino Acid Co., Ltd., China; new CEP No. R0-CEP 2014-063-Rev 00 from a new manufacturer of the API L-lysine monoacetate (L-lysine) Ajinomoto North America, Inc., USA; Type I variations: change of the re-test period/shelf life or storage conditions of the API – specification of a re-test period of 24 months for L-alanine manufactured by Amino GmbH, Germany |
by
prescription |
UA/0948/01/01 |
|
AMLODIPINE SANDOZ® |
tablets of 5 mg; 15 tablets per blister; 2 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (full-cycle manufacturing; primary and secondary packaging); S.C. Sandoz S.R.L., Romania (batch control); Sandoz Grup Saglik Urunleri Ilaclari San. ve Tic. A.S., Turkey (bulk manufacturing); Sandoz Ilac Sanayi ve Ticaret A.S., Turkey (bulk manufacturing) |
Slovenia/Romania/Turkey |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/11166/01/01 |
|
AMLODIPINE SANDOZ® |
tablets of 10 mg; 15 tablets per blister; 2 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (full-cycle manufacturing; primary and secondary packaging); S.C. Sandoz S.R.L., Romania (batch control); Sandoz Grup Saglik Urunleri Ilaclari San. ve Tic. A.S., Turkey (bulk manufacturing); Sandoz Ilac Sanayi ve Ticaret A.S., Turkey (bulk manufacturing) |
Slovenia/Romania/Turkey |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/11166/01/02 |
|
AMOXICLAV® QUICKTAB |
dispersible tablets, 500 mg/125 mg, 2 tablets in a blister; 5 or 10 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (full-cycle manufacturing; batch release) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/3011/04/02 |
|
ANAFERON |
tablets, 20 tablets per blister; 1 blister per cardboard box |
LLC “Materia Medica-Ukraine” |
Ukraine |
CJSC Santonika |
Lithuania |
amendments to registration materials: Type II variations – safety/efficacy and pharmacovigilance variations. Introduction of or change(s) to the obligations and conditions of the registration certificate, including the Risk Management Plan (implementation of change(s) that require further justification by new additional data to be provided to the competent authority, since a substantial evaluation by the competent authority is required) a detailed description of the risk management system is provided in the form of a risk management plan containing risk-proportionate measures for risk minimization and pharmacovigilance. The safety information presented in the package leaflet of the medicinal product reflects the risk minimization measures and corresponds to the information set out in the risk management plan submitted by the applicant |
without
prescription |
UA/2614/01/01 |
|
ARGETT SPRAY |
cutaneous spray, solution 4 %;
12,5 g or 25 g in a bottle with a dosing device and protective cap; 1 bottle in a carton box |
Delta Medical Promotions AG |
Switzerland |
Farbil Waltrop GmbH |
Germany |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder). Change of the applicant's address: Approved: 26 Ottenbachgasse, Zurich CH-8001, Switzerland
Proposed: 26 Otenbachgasse, Zurich CH-8001, Switzerland. Changes were made to the package leaflet regarding the applicant's location (correction of an address error), and consequently the corresponding changes to the packaging labeling text of the medicinal product. Implementation of changes within 6 months after approval. |
without prescription |
UA/12446/01/01 |
|
ARGETT SPRAY |
cutaneous spray, solution 4 %; 12,5 g or 25 g in a bottle with a metering device and a protective cap; 1 bottle in a cardboard box |
Delta Medical Promotions AG |
Switzerland |
Farbil Waltrop GmbH |
Germany |
introducing amendments to registration materials: Type I variations – change of the labeling text of the primary and secondary packaging of the finished medicinal product |
without
prescription |
UA/12446/01/01 |
|
ASPASMIN |
modified-release hard capsules, 200 mg; 10 capsules per blister; 3 blisters in a pack |
JSC “KYIV VITAMIN PLANT” |
Ukraine |
JSC “KYIV VITAMIN PLANT” |
Ukraine |
amendments to registration materials: Type I changes – change of the address of the manufacturer of the API mebeverine hydrochloride Nosch Labs Pvt. Ltd., India, without change of the manufacturing site |
by
prescription |
UA/14482/01/01 |
|
ASPARKAM |
solution for injection, 5 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a pack; 10 ml in an ampoule; 5 ampoule in a blister; 2 blisters in a pack |
PJSC “Halychpharm” |
Ukraine |
PJSC “Halychpharm” |
Ukraine |
amendments to registration materials: Type I variations – change in the specification parameters and/or acceptance limits for an excipient – bringing the specifications and control methods for the excipients Sorbitol, light magnesium oxide, and potassium hydroxide into compliance with the requirements of the Ph. Eur. monographs; consequential change: change in the test methods of the excipient |
by
prescription |
UA/1309/01/01 |
|
ASPIRIN CARDIO® |
gastro-resistant tablets, 100 mg, 14 tablets in a blister; 2 or 4 blisters in a cardboard pack |
Bayer Consumer Care AG |
Switzerland |
Production “in bulk”:
Bayer AG, Germany;
Primary and secondary packaging and batch release:
Bayer Bitterfeld GmbH, Germany |
Germany |
amendments to registration materials: Type II changes – Safety/efficacy and pharmacovigilance changes. Changes to the summary of product characteristics, labeling text and instructions for medical use in connection with new quality, preclinical, clinical and pharmacovigilance data – Changes were made to the instructions for medical use of the medicinal product in the sections: “Pharmacological properties”, “Contraindications”, “Interaction with other medicinal products and other forms of interaction”, “Special warnings and precautions for use”, “Children”, “Use during pregnancy or breastfeeding”, “Ability to affect reaction speed when driving or operating other machinery”, “Overdose”, “Adverse reactions”. Type II changes – Safety/efficacy and pharmacovigilance changes. Changes in therapeutic indications (addition of a new therapeutic indication or change to an approved indication) Changes were made to the instructions for medical use of the medicinal product in the section “Indications” |
without prescription |
UA/7802/01/01 |
|
ASPIRIN CARDIO® |
enteric-coated tablets, 300 mg each, 14 tablets per blister, 2 blisters per cardboard pack |
Bayer Consumer Care AG |
Switzerland |
Bayer AG, Germany;
Bayer Bitterfeld GmbH, Germany |
Germany |
amendments to registration materials: Type II variations – Variations concerning safety/efficacy and pharmacovigilance. Changes to the summary of product characteristics, labeling text and patient information leaflet due to new quality, preclinical, clinical and pharmacovigilance data – Changes were made to the following sections of the patient information leaflet of the medicinal product: “Pharmacological properties”, “Contraindications”, “Interaction with other medicinal products and other forms of interaction”, “Special warnings and precautions for use”, “Children”, “Use during pregnancy or breast-feeding”, “Effects on ability to drive and use machines”, “Overdose”, “Adverse reactions”. Type II variations – Variations concerning safety/efficacy and pharmacovigilance. Changes to therapeutic indications (addition of a new therapeutic indication or change to an approved indication) –
Changes made to the package leaflet of the medicinal product in the section “Indications” |
without prescription |
UA/7802/01/02 |
|
ASPRIX |
metered nasal spray, 15,75 mg/dose, 4 ml (40 doses) in a bottle; 1 bottle in a cardboard pack |
LLC NPF “MIKROKHIM” |
Ukraine |
LLC NPF “MIKROKHIM” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder). Change of the name and address of the applicant. Implementation of changes within 6 months after approval. Type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the site where quality control is performed (activity for which the manufacturer/importer is responsible, including batch release). Change of the name and address of the manufacturer of the finished medicinal product, without a change of the manufacturing site. Implementation of changes within 6 months after approval. |
by
prescription |
UA/14621/01/01 |
|
AUGMENTIN™ |
powder for oral suspension (200 mg/28,5 mg in 5 mL); 1 vial with powder for preparation of 70 mL of suspension with a measuring cap in a cardboard box |
GlaxoSmithKline Export Limited |
Great Britain |
Glaxo Wellcome Production, France; SmithKline Beecham Pharmaceuticals, United Kingdom |
France/United Kingdom |
amendments to registration materials: Type I variations – submission of a new European Pharmacopoeia Certificate of Suitability No. R0-CEP 2015-064-Rev 01 for the API Amoxicillin trihydrate Enzymatic process from an already approved manufacturer, resulting in an update of the API specification, which includes tests and acceptance criteria for the substance produced by the enzymatic process |
by
prescription |
UA/0987/05/01 |
|
ACETYLSALICYLIC ACID |
tablets of 500 mg, 10 tablets in strips; 10 tablets in blisters; 10 tablets in a blister; 2 blisters in a pack |
PJSC “Halychpharm” |
Ukraine |
PJSC “Kyivmedpreparat”, Ukraine, PJSC “Halychpharm” |
Ukraine |
amendments to registration materials:
technical error in the text of the secondary packaging labeling, namely the omission of international unit designations in Latin script. The specified correction conforms to the registration dossier materials |
without prescription |
UA/7529/01/01 |
|
ACIC® |
tablets of 200 mg, 5 tablets per blister; 5 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH |
Germany |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14584/01/01 |
|
ACIC® |
tablets of 400 mg, 5 tablets per blister; 7 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH |
Germany |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/14584/01/02 |
|
ACC® |
oral solution, 20 mg/ml, 100 ml or 200 ml in a vial; 1 vial with a measuring cap and/or measuring applicator (syringe) in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH, Germany (batch release); Pharma Wernigerode GmbH, Germany (bulk manufacturing, primary and secondary packaging, testing) |
Germany |
amendments to registration materials: Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant's qualified person responsible for pharmacovigilance |
without
prescription |
UA/8272/02/01 |
|
ACC® 100 |
powder for oral solution, 100 mg, 3 g of powder in a sachet; 20 sachets in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Zambon Switzerland Ltd., Switzerland (bulk production, testing, packaging); Lindopharm GmbH, Germany (bulk production, testing, packaging); Salutas Pharma GmbH, Germany (testing, packaging, batch release) |
Switzerland/ Germany |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
without
prescription |
UA/2030/02/01 |
|
ACC® 200 |
powder for oral solution, 200 mg, 3 g of powder in a sachet; 20 sachets in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Zambon Switzerland Ltd., Switzerland (bulk production, testing, packaging); Lindopharm GmbH, Germany (bulk production, testing, packaging); Salutas Pharma GmbH, Germany (testing, packaging, batch release) |
Switzerland/ Germany |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
without
prescription |
UA/2031/02/01 |
|
ACC® HOT DRINK HONEY LEMON |
powder for oral solution, 600 mg each; 3 g of powder in a sachet; 6 sachets in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Zambon Switzerland Ltd., Switzerland (bulk manufacturer, testing, packaging); Lindopharm GmbH, Germany (bulk manufacturer, testing, packaging); Salutas Pharma GmbH, Germany (batch release) |
Switzerland/ Germany |
amendments to registration materials: Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant's qualified person responsible for pharmacovigilance |
without
prescription |
UA/6568/02/01 |
|
ACC® HOT DRINK HONEY LEMON |
powder for oral solution, 200 mg each; 3 g of powder in a sachet; 20 sachets in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Zambon Switzerland Ltd., Switzerland (bulk manufacturer, testing, packaging); Lindopharm GmbH, Germany (bulk manufacturer, testing, packaging); Salutas Pharma GmbH, Germany (batch release) |
Switzerland/ Germany |
amendments to registration materials: Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant's qualified person responsible for pharmacovigilance |
without
prescription |
UA/6568/02/02 |
|
BANEOCIN |
ointment 5 g or 20 g in a tube; 1 tube in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Merck KGaA & Co Werk Spittal, Austria (bulk manufacturing, primary and secondary packaging); Sandoz GmbH-TechOps, Austria (batch release) |
Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/3951/01/01 |
|
BANEOCIN |
cutaneous powder, 10 g of powder per container; 1 container per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Sandoz GmbH-TechOps, Austria (batch release); Pharmazeutische Fabrik Montavit GmbH, Austria (bulk product manufacturer, packaging) |
Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/3951/02/01 |
|
BELOGENT |
ointment 15 g or 30 g in a tube; 1 tube in a cardboard pack |
Belupo, medicines and cosmetics, d.d. |
Croatia |
Belupo, medicines and cosmetics d.d. |
Croatia |
amendments to registration materials: Type I variations – introduction of an additional batch size of 1000 kg, in addition to the previously approved batch size of 500 kg; Type I variations – minor changes in the manufacturing process related to the introduction of an additional batch size of the finished medicinal product; Type I variations – change of acceptance limits in the specification for in-process control – parameter “individual fill mass” (“Mass variation”) for the 15 g package from 15,00-15,60 g to 15,00-16,20 g, for the 30 g package from 30,00-31,00 g to 30,00-32,00 g; Type I variations – deletion of a non-significant in-process test – testing of the average fill mass during control; proposed: “Mass variation”; Type I variations – minor change in the manufacturing process of the finished product – change of the hold time of the intermediate product (introduction of a storage time of 168 hours for the bulk before loading into primary containers) |
by
prescription |
UA/10920/02/01 |
|
BELOGENT |
cream 15 g or 30 g in a tube; 1 tube in a cardboard pack |
Belupo, medicines and cosmetics, d.d. |
Croatia |
Belupo, medicines and cosmetics d.d. |
Croatia |
amendments to registration materials: Type I variations – minor changes in the manufacturing process of the finished medicinal product; Type I variations – minor change in the manufacturing process of the finished product – change of the hold time of the intermediate product (introduction of a storage time of 168 hours for the bulk before filling into primary containers); Type I variations – introduction of an additional batch size of 1000 kg, in addition to the previously approved batch size of 500 kg; Type I variations – deletion of a non-significant in-process test – testing of the average fill mass during in-process control; proposed: “Mass variation”; Type I variations – change of the acceptance limits in the specification for in-process control – parameter “individual fill mass” (“Mass variation”) for a 15 g pack from 15,00-15,60 g to 15,00-16,20 g, for a 30 g pack from 30,00-31,00 g to 30,00-32,00 g. |
by
prescription |
UA/10920/01/01 |
|
BENZYL BENZOATE |
cream, 250 mg/g 40 g or 80 g in a tube; 1 tube in a pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: Type I variations – introduction of an additional batch size of the finished medicinal product 600 kg (approved size – 220 kg). Proposed wording of the batch size of the medicinal product: 220 kg (5500 tubes of 40 g; 2750 tubes of 80 g); Additional batch size of the medicinal product: 600 kg (15000 tubes of 40 g; 7500 tubes of 80 g) |
without
prescription |
UA/7134/01/01 |
|
BILOBIL® |
capsules, 40 mg, 10 capsules per blister, 2 or 6 blisters in a cardboard box |
KRKA, d.d., Novo Mesto |
Slovenia |
KRKA, d.d., Novo mesto, Slovenia (in bulk production, primary and secondary packaging, batch control and batch release); KRKA, d.d., Novo mesto, Slovenia (batch control) |
Slovenia |
amendments to registration materials: type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 2012-267-Rev 00 for the active substance Ginkgo dry extract, refined and quantified from an already approved manufacturer |
without
prescription |
UA/1234/01/02 |
|
BISOPROLOL SANDOZ® |
film-coated tablets, 5 mg, 10 tablets in a blister; 3 blisters in a cardboard box; 15 tablets in a blister; 2, or 4 or 6 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek S.A., Poland (alternative manufacturer – full-cycle manufacture; primary and secondary packaging, quality control and batch release); Salutas Pharma GmbH, Germany (full-cycle manufacture) |
Poland/ Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/4401/01/01 |
|
BISOPROLOL SANDOZ® |
film-coated tablets, 10 mg, 10 tablets in a blister; 3 blisters in a cardboard box; 15 tablets in a blister; 2, or 4 or 6 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek S.A., Poland (alternative manufacturer – full-cycle manufacture; primary and secondary packaging, quality control and batch release); Salutas Pharma GmbH, Germany (full-cycle manufacture) |
Poland/ Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/4401/01/02 |
|
BRONCHO-MUNAL® P |
hard capsules, 3,5 mg, 10 capsules per blister; 1 or 3 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (primary and secondary packaging, batch control, batch release); OM Pharma SA, Switzerland (bulk manufacture, batch control) |
Slovenia/ Switzerland |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/14268/01/01 |
|
BRONCHOSTOP® SYRUP |
syrup; 120 mL in a vial; 1 vial together with a measuring cup in a cardboard box |
Quisda Pharma GmbH |
Austria |
Quisda Pharma GmbH |
Austria |
amendments to registration materials: Type I variations – Safety/efficacy and pharmacovigilance variations (other changes) – update of the already approved labeling text of the primary and secondary packaging and the medicinal product quality control methods (MQCM). The indication of excipients (sucrose, glucose and fructose) in the composition of raspberry juice and of an excipient (propylene glycol) in the composition of raspberry flavoring is due to alignment with the European Commission guideline “Excipients in the labelling and package leaflet of medicinal products for human use” (EMA/CHMP/302620/2017) regarding excipients, with corresponding changes as a consequence in the “Composition” section of the MQCM. The composition of the medicinal product remains unchanged. Changes have been made to the package leaflet in the section “Composition” and, as a consequence, in the section “Special warnings and precautions for use” (Implementation of the changes within 6 months after approval) |
without prescription |
UA/9915/02/01 |
|
BUPRENORPHINE HYDROCHLORIDE |
sublingual tablets, 2 mg each, 10 tablets in a blister; 1 blister in a cardboard box; 25 tablets in a blister; 4 blisters in a cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials: Type I changes – introduction of a new manufacturer AREVIPHARMA GMBH, Germany, of the active substance Buprenorphine hydrochloride, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-346-Rev 01, in addition to the approved API manufacturer Macfarlan Smith Limited, United Kingdom. As a result, changes were made to the specification and control methods of the API, namely the introduction of the parameter “Residual organic solvents” with limits of not more than 0,3 (3000 ppm) methanol, not more than 0,15 % (1500 ppm) tert-butyl methyl ether, not more than 0,1 % (1000 ppm) butanol with the corresponding test method in accordance with the CEP of the manufacturer AREVIPHARMA GMBH, Germany |
by prescription |
UA/10493/01/01 |
|
BUPRENORPHINE HYDROCHLORIDE |
sublingual tablets, 4 mg each, 10 tablets per blister; 1 or 10 blisters in a cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials: Type I changes – introduction of a new manufacturer AREVIPHARMA GMBH, Germany, of the active substance Buprenorphine hydrochloride, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-346-Rev 01, in addition to the approved API manufacturer Macfarlan Smith Limited, United Kingdom. As a result, changes were made to the specification and control methods of the API, namely the introduction of the parameter “Residual organic solvents” with limits of not more than 0,3 (3000 ppm) methanol, not more than 0,15 % (1500 ppm) tert-butyl methyl ether, not more than 0,1 % (1000 ppm) butanol with the corresponding test method in accordance with the CEP of the manufacturer AREVIPHARMA GMBH, Germany |
by prescription |
UA/10493/01/02 |
|
BUPRENORPHINE HYDROCHLORIDE |
sublingual tablets, 8 mg each, 10 tablets per blister; 1 or 10 blisters in a cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials: Type I changes – introduction of a new manufacturer AREVIPHARMA GMBH, Germany, of the active substance Buprenorphine hydrochloride, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-346-Rev 01, in addition to the approved API manufacturer Macfarlan Smith Limited, United Kingdom. As a result, changes were made to the specification and control methods of the API, namely the introduction of the parameter “Residual organic solvents” with limits of not more than 0,3 (3000 ppm) methanol, not more than 0,15 % (1500 ppm) tert-butyl methyl ether, not more than 0,1 % (1000 ppm) butanol with the corresponding test method in accordance with the CEP of the manufacturer AREVIPHARMA GMBH, Germany |
by prescription |
UA/10493/01/03 |
|
BUPREXON-ZN |
sublingual tablets, 2 mg/0,5 mg, 10 tablets per blister; 1 or 5 blisters per cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials:
Type I variations – submission of a new European Pharmacopoeia certificate of suitability No. R1-CEP 2009-346-Rev 01 from a new manufacturer of the API Buprenorphine hydrochloride AREVIPHARMA GMBH, Germany |
by prescription |
UA/13443/01/01 |
|
BUPREXON-ZN |
sublingual tablets, 8 mg/2 mg, 10 tablets per blister; 1 or 5 blisters per cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials:
Type I variations – submission of a new European Pharmacopoeia certificate of suitability No. R1-CEP 2009-346-Rev 01 from a new manufacturer of the API Buprenorphine hydrochloride AREVIPHARMA GMBH, Germany |
by prescription |
UA/13443/01/02 |
|
BUPRENORPHINE HYDROCHLORIDE |
solution for injection, 0,3 mg/mL, 1 mL in an ampoule; 5 ampoules in a blister; 1 or 2, or 20 blisters in a cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
amendments to registration materials:
Type I variation – submission of a new Certificate of Suitability of the European Pharmacopoeia No. R1-CEP 2009-346-Rev 01 for the active substance buprenorphine hydrochloride from a new manufacturer. Supplementing the API Specification and control methods with the “Residual solvents” test according to the documentation of the new API manufacturer |
By prescription |
UA/6573/01/01 |
|
VALSARTAN |
powder (substance) in a polyethylene bag for pharmaceutical use |
VEZ Pharmachem d.o.o. |
Croatia |
Mylan Laboratories Limited |
India |
amendments to registration materials:
type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia, version R1-CEP 2009-396-Rev 04, and, as a consequence, update of the specification and quality control methods, namely: removal of the Heavy Metals test and introduction of an additional test for Nitrosamine Impurities: N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosopropylethylamine (NIPEA), N-nitrosodiisopropylamine (NDIPA), included in the CEP |
– |
UA/7168/01/01 |
|
VIKASOL-DARNYTSIA |
solution for injection, 10 mg/mL, 1 mL in an ampoule; 5 ampoules in a blister pack; 2 blister packs in a carton |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials: Type I variations – supplementing the specification of the finished medicinal product with the quality indicator “Bacterial endotoxins” with a limit of “less than 150 IU/ml” with the corresponding test method in accordance with the recommendations of the general monograph of the State Pharmacopoeia of Ukraine: Medicinal products for parenteral use. Implementation of changes within 6 months after approval; Type I variations – supplementing the API specification with the quality indicator “Bacterial endotoxins” with a limit of “less than 14 IU/mg” with the corresponding test method in accordance with the recommendations of the general monograph of the State Pharmacopoeia of Ukraine: Substances for pharmaceutical use. Implementation of changes within 6 months after approval |
by
prescription |
UA/6004/01/01 |
|
VINPOCETINE |
tablets of 0,005 g, in bulk: 3000 tablets in containers |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
amendment of registration materials: type II variations – change of the periodic control of the “Microbiological purity” parameter from batch-by-batch to selective (the first and every fifth batch) |
– |
UA/3219/01/01 |
|
VINPOCETINE |
tablets of 0,005 g, 10 tablets in a blister; 3 or 5 blisters in a pack; 10 tablets in a blister; 50 or 100 blisters in a pack |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
Private Joint-Stock Company “Lekhim-Kharkiv” |
Ukraine |
amendment of registration materials: type II variations – change of the periodic control of the “Microbiological purity” parameter from batch-by-batch to selective (the first and every fifth batch) |
by
prescription |
UA/3218/01/01 |
|
VIROTEC INTIM |
solution for external use 0,02%, 50 g per vial; 1 vial per pack |
LLC “VALARTIN PHARMA” |
Ukraine |
Limited Liability Company “Multispray” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of starting material, reagent or excipient (if specified in the dossier) – deletion of the manufacturing site of the finished medicinal product Pharmaceutical Factory of CE "Luhansk Regional "Pharmacy"", as a consequence of the deletion of the pack of 100 g in a vial; 1 vial in a pack, which was manufactured at this manufacturing site |
without prescription |
UA/9773/01/01 |
|
VIROTEC CLINIC |
solution for external use 0,05%, 250 g per vial; 1 vial per pack |
LLC “VALARTIN PHARMA” |
Ukraine |
Limited Liability Company “Multispray” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate product, or finished medicinal product, packaging sites, the manufacturer responsible for batch release, and the batch control site) or of a supplier of a starting material, reagent, or excipient (if specified in the dossier) – deletion of the manufacturing site of the finished medicinal product, the Pharmaceutical Factory of the Communal Enterprise "Luhansk Regional "Pharmacy," Ukraine, as a result of the withdrawal of the packaging of 100 g in a vial; 1 vial(s) per pack, which was produced at this manufacturing site |
without prescription |
UA/9773/01/02 |
|
VIRSO |
film-coated tablets, 400 mg each; 28 tablets per bottle, 1 bottle in a cardboard box |
Strides Pharma Science Limited |
India |
Strides Pharma Science Limited |
India |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the sales package (supported by real-time data) – extension of the shelf life of the finished medicinal product. Approved: 2 years. Proposed: 3 years. (Implementation of changes within 6 months after approval) |
by
prescription |
UA/17053/01/01 |
|
VOLVIT® |
film-coated tablets, 5 mg; 10 tablets per blister, 3 blisters in a cardboard pack |
KUSUM HEALTHCARE PVT LTD |
India |
KUSUM HEALTHCARE PVT LTD |
India |
amendments to registration materials:
Type I variation – changes to the Instructions for medical use of the medicinal product in the section “Special warnings and precautions for use” in accordance with PRAC recommendations. Implementation of the changes within 3 months after approval; concomitant change: changes concerning safety/efficacy and pharmacovigilance. Introduction of or change(s) to the obligations and conditions of the registration certificate, including the Risk Management Plan (use of the text agreed with the competent authority) |
without prescription |
UA/9290/01/01 |
|
VOLTAREN® |
solution for injection, 75 mg/3 ml; 3 ml per ampoule; 5 ampoules per cardboard box |
Novartis Pharma AG |
Switzerland |
Lek Pharmaceuticals d.d., Slovenia, Novartis Pharma Stein AG |
Switzerland |
amendments to registration materials:
Type I variations – safety/efficacy and pharmacovigilance variations. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: Qualified person of the applicant responsible for pharmacovigilance – David J Lewis, B.Sc (Hons), Ph.D. Change of contact details of the applicant’s qualified person responsible for pharmacovigilance |
by prescription |
UA/9812/01/01 |
|
GAVISCON® FORTE MINT SUSPENSION |
oral suspension, 150 ml or 300 ml in bottles; 10 ml in a sachet; 20 sachets in a cardboard box |
Reckitt Benckiser Healthcare (UK) Limited |
Great Britain |
Reckitt Benckiser Healthcare (UK) Limited |
Great Britain |
amendments to registration materials:
type II variations – changes were made to the instructions for medical use of the medicinal product in the sections: “Special precautions”, “Interaction with other medicinal products and other forms of interaction”. Implementation of the changes within 4 months after approval |
without prescription |
UA/6865/01/01 |
|
HELMINTOX |
film-coated tablets, 250 mg each, 3 tablets per blister; 1 blister in a cardboard box |
Laboratoire INNOTECH INTERNATIONAL |
France |
Innothera Chouzy |
France |
amendments to registration materials: Type I variation – submission of an updated European Pharmacopoeia Certificate of Suitability R1-CEP 2005-294-Rev 00 from the already approved manufacturer IPCA LABORATORIES LIMITED, India for the pyrantel embonate API |
without
prescription |
UA/10137/01/01 |
|
HELMINTOX |
film-coated tablets, 125 mg each, 6 tablets per blister, 1 blister in a cardboard box |
Laboratoire INNOTECH INTERNATIONAL |
France |
Innothera Chouzy |
France |
amendments to registration materials: Type I variation – submission of an updated European Pharmacopoeia Certificate of Suitability R1-CEP 2005-294-Rev 00 from the already approved manufacturer IPCA LABORATORIES LIMITED, India for the pyrantel embonate API |
without
prescription |
UA/10137/01/02 |
|
HELMINTOX |
oral suspension, 125 mg/2,5 ml, 15 ml in a bottle; 1 bottle with a measuring spoon in a cardboard box |
Laboratoire INNOTECH INTERNATIONAL |
France |
Innothera Chouzy |
France |
amendments to registration materials: Type I variations – change of the name and address of the manufacturer responsible for bulk manufacturing and packaging in subsection 3.2.R.3.1. Manufacturers, without change of manufacturing site; Type I variations – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 2005-294-Rev 00 from the already approved manufacturer IPCA LABORATORIES LIMITED, India, for the API pyrantel embonate |
without
prescription |
UA/10172/01/01 |
|
HEPARIZIN® |
solution for injection, 20 ml per ampoule; 10 ampoules per cardboard pack |
LLC “VALARTIN PHARMA” |
Ukraine |
LLC “Beijing Kawin Technology Share-Holding Co.” |
China |
amendments to registration materials: type II variations – change of the API (glycine) manufacturer with submission of a master file; proposed: Tianjin Tianjiao Pharmaceuticals Co., Ltd., China |
by
prescription |
UA/15589/01/01 |
|
GLIPTAR |
tablets 50 mg, 10 tablets per blister, 6 blisters per pack |
LLC “ARTERIUM LTD” |
Ukraine |
PJSC “Kyivmedpreparat” |
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data), extension of the shelf life of the finished medicinal product: Approved: 1 years Proposed: 2 years Implementation of the changes within 6 months after approval |
by prescription |
UA/16719/01/01 |
|
GLYCERIN |
solution for external use 85%, 25 g in vials |
PRJSC “FITOPHARM” |
Ukraine |
PRJSC “FITOPHARM” |
Ukraine |
amendments to registration materials: type I variations – change of the name and/or address of the manufacturer's site (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – change of the name of the manufacturer of the API distilled glycerin, without change of the manufacturing site |
without
prescription |
UA/8363/01/01 |
|
GLYCERIN SUPPOSITORIES |
suppositories of 0,88 g; 5 suppositories per strip; 1 or 2 strips per pack |
LLC “PHARMEX GROUP” |
Ukraine |
LLC “PHARMEX GROUP” |
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) – extension of the shelf life of the finished medicinal product: Approved: 2 years Proposed: 3 years (Implementation of the changes within 3 months after approval) |
without
prescription |
UA/14366/01/01 |
|
GLYCERIN SUPPOSITORIES |
suppositories of 2,63 g; 5 suppositories per strip; 1 or 2 strips per pack |
LLC “PHARMEX GROUP” |
Ukraine |
LLC “PHARMEX GROUP” |
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) – extension of the shelf life of the finished medicinal product: Approved: 2 years Proposed: 3 years (Implementation of the changes within 3 months after approval) |
without
prescription |
UA/14366/01/02 |
|
GLUCOSAMINE HYDROCHLORIDE |
powder (substance) in double polyethylene bags for pharmaceutical use |
PRJSC “FITOPHARM” |
Ukraine |
BIOIBERICA S.A.U. |
Spain |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer's site of operation (including, where necessary, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API (if specified in the medicinal product dossier) in the absence of a certificate of suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier). Change of the address of the API manufacturer BIOIBERICA S.A.U., Spain, without changing the manufacturing site. |
– |
UA/16797/01/01 |
|
GRANUFINK® PROSTA FORTE |
hard capsules; 10 capsules in a blister; 2 or 4, or 8, or 14 blisters in a cardboard pack; 20 capsules in a blister with a perforation line; 2 or 4, or 7 blisters in a cardboard pack |
LLC “OMEGA PHARMA UKRAINE” |
Ukraine |
Omega Pharma Manufacturing GmbH & Co. KG |
Germany |
amendments to registration materials: type I variations – Quality changes. Finished medicinal product. Container closure system. Change in shape or dimensions of the container or closure (primary packaging) (non-sterile medicinal products) – change in the shape and dimensions of the primary packaging, namely: introduction of an additional pack of 20 capsules in a blister with a perforation line, 2 or 4 or 7 blisters in a cardboard box. Changes were made to the package leaflet of the medicinal product in the section "Packaging". |
without
prescription |
UA/16191/01/01 |
|
GRIPGO HOTMIX® |
granules for oral solution with lemon flavor, 5 g in a sachet, 5 or 10, or 20, or 50 sachets in a cardboard pack |
KUSUM HEALTHCARE PVT LTD |
India |
KUSUM HEALTHCARE PVT LTD |
India |
amendments to registration materials: type I variations – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (a site where any manufacturing stages are carried out, except batch release, quality control, primary and secondary packaging, for non-sterile medicinal products)
Concomitant change
– Quality variations. Finished medicinal product. Manufacturing changes. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for secondary packaging) – quality variations. Finished medicinal product. Manufacturing changes. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for primary packaging) – addition of a manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, PIN 454774, India; Type I variations – Quality variations. Finished medicinal product. Manufacturing changes. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a manufacturer responsible for import and/or batch release) – including batch control/testing – addition of a manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, PIN 454774, India |
without prescription |
UA/16502/01/01 |
|
DEMOPENEM® |
powder for solution for injection, 500 mg, 1 vial of powder per cardboard package |
Abril Formulations Pvt. Ltd. |
India |
DEMO S.A. Pharmaceutical Industry |
Greece |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial package (supported by real-time data), extension of the shelf life of the finished medicinal product based on positive results of long-term real-time stability studies:
Approved: Shelf life. 3 years Proposed: Shelf life. 4 years |
by
prescription |
UA/14759/01/02 |
|
DEMOPENEM® |
powder for solution for injection, 1000 mg, 1 vial of powder per cardboard package |
Abril Formulations Pvt. Ltd. |
India |
DEMO S.A. Pharmaceutical Industry |
Greece |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial package (supported by real-time data), extension of the shelf life of the finished medicinal product based on positive results of long-term real-time stability studies:
Approved: Shelf life. 3 years Proposed: Shelf life. 4 years |
by
prescription |
UA/14759/01/01 |
|
DEPAKINE® |
syrup, 57,64 mg/mL, No. 1: 150 mL per bottle; 1 bottle with a dosing device with a stopper-adapter per carton box |
LLC “Sanofi-Aventis Ukraine” |
Ukraine |
Uniter Liquid Manufacturing |
France |
amendments to registration materials: Type I variation – bringing the Specification for the excipient Sucrose solution into compliance with the requirements of the French Pharmacopoeia monograph. “Odor” removed from the description, the “Lead” test removed, and the acceptance criteria for the “Microbiological purity” test brought into compliance with the requirements of the Eur.Pharm |
by
prescription |
UA/3817/01/01 |
|
DE-SPAN® |
solution for injection, 25 mg/mL; 2 mL in an ampoule; 5 ampoules in a cassette in a pack; 2 mL in an ampoule; 5 ampoules in a cassette; 2 cassettes in a pack |
Limited Liability Company Scientific and Production Firm “MIKROKHIM” |
Ukraine |
responsible for manufacture and control/testing of the batch, not including batch release:
Private Joint-Stock Company “Lekhim-Kharkiv”,
Ukraine
responsible for manufacturing and batch control/testing, including batch release:
Limited Liability Company Scientific and Production Firm “MIKROKHIM”,
Ukraine |
Ukraine |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (a site where any manufacturing stages are carried out, except for batch release, quality control and secondary packaging for sterile medicinal products (including those manufactured by aseptic methods), other than medicinal products of biological/immunological origin) addition of a manufacturing site for the entire manufacturing process of the finished medicinal product – Limited Liability Company Scientific and Production Firm “MIKROKHIM”, Ukraine. Implementation of changes within 3 months after approval. Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for secondary packaging) addition of a manufacturing site for secondary packaging of the finished medicinal product – Limited Liability Company Scientific and Production Firm “MIKROKHIM”, Ukraine. Implementation of changes within 3 months after approval. Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a manufacturer responsible for import and/or batch release) – Including batch control/testing
addition of a manufacturer responsible for batch release, including batch control/testing – Limited Liability Company Scientific and Production Firm “MIKROKHIM”, Ukraine. Changes were also made to the package leaflet of the medicinal product in the “Manufacturer” section. Implementation of changes within 3 months after approval. |
by
prescription |
UA/16880/01/01 |
|
JARDIANCE® |
film-coated tablets 25 mg, 10 tablets in a perforated blister; 1 or 3 blisters in a cardboard box |
Boehringer Ingelheim International GmbH |
Germany |
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany (manufacturing, packaging, labeling, quality control, batch release); PharmLog Pharma Logistik GmbH, Germany (alternative site for secondary packaging); Stegemann Lonferpakungen und Logistischer Service e. K., Germany (alternative site for secondary packaging) |
Germany |
amendments to registration materials:
Type I variations – change of the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or the site of quality control – change of the name of an alternative laboratory for quality control by the indicator microbiological purity, in section 3.2.P.3.1. |
by prescription |
UA/14980/01/01 |
|
JARDIANCE® |
film-coated tablets 10 mg, 10 tablets in a perforated blister; 1 or 3 blisters in a cardboard box |
Boehringer Ingelheim International GmbH |
Germany |
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany (manufacturing, packaging, labeling, quality control, batch release); PharmLog Pharma Logistik GmbH, Germany (alternative site for secondary packaging); Stegemann Lonferpakungen und Logistischer Service e. K., Germany (alternative site for secondary packaging) |
Germany |
amendments to registration materials:
Type I variations – change of the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or the site of quality control – change of the name of an alternative laboratory for quality control by the indicator microbiological purity, in section 3.2.P.3.1. |
by prescription |
UA/14980/01/02 |
|
DIGOXIN |
tablets of 0,25 mg, 20 tablets per blister; 2 blisters per cardboard pack |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
amendments to registration materials: type I variations – submission of an updated CEP No. R1-CEP 2010-042-Rev 01 for digoxin API from an already approved manufacturer
Type I variation – changes to tests or acceptance limits established in the specifications during manufacture of the finished medicinal product – deletion of the parameter "Microbiological purity" from the in-process control specification for the intermediate product during manufacture (tablets in blisters), since the medicinal product is manufactured under GMP conditions; amendment of the specification for the intermediate product Bulk tablets for the parameters: – "Average weight" and "Uniformity of weight of tablets" brought into compliance with the requirements of the SPhU, 2.9.5; – "Dissolution" – editorial correction of the wording of the acceptance criterion
Type I changes – change in the parameters of the specifications and/or acceptance limits of the finished medicinal product – changes to the specification and control methods of the finished medicinal product for the following parameters: – “Uniformity of dosage units”: the specification was brought into line with the requirements of EP/SPhU 2.9.40.; – “Microbiological purity” – brought into line with the requirements of EP/SPhU; Type I changes – change in the test methods of the finished medicinal product – changes to the test procedure of the finished medicinal product for the parameter “Dissolution”, namely clarifications on the use of the filter were introduced (a hydrophilic filter (PTFE) with a diameter of 13 mm and a pore size of 0,2 μm from Millex® (catalog number SLLGH13NL) is used for filtration); and, as a consequence, corresponding changes to the test procedure for the “Dissolution” parameter for control of the intermediate product Bulk tablets; concomitant change: changes to tests or acceptance limits set in the specifications during manufacture of the finished medicinal product; Type I changes – change of supplier of packaging materials or components – changes to section 3.2.P.7. of the registration dossier, namely removal of the names of packaging material suppliers; specifications and control methods for packaging materials unchanged, no removals of packaging components or accessories occurred |
by
prescription |
UA/7365/01/01 |
|
DIGOXIN |
tablets of 0,25 mg in bulk: 1 kg of tablets in a double polyethylene bag |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
amendments to registration materials: type I variations – submission of an updated CEP No. R1-CEP 2010-042-Rev 01 for digoxin API from an already approved manufacturer
Type I variation – changes to tests or acceptance limits established in the specifications during manufacture of the finished medicinal product – deletion of the parameter "Microbiological purity" from the in-process control specification for the intermediate product during manufacture (tablets in blisters), since the medicinal product is manufactured under GMP conditions; amendment of the specification for the intermediate product Bulk tablets for the parameters: – "Average weight" and "Uniformity of weight of tablets" brought into compliance with the requirements of the SPhU, 2.9.5; – "Dissolution" – editorial correction of the wording of the acceptance criterion
Type I changes – change in the parameters of the specifications and/or acceptance limits of the finished medicinal product – changes to the specification and control methods of the finished medicinal product for the following parameters: – “Uniformity of dosage units”: the specification was brought into line with the requirements of EP/SPhU 2.9.40.; – “Microbiological purity” – brought into line with the requirements of EP/SPhU; Type I changes – change in the test methods of the finished medicinal product – changes to the test procedure of the finished medicinal product for the parameter “Dissolution”, namely clarifications on the use of the filter were introduced (a hydrophilic filter (PTFE) with a diameter of 13 mm and a pore size of 0,2 μm from Millex® (catalog number SLLGH13NL) is used for filtration); and, as a consequence, corresponding changes to the test procedure for the “Dissolution” parameter for control of the intermediate product Bulk tablets; concomitant change: changes to tests or acceptance limits set in the specifications during manufacture of the finished medicinal product; Type I changes – change of supplier of packaging materials or components – changes to section 3.2.P.7. of the registration dossier, namely removal of the names of packaging material suppliers; specifications and control methods for packaging materials unchanged, no removals of packaging components or accessories occurred |
– |
UA/11082/01/01 |
|
DIFLUZOL® |
solution for infusion, 2 mg/ml, 100 ml per glass bottle; 1 bottle per pack |
PJSC “Halychpharm” |
Ukraine |
PJSC “Halychpharm” |
Ukraine |
amendments to registration materials: Type I variations – Variations concerning safety/efficacy and pharmacovigilance. Changes to the summary of product characteristics, labeling text and patient information leaflet of generic/hybrid/biosimilar medicinal products following the implementation of the same change for the reference product (the change does not require any new additional data) – changes were made to the following sections of the patient information leaflet of the medicinal product: “Pharmacological properties”, “Indications” (clarification of information), “Interaction with other medicinal products and other forms of interaction”, “Special warnings and precautions for use”, “Use during pregnancy or breast-feeding”, “Method of administration and doses” (text editing), “Children” (clarification of information), “Overdose”, “Adverse reactions”, in accordance with the information on the medical use of the reference medicinal product (DIFLUCAN®, solution for infusion, 2 mg/ml) |
by prescription |
UA/11674/01/01 |
|
DIFLUZOL® |
solution for infusion, 2 mg/ml, 100 ml per glass bottle; 1 bottle per pack |
PJSC “Halychpharm” |
Ukraine |
PJSC “Halychpharm” |
Ukraine |
amendments to registration materials:
Type I variation – change of supplier of packaging materials or components – amendments to the registration dossier materials, section 3.2.P.7. Container closure system: removal of information on manufacturers of the primary packaging (glass bottles (vials), rubber stoppers and aluminum caps) |
By prescription |
UA/11674/01/01 |
|
DIKLOTOL® |
coated tablets, 100 mg each, 10 tablets per blister; 3 or 10 blisters in a carton; 14 tablets per blister; 2 blisters in a carton |
KUSUM HEALTHCARE PVT LTD |
India |
KUSUM HEALTHCARE PVT LTD |
India |
amendments to registration materials: type I variations – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (a site where any manufacturing stages are carried out, except batch release, quality control, primary and secondary packaging, for non-sterile medicinal products)
Concomitant change
– Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (secondary packaging site);
- Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for primary packaging) - introduction of an additional manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, Pin 454774, India; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a manufacturer responsible for import and/or batch release) - including batch control/testing - introduction of an additional manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, Pin 454774, India |
by prescription |
UA/12364/01/01 |
|
DIOFLAN® |
film-coated tablets, 500 mg; 10 tablets in a blister; 3 or 6 blisters in a cardboard pack |
PJSC “Kyivmedpreparat” |
Ukraine |
PJSC “Kyivmedpreparat” |
Ukraine |
amendments to registration materials:
type I variations – update of the already approved text of the secondary packaging labeling of the medicinal product, namely supplementing the labeling text with data on the method of administration and dose of the medicinal product. Implementation of the changes within 6 months after approval |
without prescription |
UA/10773/01/01 |
|
DOREZ® |
film-coated tablets, 2,5 mg each, 10 tablets per blister; 3 blisters in a cardboard box |
ALKALOID AD Skopje |
Republic of Macedonia |
Alkaloid AD – Skopje |
Republic of Macedonia |
amendments to registration materials:
Type I variations – change in the test methods of the finished medicinal product (other changes to test methods (including replacement or addition)); Type I variations – change in the test methods of the finished medicinal product (minor change to approved test methods) – changes in the control methods of the finished medicinal product: – for the indicator "Identification of Titanium dioxide", the heating time (30 min) of the solution is specified; – for the indicator "Dissolution", changes in the preparation of the test solution in accordance with EP and the filter type is re-specified (0,20 µm regenerated cellulose membrane filter). The acceptance criteria did not change |
by prescription |
UA/11285/01/01 |
|
DOREZ® |
film-coated tablets, 5 mg each, 10 tablets per blister; 3 blisters in a cardboard box |
ALKALOID AD Skopje |
Republic of Macedonia |
Alkaloid AD – Skopje |
Republic of Macedonia |
amendments to registration materials:
Type I variations - change in the test methods of the finished medicinal product (other changes in test methods (including replacement or addition)); Type I variations - change in the test methods of the finished medicinal product (minor change to approved test methods) - changes in the control methods of the finished medicinal product: - for the parameter “Identification of Titanium dioxide”, the heating time (30 min) of the solution is specified; - for the parameter “Identification of Iron and iron oxide”, minor changes in the method: the specificity of the method has been increased and the boiling temperature has been specified; - for the parameter “Dissolution”, changes in the preparation of the test solution in accordance with the EP and a re-determined filter type (0,20 μm regenerated cellulose membrane filter). The acceptance criteria have not changed |
by prescription |
UA/11285/01/02 |
|
DOREZ® |
film-coated tablets, 10 mg each, 10 tablets per blister; 3 blisters in a cardboard box |
ALKALOID AD Skopje |
Republic of Macedonia |
Alkaloid AD – Skopje |
Republic of Macedonia |
amendments to registration materials:
Type I variations - change in the test methods of the finished medicinal product (other changes in test methods (including replacement or addition)); Type I variations - change in the test methods of the finished medicinal product (minor change to approved test methods) - changes in the control methods of the finished medicinal product: - for the parameter “Identification of Titanium dioxide”, the heating time (30 min) of the solution is specified; - for the parameter “Identification of Iron and iron oxide”, minor changes in the method: the specificity of the method has been increased and the boiling temperature has been specified; - for the parameter “Dissolution”, changes in the preparation of the test solution in accordance with the EP and a re-determined filter type (0,20 μm regenerated cellulose membrane filter). The acceptance criteria have not changed |
by prescription |
UA/11285/01/03 |
|
DOREZ® |
film-coated tablets, 10 mg each, 10 tablets per blister; 3 blisters in a cardboard box |
Alkaloid AD – Skopje |
Republic of Macedonia |
Alkaloid AD – Skopje |
Republic of Macedonia |
amendments to the registration materials: correction of a technical error in the quality control methods, in the “Composition” section |
by
prescription |
UA/11285/01/03 |
|
DOTAVIST |
solution for injection, 279,32 mg/mL (0,5 mmol/mL), 5 mL, 10 mL, 15 mL, 20 mL, 60 mL, 100 mL in vials, 1 vial in packs |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: type I variations – introduction of an additional batch size of the finished medicinal product. Proposed wording: 100 L (5 mL – 18 200 vials, 10 mL – 9 340 vials, 15 mL – 6 320 vials, 20 mL – 4 780 vials, 60 mL – 1 610 vials, 100 mL – 970 vials)
200 L (5 mL – 36 400 vials, 10 mL – 18 680 vials, 15 mL – 12 640 vials, 20 mL – 9 560 vials, 60 mL – 3 220 vials, 100 mL – 1 940 vials); 400 L (5 mL – 72 800 vials, 10 mL – 37 360 vials, 15 mL – 25 280 vials, 20 mL – 19 120 vials, 60 mL – 6 440 vials, 100 mL – 3 880 vials) |
by
prescription |
UA/16798/01/01 |
|
DUOTRAV® |
eye drops, 2,5 mL in a dropper bottle; 1 dropper bottle in an intermediate package placed in a cardboard box |
Novartis Pharma AG |
Switzerland |
Alcon-Couvreur |
Belgium |
amendments to registration materials:
Type I variations – variations concerning safety/efficacy and pharmacovigilance. Introduction of, or changes to, the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the qualified person responsible for pharmacovigilance: Proposed wording – David J Lewis, B.Sc (Hons), Ph.D. Change of the applicant’s contact person responsible for pharmacovigilance in Ukraine: Current wording – Yuliia Sereda. Proposed wording – Viacheslav Orlov. Change of the contact details of the qualified person responsible for pharmacovigilance and of the contact person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/6292/01/01 |
|
EXO-DERM |
cutaneous solution, 10 mg/mL, 8 mL or 20 mL in a vial sealed with a dropper stopper and closed with a cap; 1 vial per cardboard box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API; concomitant change: change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – changes in the specification and control methods of the API Naftifine hydrochloride in order to bring them into line with the manufacturer's documentation (DMF) and the current edition of the United States Pharmacopeia (USP); Type I changes – change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – changes in the quality control method of the API Naftifine hydrochloride for the parameter “Microbiological purity” in order to bring it into line with the requirements of the State Pharmacopoeia of Ukraine; Type II changes – change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the API, or change of the manufacturer (including, where necessary, the quality control site) of the API – (introduction of a new API manufacturer with submission of the API master file); Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API – change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – introduction of a new manufacturer of the API Naftifine hydrochloride, Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., China, with submission of the API master file, in addition to the approved API manufacturer OLON S.Р.A., Italy; as a consequence, introduction into the specification and control methods of the API of the parameters “Description” and “Residual organic solvents” from the new manufacturer |
without prescription |
UA/13758/01/01 |
|
EXO-DERM |
cutaneous solution, 10 mg/mL in bulk: 10 L or 50 L in metal KEG barrels |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API; concomitant change: change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – changes in the specification and control methods of the API Naftifine hydrochloride in order to bring them into line with the manufacturer's documentation (DMF) and the current edition of the United States Pharmacopeia (USP); Type I changes – change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – changes in the quality control method of the API Naftifine hydrochloride for the parameter “Microbiological purity” in order to bring it into line with the requirements of the State Pharmacopoeia of Ukraine; Type II changes – change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the API, or change of the manufacturer (including, where necessary, the quality control site) of the API – (introduction of a new API manufacturer with submission of the API master file); Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API – change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – introduction of a new manufacturer of the API Naftifine hydrochloride, Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., China, with submission of the API master file, in addition to the approved API manufacturer OLON S.Р.A., Italy; as a consequence, introduction into the specification and control methods of the API of the parameters “Description” and “Residual organic solvents” from the new manufacturer |
– |
UA/15493/01/01 |
|
ENALAPRIL |
tablets of 0,01 g, 10 tablets per blister; 2 or 10 blisters per cardboard pack |
PJSC “Khimfarmzavod “Chervona Zirka”” |
Ukraine |
PJSC “Khimfarmzavod “Chervona Zirka”” |
Ukraine |
Amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Container/closure system. Change in pack size of the finished medicinal product (change in the number of units (e.g. tablets, ampoules, etc.) in a pack:) – Change outside the range of approved pack sizes – addition of a new pack size, namely: No. 100 (10x10) in blisters in a cardboard carton, with corresponding changes to the section “Packaging” (Implementation of changes within 3 months after approval) |
by prescription |
UA/6582/01/01 |
|
ENALAPRIL-ASTRAPHARM |
tablets, 10 mg each, 10 tablets per blister, 2, 6, 9 or 10 blisters in a cardboard box |
LLC “ASTRAPHARM” |
Ukraine |
LLC “ASTRAPHARM” |
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (change in the number of units (e.g., tablets, ampoules, etc.) in the package:) – Change outside the range of the approved pack sizes – introduction of an additional pack size No. 60 (10x6) and No. 90 (10x9) in blisters, without change of the primary packaging material, with corresponding changes in the section “Packaging” |
by prescription |
UA/5232/01/02 |
|
ENALAPRIL-ASTRAPHARM |
tablets, 20 mg each, 10 tablets per blister, 2, 6, 9 or 10 blisters in a cardboard box |
LLC “ASTRAPHARM” |
Ukraine |
LLC “ASTRAPHARM” |
Ukraine |
Amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Container/closure system. Change in pack size of the finished medicinal product (change in the number of units (e.g. tablets, ampoules, etc.) in a pack:) – Change outside the range of approved pack sizes – introduction of additional pack sizes No. 60 (10x6) and No. 90 (10x9) in blisters, without change of the primary packaging material, with corresponding changes in the “Packaging” section |
by prescription |
UA/5232/01/03 |
|
ERIDEZ-DARNYTSIA |
film-coated tablets, 5 mg, 10 tablets in a blister pack; 1 or 2 or 3 blister packs in a pack |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials: type I variations – change of the address of the API manufacturer Vasudha Pharma Chem Limited, India, without change of the manufacturing site. Implementation of the changes within 6 months after approval |
without
prescription |
UA/12919/01/01 |
|
ESOZOL |
Lyophilizate for solution for injection and infusion, 40 mg, 1 or 10 vials with lyophilizate in a cardboard package |
LLC “ASHA Formulations” |
Ukraine |
STERIL-GENE LIFE SCIENCES (P) LTD |
India |
amendments to registration materials: Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: Andrii Vasyliovych Ivanytskyi. Change of the contact details of the applicant's qualified person responsible for pharmacovigilance |
by
prescription |
UA/14382/01/01 |
|
COMFREY OINTMENT |
ointment, 40 g in a tube per pack, 50 g or 100 g in a jar per pack |
PRJSC “FITOPHARM” |
Ukraine |
PRJSC “FITOPHARM” |
Ukraine |
amendments to registration materials: Type I variations – changes concerning safety/efficacy and pharmacovigilance – update of the approved labeling text of the primary packaging of the medicinal product (the sections “Indications” and “Method of administration and doses” were removed from the labeling text of the primary packaging (jar (label)). Implementation of changes within 6 months after approval |
without
prescription |
UA/17214/01/01 |
|
ZOLMIGREN® SPRAY |
metered nasal spray, 2,5 mg/dose, 2 ml (20 doses) in a bottle; 1 bottle in a cardboard pack |
PJSC “Farmak” |
Ukraine |
LLC Scientific and Production Firm “MIKROKHIM” |
Ukraine |
amendments to registration materials: Type I variations – deletion of the parameter “Residual organic solvents” from the Specification for the API Zolmitriptan and the corresponding test method; Type I variations – changes to the Specification for the API Zolmitriptan, addition of references to the SPhU pharmacopoeial methods for the parameters “Loss on drying” and “Assay”; Type I variations – changes to the test procedure for control of the API Zolmitriptan by the parameter “Assay”. Change in the preparation of the test and blank solutions |
by
prescription |
UA/15215/01/01 |
|
ZOLMIGREN® SPRAY |
metered nasal spray, 5 mg/dose, 2 ml (20 doses) in a bottle; 1 bottle in a cardboard pack |
PJSC “Farmak” |
Ukraine |
LLC Scientific and Production Firm “MIKROKHIM” |
Ukraine |
amendments to registration materials: Type I variations – deletion of the parameter “Residual organic solvents” from the Specification for the API Zolmitriptan and the corresponding test method; Type I variations – changes to the Specification for the API Zolmitriptan, addition of references to the SPhU pharmacopoeial methods for the parameters “Loss on drying” and “Assay”; Type I variations – changes to the test procedure for control of the API Zolmitriptan by the parameter “Assay”. Change in the preparation of the test and blank solutions |
by
prescription |
UA/15215/01/02 |
|
IBRANCE |
capsules of 75 mg, 7 capsules per blister; 3 blisters per cardboard box |
PFIZER H.C.P. CORPORATION |
USA |
Pfizer Manufacturing Deutschland GmbH |
Germany |
amendments to registration materials:
Type II variations – amendments to the Instructions for medical use of the medicinal product in the sections “Pharmacological properties,” “Interaction with other medicinal products and other forms of interaction,” “Method of administration and doses,” “Adverse reactions.”
Changes to the summary of product characteristics in sections: 4.2. Posology and method of administration; 4.6 Interaction with other medicinal products and other forms of interaction; 4.9. Adverse reactions; 5.1 Pharmacodynamic properties. Implementation of changes within 3 months after approval |
by prescription |
UA/15747/01/01 |
|
IBRANCE |
capsules of 100 mg, 7 capsules per blister; 3 blisters per cardboard box |
PFIZER H.C.P. CORPORATION |
USA |
Pfizer Manufacturing Deutschland GmbH |
Germany |
amendments to registration materials:
Type II variations – amendments to the Instructions for medical use of the medicinal product in the sections “Pharmacological properties,” “Interaction with other medicinal products and other forms of interaction,” “Method of administration and doses,” “Adverse reactions.”
Changes to the summary of product characteristics in sections: 4.2. Posology and method of administration; 4.6 Interaction with other medicinal products and other forms of interaction; 4.9. Adverse reactions; 5.1 Pharmacodynamic properties. Implementation of changes within 3 months after approval |
by prescription |
UA/15747/01/02 |
|
IBRANCE |
capsules of 125 mg, 7 capsules per blister; 3 blisters per cardboard box |
PFIZER H.C.P. CORPORATION |
USA |
Pfizer Manufacturing Deutschland GmbH |
Germany |
amendments to registration materials:
Type II variations – amendments to the Instructions for medical use of the medicinal product in the sections “Pharmacological properties,” “Interaction with other medicinal products and other forms of interaction,” “Method of administration and doses,” “Adverse reactions.”
Changes to the summary of product characteristics in sections: 4.2. Posology and method of administration; 4.6 Interaction with other medicinal products and other forms of interaction; 4.9. Adverse reactions; 5.1 Pharmacodynamic properties. Implementation of changes within 3 months after approval |
by prescription |
UA/15747/01/03 |
|
ILOMEDIN |
concentrate for solution for infusion, 20 mcg/ml, 1 ml per ampoule, 5 ampoules per cardboard box |
Bayer AG |
Germany |
Berlimed S.A. |
Spain |
amendments to registration materials: Type I variations - changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for conducting pharmacovigilance in Ukraine, if different from the person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) - change of the person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of the contact details of the person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the location of the master file |
by
prescription |
UA/3658/01/01 |
|
IMOVAX POLIO® VACCINE FOR THE PREVENTION OF POLIOMYELITIS, INACTIVATED, LIQUID |
suspension for injection, 0,5 ml (1 dose) in a pre-filled syringe with an attached needle (or 2 separate needles). 1 syringe in a carton box, together with the instructions for use. 1 syringe in a carton box containing the standard export packaging and the instructions for medical use. Suspension for injection, 5 ml (10 doses) in vials No. 1 or No. 10. 1 or 10 vials in a carton box, together with the instructions for use. 1 or 10 vials in a carton box containing the standard export packaging and the instructions for medical use |
Sanofi Pasteur S.A. |
France |
full manufacturing cycle, batch release: Sanofi Pasteur, France; secondary packaging: Sanofi-Aventis Private Co. Ltd., Hungary; syringe filling, quality control (sterility): SANOFI WINTHROP INDUSTRIE, France |
France/Hungary/France |
amendments to registration materials: Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API – addition of a sterility test for the pooled crude cell harvest (Crude Harvests Types 1, 2 and 3) in buildings V9 and V15 of the Marcy-l'Étoile manufacturing site, France, prior to the filtration step; Type I changes – change in the specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API – deletion of the sterility test for the single cell harvest obtained from one production run (Singl Virus Harvests Types 1, 2 and 3) in buildings V9 and V15 of the Marcy-l'Étoile manufacturing site, France; Type II changes – change in the batch size (including ranges) of the API or of an intermediate used in the manufacturing process of the API – increase of the batch size from 1500 L to 3000 L in building V15 of the Marcy-l'Étoile manufacturing site, France, for the manufacturing process of the monovalent inactivated poliomyelitis vaccine (IPV) on Vero cells. Introduction of editorial corrections to the sections of module 3: 3.2.S.2.2, 3.2.S.2.3, 3.2.S.2.4, 3.2.S.2.5, 3.2.S.2.6, 3.2.S.3.1, 3.2.S.3.2, 3.2.S.4.1, 3.2.S.4.4, 3.2.S.7.1, 3.2.S.7.3; Type II changes – changes in the manufacturing process of the API – implementation of a filtration sequence for the crude cell harvest instead of the purification step using the diatomite clarifying agent; Type II changes – change in the immediate packaging of the API – introduction of an alternative stainless steel tank in buildings V9 and V15 of the Marcy-l'Étoile manufacturing site, France, for the storage of inactivated monovalent APIs |
by
prescription |
UA/14266/01/01 |
|
IN-ALITER |
tablets of 4 mg/1,25 mg, 10 tablets per blister, 3 blisters per cardboard pack |
LIMITED LIABILITY COMPANY SCIENTIFIC AND PRODUCTION FIRM “MIKROKHIM” |
Ukraine |
LIMITED LIABILITY COMPANY SCIENTIFIC AND PRODUCTION FIRM "MIKROKHIM", Ukraine (registered address and laboratory of physicochemical analysis and production control; storage of finished products and materials; production site (all stages of the production process); biological analysis laboratory) |
Ukraine |
amendments to registration materials: Type I changes – introduction of additional batch sizes of the finished medicinal product. Proposed wording Batch size: 80 000 tablets, 240 000 tablets, 480 000 tablets |
by
prescription |
UA/17135/01/02 |
|
IN-ALITER |
tablets of 8 mg/2,5 mg, 10 tablets per blister, 3 blisters per cardboard pack |
LLC NPF “MIKROKHIM” |
Ukraine |
LIMITED LIABILITY COMPANY SCIENTIFIC AND PRODUCTION FIRM "MIKROKHIM", Ukraine (registered address and laboratory of physicochemical analysis and production control; storage of finished products and materials; production site (all stages of the production process); biological analysis laboratory) |
Ukraine |
amendments to registration materials: Type I changes – introduction of additional batch sizes of the finished medicinal product. Proposed wording. Batch size: 40 000 tablets. 120 000 tablets 240 000 tablets |
by
prescription |
UA/17135/01/03 |
|
INTETRIX |
capsules; 10 capsules per blister; 2 blisters per cardboard box |
IPSEN PHARMA |
France |
BEAUFOUR IPSEN INDUSTRIE |
France |
amendments to registration materials: Type I variations - Quality changes. API. Manufacture. Changes in the manufacturing process of the API (minor change in the manufacturing process of the API) - minor change in the manufacturing process of the API tilquinol. The synthesis route and the intermediate product remain unchanged. In the first concentration step, heating under reflux is carried out instead of draining. Before the purification step, a washing step with 50% sulfuric acid and ethanol is proposed (according to the API manufacturer, the purification step existed but was not specified in the dossier materials). In the purification step, sodium lauryl sulfate was replaced with activated carbon. Accordingly, the list of reagents and solvents changes; Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (other changes) - change in the parameter "Description" of the API tilquinol. The description is specified in accordance with the EDQM guidance. The appearance of the API has not changed. (Approved: Pale micro crystalline powder; proposed: Almost white to slightly brown powder); Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) - deletion of the solubility test from the specification of the API tilquinol, since this parameter relates to properties; Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) - deletion of identification by melting point from the specification of the API tilquinol, since an IR spectroscopy method is available and an HPLC method is being introduced; Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) - deletion of identification by the TLC method from the specification of the API tilquinol, since an IR spectroscopy method is available and an HPLC method is being introduced; Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition of a new quality parameter and the corresponding test method to the specification) - addition of identification by the HPLC method to the specification of the API tilquinol; Type I variations - Quality changes. API. Control of the API. Change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition or replacement (except for an active substance of biological or immunological origin) of a specification parameter with the corresponding test method on the basis of safety or quality studies) - changes in the specification parameters of the API tilquinol for the parameter "Purity" due to a change of method from TLC to HPLC. Approved:
absence of any spots other than the spot corresponding to the standard solution; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition of a new quality parameter to the specification and the corresponding test method) – addition to the API specification for tiliquinol of the determination of water by the semi-micro method, since the results of quantitative analyses are given on the anhydrous basis; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of the TLC identification of laurylsulfate from the API specification for tiliquinol laurylsulfate, since an IR spectroscopy method is available that also provides for the determination of laurylsulfate; Type I changes – Quality changes. API. API control. Change in the test methods for the API or for a starting material/intermediate/reagent used in the API manufacturing process (minor changes to approved test methods) – changes to the test method for the API tiliquinol, assay by potentiometric titration (changes in sample preparation); Type I changes – Quality changes. API. Stability. Change in the retest period/shelf life or storage conditions of the API (where the approved dossier has no certificate of suitability to the European Pharmacopoeia that includes a retest period) (retest period/shelf life) – Reduction – change in the retest period of tiliquinol from 4 years to 3 years on the basis of stability testing data in accordance with ICH requirements; Type I changes – Quality changes. Finished medicinal product. (other changes) – change of the dossier format; Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product (minor change to the manufacturing process) – minor change in the manufacture of the finished medicinal product, in particular deletion of sieving of the weighed substances before blending, since sieving is no longer required – the physicochemical characteristics of the ingredients are guaranteed by the manufacturers. Sieving is retained only for tiliquinol laurylsulfate because of its high bulk density. The sieving step after blending of the components and compression before capsule filling is also retained; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the parameters of specifications and/or acceptance limits for an excipient (addition of a new quality parameter to the specification with the corresponding test method) – update of the specification and control methods for the empty capsule shell. Testing will be performed in accordance with an in-house monograph, based on the tests of a French Pharmacopoeia monograph that was in force in the past and has now been withdrawn. In particular, the specification parameter “Lubricants” is added. Test method – gravimetric method in accordance with the French Pharmacopoeia monograph that was in force in the past; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the parameters of specifications and/or acceptance limits for an excipient (addition of a new quality parameter to the specification with the corresponding test method) – Update of the specification and control methods for the empty capsule shell. Testing will be performed in accordance with an in-house monograph, based on the tests of a French Pharmacopoeia monograph that was in force in the past and has now been withdrawn. In particular, the specification parameter “Loss on drying” is added. Test method – in accordance with the Ph. Eur.; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the parameters of specifications and/or acceptance limits for an excipient (addition of a new quality parameter to the specification with the corresponding test method) – Update of the specification and control methods for the empty capsule shell. Testing will be performed in accordance with an in-house monograph, based on the tests of a French Pharmacopoeia monograph that was in force in the past and has now been withdrawn. In particular, the specification parameter “Sulfated ash” is added. Test method – in accordance with the Ph. Eur.; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the parameters of specifications and/or acceptance limits for an excipient (addition of a new quality parameter to the specification with the corresponding test method) – Update of the specification and control methods for the empty capsule shell. Testing will be performed in accordance with an in-house monograph, based on the tests of a French Pharmacopoeia monograph that was in force in the past and has now been withdrawn. In particular, the specification parameter “Disintegration” is added. Test method – in accordance with the Ph. Eur.; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the test methods for an excipient (minor changes to approved test methods) – Minor changes to the capsule test method – azorubine and indigotine by TLC. Changes in sample preparation in order to improve the method; Type I changes – Quality changes. Finished medicinal product. Control of excipients. Change in the test methods for an excipient (other changes to test methods (including replacement or addition)) – change of the test method for sulfur dioxide in capsules from the French Pharmacopoeia method in the monograph “Gelatin” to the method 2.5.29 described in the Ph. Eur. monograph “Gelatin”; Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Change in the batch size (including batch size ranges) of the finished medicinal product (reduction by up to 10 times) – reduction of the batch size of the finished medicinal product from 252 kg (600 000 capsules) to 199,5 kg (475 000 capsules). The new batch size better corresponds to the size of the equipment. Validation of the new batch size has been performed.; Type I changes – Quality changes. Certificate of suitability/CEP to the European Pharmacopoeia/monograph. Changes related to the need to bring the dossier into compliance with a monograph of the SPhU or the European Pharmacopoeia, or another national pharmacopoeia of an EU Member State (change in the specifications related to replacing the requirements of a monograph of the SPhU or another national pharmacopoeia of an EU Member State with the requirements of a monograph of the European Pharmacopoeia) – Bringing the specification and control methods for lactose monohydrate into compliance with the Ph. Eur. monograph; Type I changes – Quality changes. Certificate of suitability/CEP to the European Pharmacopoeia/monograph. Changes related to the need to bring the dossier into compliance with a monograph of the SPhU or the European Pharmacopoeia, or another national pharmacopoeia of an EU Member State (change in the specifications related to replacing the requirements of a monograph of the SPhU or another national pharmacopoeia of an EU Member State with the requirements of a monograph of the European Pharmacopoeia) – Bringing the specification and control methods for maize starch into compliance with the Ph. Eur. monograph; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (addition of a new quality parameter to the specification with the corresponding test method) – Addition of a new parameter to the specification with the corresponding test method: addition of identification of tiliquinol and tilbroquinol by HPLC to the release specification. TLC identification was approved; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (addition of a new quality parameter to the specification with the corresponding test method) – The specification and control methods for the finished medicinal product are supplemented with the quantitative determination of tiliquinol laurylsulfate by titration with a content limit of ±10% in accordance with the method validation data; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (tightening of acceptance limits) – tightening of the limits for the parameter “Average mass” in the registration dossier materials, with a corresponding clarification of the regulation in the specification and control methods. Approved: in the original documents and the test method of the manufacturer's specification: 388 – 452 mg, in the manufacturer's specification approved in Ukraine: 420 mg ± 7,5%; Proposed: 388,5 – 451,5 mg. The change is made in order to state the deviation ± 7,5% more precisely; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (deletion of a minor parameter (e.g., an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the parameter “Heavy metals” from the release specification of the finished medicinal product, since the manufacturing process carries no risk of introducing inorganic impurities into the finished medicinal product; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (deletion of a minor parameter (e.g., an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the “test for absence of toxicity” from the registration dossier materials of section 3.2.P.5.1. (release specification of the finished medicinal product), since the Ph. Eur. and ICH guidelines do not provide for this test for capsules. This test is not included in the approved manufacturer's specification; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (deletion of a minor parameter (e.g., an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the TLC identification of tiliquinol and tilbroquinol from the shelf-life specification of the finished medicinal product, since these tests are not indicative in stability studies; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (deletion of a minor parameter (e.g., an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the identification of laurylsulfate by color reaction from the shelf-life specification of the finished medicinal product, since this test is not indicative in stability studies; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (deletion of a minor parameter (e.g., an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the “Uniformity of mass” test from the shelf-life specification of the finished medicinal product, since this test is not indicative in stability studies. The test is retained in the release specification; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (addition of a new quality parameter to the specification with the corresponding test method) – Introduction of the parameter “Mass variation” with a limit of ≤ 2 % in the shelf-life specification, since this parameter is used to control protection against moisture; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods for the finished medicinal product (minor change to approved test methods) – changes to the test methods for the finished medicinal product, identification of tiliquinol and tilbroquinol by TLC (changes in sample preparation and deletion of spraying, since the spots are detected without it); Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods for the finished medicinal product (minor change to approved test methods) – changes to the method for identification of laurylsulfate by color reaction, in particular replacement of the reagent triphenyltetrazolium bromide with triphenyltetrazolium chloride; Type I changes – Quality changes. API. Manufacture. Changes in the API manufacturing process (minor change in the API manufacturing process) – Minor change in the manufacturing process of the API tilbroquinol. The synthesis route and the intermediate remain unchanged. In the first concentration step, heating under reflux is carried out instead of draining. Before the purification step, a washing step with 50% sulfuric acid and ethanol is proposed (according to data from the company Expansia, the purification step existed but was not specified in the dossier materials). In the purification step, sodium laurylsulfate is replaced with activated carbon. The reaction mixture is heated before the addition of bromide. Excess bromide is reduced by adding sodium thiosulfate. A distillation step is provided for the removal of ethanol. The list of reagents and solvents changes accordingly; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (other changes) – change in the parameter “Description” of the API tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of the solubility test from the API specification for tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)); deletion of identification by melting point from the API specification for tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of TLC identification from the API specification for tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition of a new quality parameter to the specification and the corresponding test method) – addition of HPLC identification to the API specification for tilbroquinol. The test is performed simultaneously with the test for the parameter “Related impurities”; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition or replacement (except for an active substance of biological or immunological origin) of a specification parameter with the corresponding test method as a result of safety or quality studies) – changes to the specification parameters of the API tilbroquinol regarding the determination of impurities due to the change of method from TLC to HPLC. Approved: the principal spot obtained from the test solution corresponds in size, color and position to the spot obtained from the standard solution; if a tiliquinol spot is present, its intensity is not greater than in the standard solution – 0,5%; proposed: tiliquinol – 0,5%, any impurity 0,10%; total 1,0%; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition of a new quality parameter to the specification and the corresponding test method) – addition to the API specification for tilbroquinol of the determination of water by the semi-micro method, since the results of quantitative analyses are given on the anhydrous basis; Type I changes – Quality changes. API. API control. Change in the test methods for the API or for a starting material/intermediate/reagent used in the API manufacturing process (minor changes to approved test methods) – changes to the method for the quantitative determination of the API tilbroquinol (changes in sample preparation for the potentiometric titration method); Type I changes – Quality changes. API. Stability. Change in the retest period/shelf life or storage conditions of the API (where the approved dossier has no certificate of suitability to the European Pharmacopoeia that includes a retest period) (retest period/shelf life) – Reduction – change in the retest period of tilbroquinol from 4 years to 3 years on the basis of available stability testing data in accordance with ICH requirements; Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of specifications and/or acceptance limits of the finished medicinal product (addition of a new quality parameter to the specification with the corresponding test method) – introduction of the parameter “Dissolution” into the shelf-life specification of the finished medicinal product; Type I changes – Quality changes. API. Manufacture. Changes in the API manufacturing process (minor change in the API manufacturing process) – Minor change in the manufacturing process of the API tiliquinol laurylsulfate. The synthesis route and the intermediate remain unchanged. In the first concentration step, heating under reflux is carried out instead of draining. Before the purification step, a washing step with 50% sulfuric acid and ethanol is proposed (according to data from the company Expansia, the purification step existed but was not specified in the dossier materials). In the purification step, sodium laurylsulfate is replaced with activated carbon. The list of reagents and solvents changes accordingly; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (other changes) – change in the parameter “Description” of the API tiliquinol laurylsulfate. Approved: Yellow micro crystalline powder with an unpleasant taste; Proposed: Yellow powder; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of the solubility test from the API specification for tiliquinol laurylsulfate; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – Deletion of the test for halides from the API specification for tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of the test for free halogens from the API specification for tilbroquinol; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (deletion of a minor quality parameter (e.g., deletion of an obsolete parameter)) – deletion of the identification of laurylsulfate by color reaction from the API specification for tiliquinol laurylsulfate, since an IR spectroscopy method is used; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (addition of a new quality parameter to the specification and the corresponding test method) – addition of HPLC identification to the API specification for tiliquinol laurylsulfate. The test is performed simultaneously with the test for the parameter “Related impurities”; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (tightening of acceptance limits specified in the specification) – tightening of the limits in the API specification for tiliquinol laurylsulfate for the parameter “Water content” from 2,0% to 1,0%; Type I changes – Quality changes. API. API control. Change in the parameters of specifications and/or acceptance limits specified in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process (tightening of acceptance limits specified in the specification) – Tightening of the limits in the API specification for tiliquinol laurylsulfate for the parameter “assay”; Type I changes – Quality changes. API. API control. Change in the test methods for the API or for a starting material/intermediate/reagent used in the API manufacturing process (other changes to test methods (including replacement or addition) for the API or a starting material/intermediate) – change in the potentiometric titration method for the API tiliquinol laurylsulfate (changes in sample preparation); Type I changes – Quality changes. API. Stability. Change in the retest period/shelf life or storage conditions of the API (where the approved dossier has no certificate of suitability to the European Pharmacopoeia that includes a retest period) (retest period/shelf life) – Reduction – change in the retest period of tiliquinol laurylsulfate from 4 years to 3 years on the basis of available stability testing data in accordance with ICH requirements; Type I changes – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (change in the storage conditions of the finished medicinal product or after dilution/reconstitution) – change in the storage conditions of the finished medicinal product (implementation of the changes within 3 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer's site (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in API manufacture (if specified in the medicinal product dossier) where there is no certificate of suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier) – change of the name of the manufacturer of the API tiliquinol; Type I changes – Administrative changes. Change in the name and/or address of the manufacturer's site (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in API manufacture (if specified in the medicinal product dossier) where there is no certificate of suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier) – change of the name of the manufacturer of the API tilbroquinol; Type I changes – Administrative changes. Change in the name and/or address of the manufacturer's site (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in API manufacture (if specified in the medicinal product dossier) where there is no certificate of suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier) – change of the name of the manufacturer of the API tiliquinol laurylsulfate; Type I changes – Administrative changes. Change in the name of the API or of an excipient – change of the API name. Approved: Tiliquinol-N-Dodecyl sulfates; Proposed: Tiliquinol laurylsulfate . The INN is stated in accordance with the manufacturer's documentation. Implementation of the changes within 3 months after approval; Type I changes – Changes concerning safety/efficacy and pharmacovigilance (other changes) – change of the primary and secondary packaging of the finished medicinal product. Update of the text in accordance with the package leaflet. Removal of the text in Russian.
Implementation of changes within 3 months after approval; Type I changes – Changes related to safety/efficacy and pharmacovigilance – changes were made to the package leaflet of the medicinal product in the section “Adverse reactions” (Implementation of changes within 3 months after approval); Type I changes – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the parameters of the specifications and/or acceptance limits of the finished medicinal product (deletion of a non-significant parameter (for example, an obsolete parameter such as odor and taste, or identification of colorants or flavorings)) – Deletion of the “Disintegration” test of the finished medicinal product from the shelf-life specification. The same package of changes introduces the “Dissolution” test into the shelf-life specification; Type I changes – Quality changes. API. Control of the API. Change in the parameters of the specifications and/or acceptance limits set in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API (addition or replacement (except for an active substance of biological or immunological origin) of a specification parameter with the corresponding test method based on the results of safety or quality studies) – introduction into the specification of the API tilquinol lauryl sulfate of the parameter “Purity by HPLC” with the corresponding test method in accordance with the requirements of the general EP monograph “Substances for pharmaceutical use” |
by prescription |
UA/4724/02/01 |
|
INCENA® |
oral drops, 20 mL or 50 mL or 100 mL in a dropper bottle; 1 dropper bottle in a cardboard package |
Richard Bittner AG |
Austria |
Richard Bittner AG |
Austria |
amendments to registration materials: type I variations – changes in the API manufacturing process – introduction of an additional supplier of herbal raw material for production of the active substance Pulsatilla; place of cultivation Loitze, Germany; type II variations – change of the manufacturer of a starting material/intermediate/reagent used in the API manufacturing process, or change of the API manufacturer (including, where relevant, quality control sites) – addition of the manufacturer Richard Bittner AG, Austria, for the mother tincture of the active substance Pulsatilla |
without
prescription |
UA/8414/01/01 |
|
YOHIMBINE HYDROCHLORIDE |
tablets of 5 mg, 50 tablets in a plastic container; 1 container in a cardboard box; 10 tablets in a blister; 5 blisters in a cardboard box; 50 tablets in plastic containers |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the applicant’s address; Type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the site where quality control is performed (activity for which the manufacturer/importer is responsible, including batch release) – clarification of the address of the manufacturer, Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine, without a change of the manufacturing site (implementation of changes within 6 months after approval) |
by
prescription |
UA/3714/01/01 |
|
CADUET 10/10 |
film-coated tablets, 10 mg/10 mg, 10 tablets in a blister; 3 blisters in a cardboard box |
PFIZER INC. |
USA |
Pfizer Manufacturing Deutschland GmbH |
Germany |
amendments to registration materials:
type I variations – changes to the Package Insert for medical use of the medicinal product in the sections “Pharmacological properties”, “Contraindications”, “Interaction with other medicinal products and other forms of interaction”, “Precautions for use”, “Method of administration and doses”; use during pregnancy or breastfeeding”, “Adverse reactions”. Implementation of the changes within 3 months after approval |
by prescription |
UA/5635/01/01 |
|
CADUET 5/10 |
film-coated tablets, 5 mg/10 mg, 10 tablets in a blister; 3 blisters in a cardboard box |
PFIZER INC. |
USA |
Pfizer Manufacturing Deutschland GmbH |
Germany |
amendments to registration materials:
type I variations – changes to the Package Insert for medical use of the medicinal product in the sections “Pharmacological properties”, “Contraindications”, “Interaction with other medicinal products and other forms of interaction”, “Precautions for use”, “Method of administration and doses”; use during pregnancy or breastfeeding”, “Adverse reactions”. Implementation of the changes within 3 months after approval |
by prescription |
UA/5635/01/02 |
|
CANCIDAS® |
lyophilizate for solution for infusion, 50 mg, 1 vial of powder per cardboard box |
Merck Sharp & Dohme IDEA GmbH |
Switzerland |
Laboratoires Merck Sharp & Dohme Chibret, France (full-cycle manufacturing); Merck Sharp & Dohme B.V., the Netherlands (secondary packaging, batch release) |
France/ Netherlands |
amendments to registration materials: Type I variation – replacement of the source of an excipient or reagent that poses a risk of transmission of TSE agents – addition of a supplier of bone char used as a filter in the production of sucrose (an excipient in the composition of the medicinal product) |
by
prescription |
UA/2841/01/01 |
|
CANCIDAS® |
lyophilizate for solution for infusion, 70 mg; 1 vial with powder per cardboard box |
Merck Sharp & Dohme IDEA GmbH |
Switzerland |
Laboratoires Merck Sharp & Dohme Chibret, France (full-cycle manufacturing); Merck Sharp & Dohme B.V., the Netherlands (secondary packaging, batch release) |
France/ Netherlands |
amendments to registration materials: Type I variation – replacement of the source of an excipient or reagent that poses a risk of transmission of TSE agents – addition of a supplier of bone char used as a filter in the production of sucrose (an excipient in the composition of the medicinal product) |
by
prescription |
UA/2841/01/02 |
|
CARBOPLATIN “EBEWE” |
concentrate for solution for infusion, 10 mg/mL in 5 mL (50 mg), or in 15 mL (150 mg), or in 45 mL (450 mg), or in 60 mL (600 mg) in a vial; 1 vial in a carton |
EBEWE Pharma Ges.m.b.H. Nfg. KG |
Austria |
EBEWE Pharma Ges.m.b.H. Nfg. KG |
Austria |
amendments to registration materials: Type II variations - Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (change in the weight/volume of the contents of the container of a multidose sterile medicinal product (or single-dose, partial use) and of a multidose medicinal product of biological/immunological origin for parenteral use) - introduction of an additional pack of 600 mg/60 ml in a vial; 1 vial per carton, without a change of the primary packaging material, with corresponding changes in the section "Packaging" and in the batch release specification, item "Extractable volume." Changes have been made to the package leaflet in the section "Packaging," and, as a consequence, corresponding changes to the labeling text of the medicinal product packaging (implementation of changes within 6 months after approval) |
by prescription |
UA/4960/01/01 |
|
KASARK ® HD |
tablets, 32 mg/25 mg, 10 tablets per blister, 1, 3, 10 blisters per box |
ORGANOSYN LIFESCIENCES (FZC) |
UAE |
Evertogen Life Sciences Limited |
India |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (reduction of the shelf life of the finished medicinal product) – For the commercial packaging. Reduction of the shelf life of the finished medicinal product KASARK ® HD, tablets, 32 mg/25 mg. Approved:
Shelf life: Two years. Proposed: Shelf life: 1,5 years |
by
prescription |
UA/12282/01/01 |
|
KASARK ® HD |
tablets, 32 mg/25 mg in bulk: 2500 tablets in a double bag; 1 bag in a cardboard box |
ORGANOSYN LIFESCIENCES (FZC) |
UAE |
Evertogen Life Sciences Limited |
India |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (reduction of the shelf life of the finished medicinal product) – For the commercial packaging. Reduction of the shelf life of the finished medicinal product KASARK ® HD, tablets, 32 mg/25 mg. Approved:
Shelf life: Two years. Proposed: Shelf life: 1,5 years |
– |
UA/12283/01/01 |
|
CAFFETIN® LADY |
film-coated tablets, 200 mg each, 10 tablets per blister; 1 or 2 blisters in a box |
Abbott Laboratories GmbH |
Germany |
ALKALOID AD Skopje, Macedonia, former |
Yugoslav Republic |
amendments to registration materials:
Type I changes – change in the parameters of the specifications and/or acceptance limits of the finished medicinal product – tightening of the acceptance limits in the specification in connection with optimization of the test method, test Dissolution; changes to the Description section with a more precise definition of color, without a change of color; change in the parameters of the finished medicinal product specification, test Related substances, replacement of the name in accordance with the EP monograph “Ibuprofen” from EP “2-(4-Isobutylphenyl) propionic acid – not more than 0,2%” to “impurity J – not more than 0,2%”, tightening of the acceptance criteria; Type I changes – change in the test methods of the finished medicinal product – minor change to approved test methods for the Description section, change in the description of the test method; test Uniformity of dosage units, update of the test method in connection with bringing into line with EP requirements.2.9.40; change in the specification parameters, test Microbiological purity, in connection with bringing into line with EP requirements; Type I changes – change in the test methods of the finished medicinal product – changes in test methods, test Identification – optimization of the HPLC test method; test Related substances – optimization of the HPLC test method (change of the method name from “Related substances” to “Related impurities and degradation products”); test Dissolution – optimization of the test method (absorption spectrophotometry method); test Related substances – optimization of the HPLC test method |
Without prescription |
UA/9605/01/01 |
|
KETONAL® |
suppositories of 100 mg, 6 suppositories per strip; 2 strips per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceuticals d.d., Slovenia (batch control/testing, batch release); S.C. Sandoz S.R.L., Romania (batch control/testing); Sandoz Ilac Sanayi ve Ticaret A.S., Turkey (bulk manufacturing, packaging) |
Slovenia/Romania/Turkey |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David John Lewis, B. Sc(Hons), Ph. D./ David Jones Lewis. Change of the contact details of the qualified person responsible for pharmacovigilance |
by prescription |
UA/8325/06/01 |
|
KETONAL® |
solution for injection, 100 mg/2 mL, 2 mL in an ampoule; 5 ampoules in a blister; 2 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d. |
Slovenia |
amendments to registration materials:
Type I variations – variations concerning safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David John Lewis, B. Sc(Hons), Ph. D. Change of contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by prescription |
UA/8325/01/01 |
|
KETONAL® |
cream 5%, 30 g in a tube; 1 tube in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH |
Germany |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David John Lewis, B. Sc(Hons), Ph. D. / David Jones Lewis. Change of the contact details of the qualified person responsible for pharmacovigilance |
by prescription |
UA/8325/07/01 |
|
KETONAL® DUO |
hard modified-release capsules, 150 mg each, 10 capsules per blister; 2 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (full-cycle manufacturing; packaging) |
Slovenia |
amendments to registration materials: Type I variations – changes concerning safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Viktorovych Orlov. Change of the contact details of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/8325/03/02 |
|
KETOROL GEL |
gel 2%, 30 g in a tube; 1 tube in a box |
Dr. Reddy's Laboratories Ltd |
India |
Dr. Reddy’s Laboratories Ltd (Manufacturing Site – VI) |
India |
amendments to the registration materials: Type I variation – change in the batch size (including batch size range) of the finished medicinal product (increase up to 10 times compared to the approved size), introduction of an additional batch size of 750 kg for the finished medicinal product to the already approved batch size of 250 kg |
without
prescription |
UA/2566/03/01 |
|
AMINOCAPROIC ACID |
solution for infusion 5 %, 100 ml in bottles |
Private Joint-Stock Company “Infuzia” |
Ukraine |
Private Joint-Stock Company “Infuzia” |
Ukraine |
amendments to registration materials: Type I variation – change in the parameters of specifications and/or acceptable limits defined in the specifications for the API, or for the starting/intermediate material/reagent used in the API manufacturing process (other changes); consequential change: deletion from the parameter "Identification" of the API specification of the subsection "Second identification" with the corresponding test method |
by
prescription |
UA/4531/01/01 |
|
CLOPIDAL® |
film-coated tablets, 75 mg each, 10 tablets per blister; 3 blisters in a cardboard box |
ALKALOID AD Skopje |
Republic of Macedonia |
ALKALOID AD Skopje |
Republic of Macedonia |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data), extension of the shelf life of the finished medicinal product.
Approved: 1 year. Proposed: 2 years. Type I variations – Quality variations. Certificate of suitability/TSE certificate of suitability to the European Pharmacopoeia/monograph. Submission of a new or updated certificate of suitability or deletion of a certificate of suitability to the European Pharmacopoeia: for an API; for a starting material/reagent/intermediate used in the manufacture of an API; for an excipient (certificate of suitability to the European Pharmacopoeia) – Updated certificate from an already approved manufacturer – submission of an updated Certificate R1-CEP 2011-049-Rev 01 from the already approved manufacturer MSN Laboratories Private Limited. Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for an API, intermediate or finished medicinal product, packaging sites, a manufacturer responsible for batch release, a batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) of a manufacturing site for the API Clopidogrel bisulfate Aurobindo Pharma Limited, India. |
by prescription |
UA/13334/01/01 |
|
KODESAN® IC |
tablets, 10 tablets per blister; 1 blister per cardboard pack |
Company with Additional Liability “INTERCHEM” |
Ukraine |
Company with Additional Liability “INTERCHEM” |
Ukraine |
amendments to registration materials: Type I variations - deletion of the site at the address Ukraine, 65080, Odesa Oblast, Odesa, Lustdorfska Road, building 86, where finished products were stored, and deletion of information on the location of the legal entity in the registration materials for the active substance Licorice root. The changes are made in connection with the renewal of the valid manufacturing license; Type I variations - replacement of the site where batch control testing is performed: from the sites at the addresses Ukraine, 65080, Odesa Oblast, Odesa, Lustdorfska Road, building 86 and Ukraine, 65025, Odesa, 21th km of Starokyivska Road, 23 to the site at the address Ukraine, 65025, Odesa, 21th km of Starokyivska Road, 40-A in the registration materials for the active substance Licorice root; the changes are made in connection with the renewal of the valid manufacturing license; Type I variations - addition of a manufacturing area (within the approved manufacturing site of PrAC "INTERKHIM") at the address Ukraine, 65025, Odesa, 21th km of Starokyivska Road, 40-A, where manufacture, primary and secondary packaging, and storage of finished products, raw materials and materials are carried out, in the registration materials for the active substance Licorice root; the changes are made in order to optimize the manufacturing process and in connection with the renewal of the valid manufacturing license; Type I variations - replacement of the manufacturers of the active substance codeine phosphate included in the composition of the medicinal product - introduction of the manufacturer Macfarlan Smith Limited (manufacturing site at the address Three Trees Road, Newbie United Kingdom-DG 125QH Annan, Scotland, UK) and deletion of the manufacturer Alkoloida Chemical Company Zrt., Hungary, which hold a certificate of suitability of the EP; proposed: manufacturers of the active substance codeine phosphate hemihydrate: Macfarlan Smith Limited, United Kingdom (manufacturing site at the address 10, Wheatfield Road, Edinburgh, Scotland, EH 11 2QA) CEP R1-CEP 1999-053-Rev 01 and Macfarlan Smith Limited, United Kingdom (manufacturing site at the address Three Trees Road, Newbie United Kingdom-DG 125QH Annan, Scotland, UK) CEP R0-CEP 2016-295-Rev 02); concomitant change: changes in the specification and control methods of the API: change of the limits for the test "Residual solvents" by deleting the limits of the test for the manufacturer Alkoloida Chemical Company Zrt., Hungary and adding the limits of the test for the Annan site of the manufacturer Macfarlan Smith Limited; deletion of the test "N,N-dimethylaniline" for the manufacturer Alkoloida Chemical Company Zrt., Hungary; changes in the sections packaging, labeling, shelf life; Type I variations - quality changes. Finished medicinal product. Control of the finished medicinal product; concomitant change - clarification of the wording of the limits for the test "Uniformity of dosage units" in the finished product specification and in the specification and quality control methods for the intermediate product "Bulk tablets" (as a concomitant change) |
by
prescription |
UA/8687/01/01 |
|
COLPOTROPHINE |
soft vaginal capsules, 10 mg each, 10 capsules per blister; 1 blisters per cardboard box |
LLC “Teva Ukraine” |
Ukraine |
Capsugel Ploermel, France (bulk product manufacture, batch control); Confarma France, France (batch control (microbiological testing only)); Lafal Industrie, France (primary and secondary packaging, batch release); Teva Pharmaceuticals Europe B.V., the Netherlands (batch release) |
France/ Netherlands |
amendments to registration materials:
Type I variation – introduction of a manufacturer of the API promestriene; proposed: MONACHEM, Monako Sicor de Mexico S.A. de C.V., Mexico
Implementation of the changes within 6 months after approval; Type I variations – changes in the API manufacturing process (minor change in the API manufacturing process); Type I variations – change of the API storage conditions from “not above 30 °C” to “in accordance with the long-term stability study conditions of 25 °C/60 % RH”, due to harmonization of API storage conditions for different storage conditions; Type I variations – submission of an updated European Pharmacopoeia certificate of suitability No. R2-CEP 1995-017 Rev 04 from the approved supplier BAYER AG, Germany, for the starting material estradiol hemihydrate used in the synthesis of the API promestriene; Type I variations – submission of an updated European Pharmacopoeia certificate of suitability No. R1-CEP 2009-241 Rev 02 from the approved supplier VALDEPHARM, France, for the starting material estradiol hemihydrate used in the synthesis of the API promestriene |
by prescription |
UA/3481/03/01 |
|
COMBISPASM® GASTROCOMFORT |
film-coated tablets, 10 tablets in a blister; 1 or 2 blisters in a cardboard pack |
Organosyn Life Sciences Pvt. Ltd. |
India |
Evertogen Life Sciences Limited |
India |
amendments to registration materials: Type I variations - change in batch size (including batch size ranges) of the finished medicinal product: increase in batch size; proposed: 650 000 tablets; Type I variations - changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product - changes in the manufacturing process of the finished medicinal product at the stages of sieving, granulation, drying of wet granules, milling, additional sieving, blending, compression, and film coating of tablets; Type II variations - change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the API, or change of the manufacturer (including, where necessary, the quality control site) of the API - introduction of an additional API manufacturer (dicycloverine hydrochloride) |
without
prescription |
UA/15710/01/01 |
|
COMBISPASM® GASTROCOMFORT |
film-coated tablets, in bulk: 5000 tablets in double polyethylene bags |
Organosyn Life Sciences Pvt. Ltd. |
India |
Evertogen Life Sciences Limited |
India |
amendments to registration materials: Type I variations - change in batch size (including batch size ranges) of the finished medicinal product: increase in batch size; proposed: 650 000 tablets; Type I variations - changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product - changes in the manufacturing process of the finished medicinal product at the stages of sieving, granulation, drying of wet granules, milling, additional sieving, blending, compression, and film coating of tablets; Type II variations - change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the API, or change of the manufacturer (including, where necessary, the quality control site) of the API - introduction of an additional API manufacturer (dicycloverine hydrochloride) |
– |
UA/15711/01/01 |
|
COPAXONE 40 |
solution for injection, 40 mg/mL, 1 mL of solution in a pre-filled syringe; 1 syringe in a blister; 12 syringes in a carton |
Teva Pharmaceutical Industries Ltd. |
Israel |
Abic Ltd., Israel (Batch control (biological testing only)); Asia Chemical Industries Ltd., Israel (Batch control (analytical testing and stability studies)); TEVA Pharmaceutical Works Private Ltd. Co., Hungary (Batch control (biological testing only)); Norton Healthcare Limited T/A IVAX Pharmaceuticals UK, United Kingdom (Full-cycle manufacture); Plantex Ltd., Israel (Batch control (analytical testing and stability studies)); Teva Pharmaceutical Industries Ltd., Israel (Full-cycle manufacture); Teva Pharmaceutical Industries Ltd., Israel (Batch control (microbiological testing only)); Pharmachemie B.V., Netherlands (Batch control (full testing, including sterility and bacterial endotoxins, but excluding biological testing)) |
Israel/ Hungary/ United Kingdom/ Netherlands |
amendments to registration materials:
Type I variation – change in the test methods of the API or of a starting material/intermediate/reagent used in the API manufacturing process – minor changes to approved test methods for materials used in the API manufacturing process: optimization of the analytical procedure for the titration of monomers |
by prescription |
UA/6307/01/02 |
|
COPAXONE 40 |
solution for injection, 40 mg/mL, 1 mL of solution in a pre-filled syringe; 1 syringe in a blister; 12 syringes in a carton |
Teva Pharmaceutical Industries Ltd |
Israel |
Abic Ltd., Israel (Batch control (biological testing only)); Asia Chemical Industries Ltd., Israel (Batch control (analytical testing and stability studies)); TEVA Pharmaceutical Works Private Ltd. Co., Hungary (Batch control (biological testing only)); Norton Healthcare Limited T/A IVAX Pharmaceuticals UK, United Kingdom (Full-cycle manufacture); Plantex Ltd., Israel (Batch control (analytical testing and stability studies)); Teva Pharmaceutical Industries Ltd., Israel (Full-cycle manufacture); Teva Pharmaceutical Industries Ltd., Israel (Batch control (microbiological testing only)); Pharmachemie B.V., Netherlands (Batch control (full testing, including sterility and bacterial endotoxins, but excluding biological testing)) |
Israel/ Hungary/ United Kingdom/ Netherlands |
amendments to registration materials:
a technical error in the instructions for medical use was corrected in the sections “Use during pregnancy or breastfeeding”, “Adverse reactions”. Implementation of changes within 3 months after approval |
by prescription |
UA/6307/01/02 |
|
CORVALTAB |
tablets; 10 tablets in blisters; 10 tablets per blister; 2 or 10 blisters in a cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460) (Implementation period for the changes – 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release) – the change in the spelling of the address of the manufacturing site of the finished medicinal product of the company LLC “Pharma Start”, without a change in the actual place of activity, is made in connection with the Decision of the Kyiv City Council of 10 November 2016 No. 315/1319 on renaming boulevards, streets and squares and naming public gardens in the city of Kyiv (Implementation period for the changes – 6 months after approval); Type I changes – Changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – Change in the contact details of the qualified person responsible for pharmacovigilance. Change in the location where the main pharmacovigilance activities are performed. Change in the location of the master file |
without prescription – No. 10 and No. 10x2; by prescription – No. 10x10 |
UA/1028/01/01 |
|
CORVALTAB |
tablets; in bulk: 7 kg of tablets in a polyethylene bag; 1 bag per container |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460) (Implementation period for the changes – 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release) – the change in the spelling of the address of the manufacturing site of the finished medicinal product of the company LLC “Pharma Start”, without a change in the actual place of activity, is made in connection with the Decision of the Kyiv City Council of 10 November 2016 No. 315/1319 on renaming boulevards, streets and squares and naming public gardens in the city of Kyiv (Implementation period for the changes – 6 months after approval); Type I changes – Changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – Change in the contact details of the qualified person responsible for pharmacovigilance. Change in the location where the main pharmacovigilance activities are performed. Change in the location of the master file |
– |
UA/3760/01/01 |
|
XEFOCAM® |
powder for solution for injection, 8 mg; 5 vials of powder per cardboard box |
Takeda Austria GmbH |
Austria |
secondary packaging and batch release:
Takeda Austria GmbH, Austria;
manufacture of bulk products, primary packaging:
Wasserburger Arzneimittelwerk GmbH, Germany |
Austria/
Germany |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the place of business of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites. (activity for which the manufacturer/importer is responsible, including batch release) – clarification of the address of the manufacturer Takeda Austria GmbH, Austria (Implementation of changes within 6 months after approval) |
by prescription |
UA/2593/02/01 |
|
LEVITRA® ODT |
dispersible tablets, 10 mg each, 4 tablets per blister, 1 blister per cardboard pack |
Bayer AG |
Germany |
Bayer AG |
Germany |
amendments to registration materials: Type I variations - changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for conducting pharmacovigilance in Ukraine, if different from the person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) - change of the person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of the contact details of the person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the location of the master file |
by
prescription |
UA/0226/02/01 |
|
LEVOFLOCIN 250 |
film-coated tablets, 250 mg each, 5 tablets per blister; 1 blister in a cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: Type I variations – change of the address of the manufacturing site of the manufacturer of the API levofloxacin hemihydrate, Neuland Laboratories limited, India; Type I variations – changes in the API manufacturing process (minor change in the API manufacturing process); concomitant change – optimization of the manufacturing process of the API levofloxacin hemihydrate manufactured by Neuland Laboratories limited, India, by reducing the production cycle time and eliminating the use of environmentally hazardous solvents as a result of removing the organic solvents pyridine, tetrahydrofuran and dichloromethane from the manufacturing process; these solvents are removed from the API specification; Type I variations – introduction of the Unit-II site in addition to the approved Unit-I/Site-I site; the proposed site is an integral part of Neuland Laboratories; Type II variations – submission of an updated master file for the API levofloxacin hemihydrate from the approved manufacturer Neuland Laboratories Limited Version: NLL/LF/EU-AP/001/00/Nov, 2017, and consequently a change in the specification of the API levofloxacin hemihydrate of the finished medicinal product manufacturer for the parameter “Residual organic solvents” |
by
prescription |
UA/2397/01/01 |
|
LEVOFLOCIN 500 |
film-coated tablets, 500 mg each, 5 tablets per blister; 1 blister in a cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: Type I variations – change of the address of the manufacturing site of the manufacturer of the API levofloxacin hemihydrate, Neuland Laboratories limited, India; Type I variations – changes in the API manufacturing process (minor change in the API manufacturing process); concomitant change – optimization of the manufacturing process of the API levofloxacin hemihydrate manufactured by Neuland Laboratories limited, India, by reducing the production cycle time and eliminating the use of environmentally hazardous solvents as a result of removing the organic solvents pyridine, tetrahydrofuran and dichloromethane from the manufacturing process; these solvents are removed from the API specification; Type I variations – introduction of the Unit-II site in addition to the approved Unit-I/Site-I site; the proposed site is an integral part of Neuland Laboratories; Type II variations – submission of an updated master file for the API levofloxacin hemihydrate from the approved manufacturer Neuland Laboratories Limited Version: NLL/LF/EU-AP/001/00/Nov, 2017, and consequently a change in the specification of the API levofloxacin hemihydrate of the finished medicinal product manufacturer for the parameter “Residual organic solvents” |
by
prescription |
UA/2397/01/02 |
|
LENALIDOMIDE-VISTA |
hard capsules of 2,5 mg, 7 capsules per blister, 3 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/01 |
|
LENALIDOMIDE-VISTA |
hard capsules of 5 mg, 7 capsules per blister, 3 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/02 |
|
LENALIDOMIDE-VISTA |
hard capsules of 7,5 mg, 7 capsules per blister, 3 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/03 |
|
LENALIDOMIDE-VISTA |
hard capsules of 10 mg, 3 capsules per blister, 7 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/04 |
|
LENALIDOMIDE-VISTA |
hard capsules of 15 mg, 3 capsules per blister, 7 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/05 |
|
LENALIDOMIDE-VISTA |
hard capsules of 20 mg, 3 capsules per blister, 7 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/06 |
|
LENALIDOMIDE-VISTA |
hard capsules of 25 mg, 3 capsules per blister, 7 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Synthon Hispania, S.L., Spain (site responsible for packaging, quality control, batch release); Synthon Chile Ltda., Chile (site responsible for manufacturing, packaging, quality control); Pharmadox Healthcare Ltd., Malta (site responsible for quality control) |
Spain/ Chile/ Malta |
amendments to registration materials:
technical error in the package leaflet of the medicinal product in the section “Adverse reactions” |
by prescription |
UA/17466/01/07 |
|
LYSI SANDOZ® |
tablets of 5 mg, 10 tablets per blister; 3 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (in bulk manufacturing, testing); Salutas Pharma GmbH, Germany (full-cycle manufacturing) |
Slovenia/ Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10603/01/01 |
|
LYSI SANDOZ® |
tablets of 10 mg, 10 tablets per blister; 3 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (in bulk manufacturing, testing); Salutas Pharma GmbH, Germany (full-cycle manufacturing) |
Slovenia/ Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10603/01/02 |
|
LYSI SANDOZ® |
tablets of 20 mg, 10 tablets per blister; 3 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (in bulk manufacturing, testing); Salutas Pharma GmbH, Germany (full-cycle manufacturing) |
Slovenia/ Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10603/01/03 |
|
LYZOLID-600 |
coated tablets, 600 mg, 4 or 10 tablets in a strip; 1 strip in a carton box |
Glenmark Pharmaceuticals Ltd. |
India |
Glenmark Pharmaceuticals Ltd. |
India |
amendments to registration materials: Type I variations – change of the address of the linezolid API manufacturer, without a change of manufacturing site |
by
prescription |
UA/10410/02/01 |
|
LINEZOLID |
solution for infusion, 2 mg/ml, 300 ml per bottle; 1 bottle per pack |
JSC “Halychpharm” |
Ukraine |
PJSC “Halychpharm” |
Ukraine |
amendments to registration materials:
type I variations – changes to the instructions for medical use of the medicinal product in the section “Method of administration and doses”, namely, the information on the need to perform a skin test was removed. Implementation of the changes within 6 months after approval |
by prescription |
UA/11948/01/01 |
|
LINEX BABY® |
powder for oral suspension, 1 000 000 000 CFU/sachet of 1,5 g in a sachet; 10 or 20 sachets in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (bulk manufacturing, primary and secondary packaging); Lek Pharmaceutical Company d.d., Slovenia (batch control); Lek Pharmaceutical Company d.d., Slovenia (batch control and release); MARIFARM, manufacturing and services d.o.o., Slovenia (secondary packaging) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/14576/01/01 |
|
LINEX FORTE® |
hard capsules, 7 capsules per blister, 1 or 2, or 4 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (batch release); Lek Pharmaceutical Company d.d., Slovenia (bulk manufacture, packaging) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/14763/01/01 |
|
LINEX® |
hard capsules, 32 capsules per vial; 1 vial per cardboard box; 8 capsules per blister; 2 or 4 or 6 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (bulk manufacture, packaging; batch release) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
without
prescription |
UA/14267/01/01 |
|
LIPRAZID 10 |
tablets, 10 tablets in a blister; 3 blisters in a cardboard pack; 60 or 90 tablets in a container; 1 container in a cardboard pack |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant”, Ukraine (full-cycle manufacture); Limited Liability Company “AGROFARM”, Ukraine (manufacture, packaging, batch release); Limited Liability Company “Natur+”, Ukraine (batch control) |
Ukraine |
amendments to registration materials:
Type I variations – changes to the instructions for medical use in the sections: "Pharmacological properties," "Special warnings and precautions for use," "Adverse reactions" in accordance with updated safety information on the active substance. Implementation of the changes within 3 months after approval |
by prescription |
UA/6916/01/01 |
|
LIPRAZID 20 |
tablets, 10 tablets in a blister; 3 blisters in a cardboard pack; 60 or 90 tablets in a container; 1 container in a cardboard pack |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant”, Ukraine (full-cycle manufacture); Limited Liability Company “AGROFARM”, Ukraine (manufacture, packaging, batch release); Limited Liability Company “Natur+”, Ukraine (batch control) |
Ukraine |
amendments to registration materials:
Type I variations – changes to the instructions for medical use in the sections: "Pharmacological properties," "Special warnings and precautions for use," "Adverse reactions" in accordance with updated safety information on the active substance. Implementation of the changes within 3 months after approval |
by prescription |
UA/6917/01/01 |
|
LOGEST® |
film-coated tablets, 21 tablet per blister with a calendar scale; 1 blister per pack |
Bayer AG |
Germany |
Bayer AG, Germany (primary and secondary packaging, batch release); Bayer Weimar GmbH & Co. KG, Germany (manufacture of in-bulk product, batch control); Delpharm Lille S.A.S., France (full-cycle manufacture) |
Germany/ France |
amendments to registration materials: Type I variations - changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for conducting pharmacovigilance in Ukraine, if different from the person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) - change of the person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of the contact details of the person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the location of the master file |
by
prescription |
UA/4859/01/01 |
|
LORINDEN® C |
ointment, 15 g in a tube; 1 tube in a box |
LLC “VALEANT PHARMACEUTICALS” |
Ukraine |
Jelfa Pharmaceutical Plant JSC |
Poland |
amendments to registration materials: technical error in the labeling text of the primary packaging |
by
prescription |
UA/1718/01/01 |
|
LOSEPRAZOL® |
capsules of 20 mg, 7 capsules per blister; 2 or 4 blisters per cardboard box |
PRO.MED.CS Praha a.s. |
Czech Republic |
PRO.MED.CS Praha a.s. |
Czech Republic |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Dmytro Serhiiovych Savchenko. Change of the contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/7767/01/01 |
|
LUCETAM® |
film-coated tablets, 400 mg, 60 tablets in a glass bottle; 1 bottle in a carton; 15 tablets in a blister; 4 blisters in a carton |
CJSC Pharmaceutical Plant EGIS |
Hungary |
CJSC Pharmaceutical Plant EGIS |
Hungary |
amendments to registration materials:
Type I change – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 2004-069-Rev 01 from an already approved manufacturer for the API piracetam |
by prescription |
UA/8165/01/01 |
|
LUCETAM® |
film-coated tablets, 800 mg, 30 tablets in glass bottles; 15 tablets in a blister; 2 blisters in a cardboard box |
CJSC Pharmaceutical Plant EGIS |
Hungary |
CJSC Pharmaceutical Plant EGIS |
Hungary |
amendments to registration materials:
Type I change – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 2004-069-Rev 01 from an already approved manufacturer for the API piracetam |
by prescription |
UA/8165/01/02 |
|
LUCETAM® |
film-coated tablets, 1200 mg, 20 tablets in glass bottles; 10 tablets in a blister; 2 blisters in a cardboard box |
CJSC Pharmaceutical Plant EGIS |
Hungary |
CJSC Pharmaceutical Plant EGIS |
Hungary |
amendments to registration materials:
Type I change – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 2004-069-Rev 01 from an already approved manufacturer for the API piracetam |
by prescription |
UA/8165/01/03 |
|
MAGNE-B6 ® ANTISTRESS |
film-coated tablets, No. 60 (15х4): 15 tablets in a blister; 4 blisters in a cardboard box |
LLC “Sanofi-Aventis Ukraine” |
Ukraine |
Sanofi Winthrop Industrie, France; CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd. Plant 2 (Veresegyház plant), Hungary |
France/ Hungary |
amendments to registration materials: Type I variations – submission of an updated European Pharmacopoeia Certificate of Suitability R1-CEP 2009-017-Rev 00 from an already approved manufacturer for the API magnesium citrate anhydrous |
without
prescription |
UA/4130/01/01 |
|
MAXIGRA |
film-coated tablets, 50 mg; 1 or 4 tablets per blister; 1 blister per carton box |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
amendments to registration materials:
Type I changes – change in the batch size (including batch size ranges) of the finished medicinal product – change in the batch size of the finished medicinal product as a result of dividing the granulate during the manufacturing process of the medicinal product – proposed wording: dosage 50 mg – 19,20 kg/19,9 kg – 112941 tablets; 59,20 kg/61,64 kg – 348 325 tablets; dosage 100 mg – 35,00 kg/36,03 kg – 102 941 tablets; 59,20 kg/60,94 kg – 174 117 tablets; Type I changes – submission of a new certificate of suitability to the European Pharmacopoeia CEP 2013-072-Rev 01 (process A) from the already approved manufacturer of the API sildenafil citrate; Type I changes – changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product – the change is declared as a result of introducing minor changes in manufacture – introduction of the possibility of dividing the granulate to optimize the manufacturing process; Type I changes – submission of an updated certificate of suitability to the European Pharmacopoeia CEP 2013-072-Rev 03 (process A) from the already approved manufacturer of the API sildenafil citrate; Type I changes – submission of a new certificate of suitability to the European Pharmacopoeia CEP 2013-073-Rev 01 (process B) from the new manufacturer of the API sildenafil citrate; Type I changes – change in the specification parameters and/or limits of the finished medicinal product – change of the information given in the note to the specification of the medicinal product for the parameters: “Description”, “Average tablet weight”, “Related impurities”, “Assay”, “Dissolution”, with additional information on the control of the above parameters during stability studies; change in the specification of the medicinal product, addition of an alternative method for the parameter “Assay” (HPLC method) to the shelf-life specification (the HPLC method is available in the “release” specification); change in the specification of the medicinal product for the parameter “Average tablet weight” – replacement of the pharmacopoeial test method with the company's in-house method (S/6-0502) |
by prescription |
UA/14262/01/01 |
|
MAXIGRA |
film-coated tablets, 100 mg; 1 or 4 tablets per blister; 1 blister per carton box |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
amendments to registration materials:
Type I changes – change in the batch size (including batch size ranges) of the finished medicinal product – change in the batch size of the finished medicinal product as a result of dividing the granulate during the manufacturing process of the medicinal product – proposed wording: dosage 50 mg – 19,20 kg/19,9 kg – 112941 tablets; 59,20 kg/61,64 kg – 348 325 tablets; dosage 100 mg – 35,00 kg/36,03 kg – 102 941 tablets; 59,20 kg/60,94 kg – 174 117 tablets; Type I changes – submission of a new certificate of suitability to the European Pharmacopoeia CEP 2013-072-Rev 01 (process A) from the already approved manufacturer of the API sildenafil citrate; Type I changes – changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product – the change is declared as a result of introducing minor changes in manufacture – introduction of the possibility of dividing the granulate to optimize the manufacturing process; Type I changes – submission of an updated certificate of suitability to the European Pharmacopoeia CEP 2013-072-Rev 03 (process A) from the already approved manufacturer of the API sildenafil citrate; Type I changes – submission of a new certificate of suitability to the European Pharmacopoeia CEP 2013-073-Rev 01 (process B) from the new manufacturer of the API sildenafil citrate; Type I changes – change in the specification parameters and/or limits of the finished medicinal product – change of the information given in the note to the specification of the medicinal product for the parameters: “Description”, “Average tablet weight”, “Related impurities”, “Assay”, “Dissolution”, with additional information on the control of the above parameters during stability studies; change in the specification of the medicinal product, addition of an alternative method for the parameter “Assay” (HPLC method) to the shelf-life specification (the HPLC method is available in the “release” specification); change in the specification of the medicinal product for the parameter “Average tablet weight” – replacement of the pharmacopoeial test method with the company's in-house method (S/6-0502) |
by prescription |
UA/14262/01/02 |
|
MANINIL® 3,5 |
tablets of 3,5 mg, 120 tablets per bottle; 1 bottle per cardboard box |
BERLIN-CHEMIE AG |
Germany |
BERLIN-CHEMIE AG, Germany (Bulk production, batch control); BERLIN-CHEMIE AG, Germany (Batch control and release); Menarini-Von Heyden GmbH, Germany (Bulk production, primary and secondary packaging, batch control) |
Germany |
amendments to registration materials: Type I variations – changes concerning safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) – change of the contact details of the qualified person responsible for pharmacovigilance |
by
prescription |
UA/9669/01/01 |
|
MANINIL® 5 |
tablets 5 mg, 120 tablets per vial; 1 vial per box |
BERLIN-CHEMIE AG |
Germany |
BERLIN-CHEMIE AG, Germany (manufacturer responsible for bulk production); BERLIN-CHEMIE AG, Germany (manufacturer responsible for final packaging, batch release); Menarini-Von Heyden GmbH, Germany (manufacturer responsible for bulk production, final packaging) |
Germany |
amendments to registration materials:
Type I variations – changes made to the packaging labeling text of the medicinal product regarding the indication of international designations of units of measurement. Replacement of the packaging labeling text in accordance with the requirements of MoH of Ukraine order No. 460 of 23.07.2015. Implementation of changes within 6 months after approval |
by prescription |
UA/9669/01/02 |
|
MEGLIMID® |
tablets, 2 mg, 10 tablets per blister; 1 or 3, or 6, or 9, or 12 blisters per carton box |
KRKA, d.d., Novo Mesto |
Slovenia |
KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging); KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging, batch control and release); Specifar S.A., Greece (manufacturer responsible for bulk production) |
Slovenia/ Greece |
amendments to registration materials: type I variations – removal of the 1 mg strength of the medicinal product Meglimid®, tablets, from the registration dossier materials
Implementation of changes within 6 months after approval |
by prescription |
UA/6240/01/02 |
|
MEGLIMID® |
tablets, 3 mg, 10 tablets per blister; 1 or 3, or 6, or 9, or 12 blisters per carton box |
KRKA, d.d., Novo Mesto |
Slovenia |
KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging); KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging, batch control and release); Specifar S.A., Greece (manufacturer responsible for bulk production) |
Slovenia/ Greece |
amendments to registration materials: type I variations – removal of the 1 mg strength of the medicinal product Meglimid®, tablets, from the registration dossier materials
Implementation of changes within 6 months after approval |
by prescription |
UA/6240/01/03 |
|
MEGLIMID® |
tablets, 4 mg, 10 tablets per blister; 1 or 3, or 6, or 9, or 12 blisters per carton box |
KRKA, d.d., Novo Mesto |
Slovenia |
KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging); KRKA, d.d., Novo Mesto, Slovenia (manufacturer responsible for primary and secondary packaging, batch control and release); Specifar S.A., Greece (manufacturer responsible for bulk production) |
Slovenia/ Greece |
amendments to registration materials: type I variations – removal of the 1 mg strength of the medicinal product Meglimid®, tablets, from the registration dossier materials
Implementation of changes within 6 months after approval |
by prescription |
UA/6240/01/04 |
|
MEGLIMID® |
tablets of 2 mg, 10 tablets in a blister; 1 or 3, or 6, or 9, or 12 blisters in a cardboard box |
KRKA, d.d., Novo Mesto |
Slovenia |
manufacturer responsible for “in bulk” manufacturing:
Specifar S.A., Greece
manufacturer responsible for primary and secondary packaging, control and batch release:
KRKA, d.d., Novo mesto, Slovenia
Manufacturer responsible for primary and secondary packaging:
KRKA, d.d., Novo mesto, Slovenia |
Greece/ Slovenia |
amendments to registration materials: Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Content uniformity of divided tablets" for dosages of 2 mg, 3 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Uniformity of dosage units - uniformity of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Identification and assay of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - introduction of minor changes in the methods of determination for the parameter "Related substances" for dosages of 2 mg, 3 mg, 4 mg, namely: - increase of the chromatography run time from 30 min to approximately 190 min (25 times the retention time of the glimepiride peak), due to the delayed peaks of the placebo solution; - the disregard limit for peaks was reduced to 0,05%. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (secondary packaging site) - introduction of the finished medicinal product manufacturer responsible for secondary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg. Implementation of the changes within 6 months after approval; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (primary packaging site) - introduction of the finished medicinal product manufacturer responsible for primary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg (implementation of the changes within 6 months after approval); Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Changes in the manufacturing process of the finished medicinal product, including an intermediate product used in the manufacture of the finished medicinal product (minor change in the manufacturing process) - minor changes in the manufacturing process for dosages of 2 mg, 3 mg for the finished medicinal product manufacturer Specifar S.A., Greece. Implementation of the changes within 6 months after approval |
by
prescription |
UA/6240/01/02 |
|
MEGLIMID® |
tablets of 3 mg, 10 tablets in a blister; 1 or 3, or 6, or 9, or 12 blisters in a cardboard box |
KRKA, d.d., Novo Mesto |
Slovenia |
manufacturer responsible for “in bulk” manufacturing:
Specifar S.A., Greece
manufacturer responsible for primary and secondary packaging, control and batch release:
KRKA, d.d., Novo mesto, Slovenia
Manufacturer responsible for primary and secondary packaging:
KRKA, d.d., Novo mesto, Slovenia |
Greece/ Slovenia |
amendments to registration materials: Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Content uniformity of divided tablets" for dosages of 2 mg, 3 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Uniformity of dosage units - uniformity of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Identification and assay of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - introduction of minor changes in the methods of determination for the parameter "Related substances" for dosages of 2 mg, 3 mg, 4 mg, namely: - increase of the chromatography run time from 30 min to approximately 190 min (25 times the retention time of the glimepiride peak), due to the delayed peaks of the placebo solution; - the disregard limit for peaks was reduced to 0,05%. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (secondary packaging site) - introduction of the finished medicinal product manufacturer responsible for secondary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg. Implementation of the changes within 6 months after approval; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (primary packaging site) - introduction of the finished medicinal product manufacturer responsible for primary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg (implementation of the changes within 6 months after approval); Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Changes in the manufacturing process of the finished medicinal product, including an intermediate product used in the manufacture of the finished medicinal product (minor change in the manufacturing process) - minor changes in the manufacturing process for dosages of 2 mg, 3 mg for the finished medicinal product manufacturer Specifar S.A., Greece. Implementation of the changes within 6 months after approval |
by
prescription |
UA/6240/01/03 |
|
MEGLIMID® |
tablets, 4 mg, 10 tablets per blister; 1 or 3, or 6, or 9, or 12 blisters per carton box |
KRKA, d.d., Novo Mesto |
Slovenia |
manufacturer responsible for “in bulk” manufacturing:
Specifar S.A., Greece
manufacturer responsible for primary and secondary packaging, control and batch release:
KRKA, d.d., Novo mesto, Slovenia
Manufacturer responsible for primary and secondary packaging:
KRKA, d.d., Novo mesto, Slovenia |
Greece/ Slovenia |
amendments to registration materials: Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Uniformity of dosage units - uniformity of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - minor changes in the preparation of the standard solution and its storage conditions for the parameter "Identification and assay of glimepiride" for dosages of 2 mg, 3 mg, 4 mg. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (minor change to approved test methods) - introduction of minor changes in the methods of determination for the parameter "Related substances" for dosages of 2 mg, 3 mg, 4 mg, namely: - increase of the chromatography run time from 30 min to approximately 190 min (25 times the retention time of the glimepiride peak), due to the delayed peaks of the placebo solution; - the disregard limit for peaks was reduced to 0,05%. The acceptance criteria have not changed; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (secondary packaging site) - introduction of the finished medicinal product manufacturer responsible for secondary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg. Implementation of the changes within 6 months after approval; Type I variations - Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (primary packaging site) - introduction of the finished medicinal product manufacturer responsible for primary packaging, KRKA d.d., Slovenia, for dosages of 2 mg, 3 mg, 4 mg (implementation of the changes within 6 months after approval); |
by
prescription |
UA/6240/01/04 |
|
MEDITAN |
capsules, 100 mg, 10 capsules per blister; 3 blisters per cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendment of registration materials: Type I variation – changes to the test procedure for the parameter "Related substances", in particular: introduction of a sensitivity factor k into the formula for calculating the content of any non-specified impurity; Type I variation – amendments to the Specification/Test procedure of the finished medicinal product for the parameter "Microbiological purity", in particular: deletion of the full description of the procedure; addition of a reference to the current edition of the EP and SPhU; Type I variation – submission of an updated Certificate R1-CEP 2011-344-Rev 00 from the already approved manufacturer that changed its name |
by
prescription |
UA/12318/01/01 |
|
MEDITAN |
capsules of 300 mg, 10 capsules per blister; 3 or 6 blisters per cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendment of registration materials: Type I variation – changes to the test procedure for the parameter "Related substances", in particular: introduction of a sensitivity factor k into the formula for calculating the content of any non-specified impurity; Type I variation – amendments to the Specification/Test procedure of the finished medicinal product for the parameter "Microbiological purity", in particular: deletion of the full description of the procedure; addition of a reference to the current edition of the EP and SPhU; Type I variation – submission of an updated Certificate R1-CEP 2011-344-Rev 00 from the already approved manufacturer that changed its name |
by
prescription |
UA/12318/01/02 |
|
MEDITAN |
capsules, 400 mg, 10 capsules per blister; 3 blisters per cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendment of registration materials: Type I variation – changes to the test procedure for the parameter "Related substances", in particular: introduction of a sensitivity factor k into the formula for calculating the content of any non-specified impurity; Type I variation – amendments to the Specification/Test procedure of the finished medicinal product for the parameter "Microbiological purity", in particular: deletion of the full description of the procedure; addition of a reference to the current edition of the EP and SPhU; Type I variation – submission of an updated Certificate R1-CEP 2011-344-Rev 00 from the already approved manufacturer that changed its name |
by
prescription |
UA/12318/01/03 |
|
MEMANTINE HYDROCHLORIDE |
film-coated tablets, in
10 mg, in bulk: 10,3 kg; 7,7 kg; 5,7 kg; 4,25 kg; 3,1 kg of tablets in bags |
LLC “ASINO UKRAINE” |
Ukraine |
manufacture, packaging, analysis and batch release:
Synthon Hispania, S.L. |
Spain |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Container closure system. Change in the pack size of the finished medicinal product (other changes) – introduction of additional in-bulk packaging: 7,7 kg, 5,7 kg, 4,25 kg, 3,1 kg of tablets in bags, without a change in the packaging material, with corresponding changes in the section “Packaging” |
– |
UA/13170/01/01 |
|
MEMANTINE HYDROCHLORIDE |
film-coated tablets, in
20 mg, in bulk: 10,3 kg; 7,7 kg; 5,7 kg; 4,25 kg; 3,1 kg of tablets in bags |
LLC “ASINO UKRAINE” |
Ukraine |
manufacture, packaging, analysis and batch release:
Synthon Hispania, S.L. |
Spain |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Container closure system. Change in the pack size of the finished medicinal product (other changes) – introduction of additional in-bulk packaging: 7,7 kg, 5,7 kg, 4,25 kg, 3,1 kg of tablets in bags, without a change in the packaging material, with corresponding changes in the section “Packaging” |
– |
UA/13170/01/02 |
|
MENOVAZIN |
cutaneous solution; 40 ml in vials |
LLC “DKP “Pharmaceutical Factory”” |
Ukraine |
LLC “DKP “Pharmaceutical Factory”” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the active pharmaceutical ingredient (API), intermediate or finished medicinal product, packaging sites, manufacturer responsible for batch release, batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – deletion of a manufacturing site of the finished medicinal product (implementation of changes within 6 months after approval); Type I variations – Quality changes. Finished medicinal product. Control of the finished medicinal product. Change to specification parameters and/or acceptance limits of the finished medicinal product (other changes) – changes to the specification of the finished medicinal product related to the approval by the MoH of Ukraine of amendments to the formulation of the medicinal product “Menovazin” (MoH of Ukraine order No. 949 of 26.11.2012) in the test Identification D, Volume of the vial contents
Concomitant change
– Quality changes. Finished medicinal product. Control of the finished medicinal product. Change in the test methods of the finished medicinal product (other changes to test methods (including replacement or addition)) – changes in the quality control methods of the finished medicinal product related to the approval by the Ministry of Health of Ukraine of amendments to the formulation of the medicinal product “Menovazin” (MoH order No. 949 of 26.11.2012) for the items Identification D, Identification C, Volume of vial contents, Assay of benzocaine |
without
prescription |
UA/5829/01/01 |
|
METFORMIN |
film-coated tablets, 500 mg each, in bulk No. 1000 (1000 tablets per container); in bulk No. 1000 (10 tablets per blister; 100 blisters per pack) |
M.Biotech Limited |
Great Britain |
Indoco Remedies Limited |
India |
amendments to registration materials: Type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 1998-079-Rev 09 for the active substance Metformin Hydrochloride from an already approved manufacturer; Type I variations – introduction of an additional manufacturer for the active substance Metformin Hydrochloride, SOHAN HEALTHCARE PVT. LTD., India, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-233-Rev 00, in addition to the already approved manufacturer |
– |
UA/12646/01/01 |
|
METFORMIN |
film-coated tablets, 850 mg each, in bulk No. 1000 (1000 tablets per container); in bulk No. 1000 (10 tablets per blister; 100 blisters per pack) |
M.Biotech Limited |
Great Britain |
Indoco Remedies Limited |
India |
amendments to registration materials: Type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 1998-079-Rev 09 for the active substance Metformin Hydrochloride from an already approved manufacturer; Type I variations – introduction of an additional manufacturer for the active substance Metformin Hydrochloride, SOHAN HEALTHCARE PVT. LTD., India, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-233-Rev 00, in addition to the already approved manufacturer |
– |
UA/12646/01/02 |
|
METFORMIN |
film-coated tablets of 1000 mg in bulk No. 1000 (1000 tablets per container); in bulk No. 1000 (10 tablets per blister; 100 blisters per pack) |
M.Biotech Limited |
Great Britain |
Indoco Remedies Limited |
India |
amendments to registration materials: Type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 1998-079-Rev 09 for the active substance Metformin Hydrochloride from an already approved manufacturer; Type I variations – introduction of an additional manufacturer for the active substance Metformin Hydrochloride, SOHAN HEALTHCARE PVT. LTD., India, which holds a certificate of suitability to the European Pharmacopoeia No. R1-CEP 2009-233-Rev 00, in addition to the already approved manufacturer |
– |
UA/12646/01/03 |
|
METFORMIN SANDOZ® |
film-coated tablets, 500 mg, 10 tablets per blister, 3 or 12 blisters per carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek S.A., Poland (full-cycle manufacture; packaging, batch release) |
Poland |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/9477/01/01 |
|
METFORMIN SANDOZ® |
film-coated tablets, 850 mg, 10 tablets in a blister, 3 or 12 blisters in a cardboard box, 12 tablets in a blister, 10 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek S.A., Poland (full-cycle manufacture; packaging, batch release) |
Poland |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/9477/01/02 |
|
MIXTARD® 30 NM |
suspension for injection, 100 IU/ml, 10 ml per vial; 1 vial per cardboard box |
A/S Novo Nordisk |
Denmark |
A/S Novo Nordisk, Denmark (manufacturer for labeling and packaging of vials, secondary packaging); A/S Novo Nordisk, Denmark (manufacturer of bulk product, filling into vials, primary packaging, quality control, and responsible for batch release of the finished product); Novo Nordisk Production SAS, France (full-cycle manufacturer) |
Denmark/ France |
making changes to registration materials: Type I variations – administrative changes. Change of ATC code – amend the pharmacotherapeutic group and ATC code according to the WHO classifier of pharmacotherapeutic groups and ATC codes: approved – Antidiabetic drugs. Combinations of insulins of short and intermediate duration of action. ATC code A10A D01.; proposed – Antidiabetic drugs. Insulins and analogues for injection of intermediate and long duration of action in combination with short-acting insulins, human insulin. ATC code A10A D01. Implementation of changes within 6 months after approval |
by
prescription |
UA/2682/01/01 |
|
MIXTARD®30 NM PENFILL® |
suspension for injection, 100 IU/mL, 3 mL in a cartridge; 5 cartridges in a cardboard box |
A/S Novo Nordisk |
Denmark |
A/S Novo Nordisk, Denmark (manufacturer for labeling and packaging of Penfill®, secondary packaging); A/S Novo Nordisk, Denmark (manufacturer of the bulk product, filling into Penfill®, primary packaging, quality control and responsible for batch release of the finished product); Novo Nordisk Produção Farmacêutica do Brasil Ltda., Brazil (manufacturer of the bulk product, primary and secondary packaging); Novo Nordisk Production SAS, France (full-cycle manufacturer of the product) |
Denmark/ France |
making changes to registration materials: Type I variations – administrative changes. Change of ATC code – amend the pharmacotherapeutic group and ATC code according to the WHO classifier of pharmacotherapeutic groups and ATC codes: approved – Antidiabetic drugs. Combinations of insulins of short and intermediate duration of action. ATC code A10A D01.; proposed – Antidiabetic drugs. Insulins and analogues for injection of intermediate and long duration of action in combination with short-acting insulins, human insulin. ATC code A10A D01. Implementation of changes within 6 months after approval |
by
prescription |
UA/12612/01/01 |
|
MILDROCARD-N |
solution for injection, 100 mg/mL, 5 mL per ampoule; 10 ampoules per cardboard pack |
LLC «PHARMASEL» |
Ukraine |
Batch control and release:
LLC «PHARMASEL»,
Ukraine
Secondary packaging, control:
HOLOPACK Verpackungstechnik GmbH, Germany
Manufacture of bulk product, primary and secondary packaging, control:
HOLOPACK Verpackungstechnik GmbH, Germany |
Ukraine/ Germany |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites. (activity for which the manufacturer/importer is responsible, not including batch release) – change of address of the manufacturer HOLOPACK Verpackungstechnik GmbH, Germany, without change of the manufacturing site (Implementation of changes within 3 months after approval) |
by
prescription |
UA/10376/01/01 |
|
MYOZYME |
powder for concentrate for solution for infusion, 50 mg each, 1 vial with powder in a cardboard pack |
Genzyme Europe B.V. |
Netherlands |
Genzyme Ireland Limited, Ireland (vial filling and manufacture of the finished product, labeling and packaging, quality control of the finished dosage form, batch release); Genzyme Limited, United Kingdom (labeling and packaging of the finished dosage form, batch release); Genzyme Flanders bvba, Belgium (manufacture of the active substance, preparation of the medicinal product solution for lyophilization) |
Ireland/United Kingdom/Belgium |
Amendments to registration materials: Type II variations – changes in the manufacturing process of the API (the change concerns an active substance of biological/immunological origin or the use of chemical APIs in the manufacture of a medicinal product of biological/immunological origin, which may have a significant impact on the quality, safety and efficacy of the medicinal product, and does not concern a protocol) – the corresponding changes are reflected in the sections of the RD 3.2.S.2,3.2.S.4.4, 3.2.S.7,3.2.A.1, editorial corrections 3.2.S.2.2. 3.2.S.2.3. |
by
prescription |
UA/11618/01/01 |
|
MIRAMISTIN®-DARNYTSIA |
ointment, 5 mg/g, 15 g or 30 g per tube; 1 tube per pack; 1000 g per jar |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials:
Type I variations – changes made to the labeling text of the primary packaging |
without prescription |
UA/1804/01/01 |
|
MITOXANTRONE “EBEWE” |
concentrate for solution for infusion, 2 mg/mL, 5 mL (10 mg) or 10 mL (20 mg) in a vial; 1 vial in a box |
EBEWE Pharma Ges.m.b.H. Nfg.KG |
Austria |
EBEWE Pharma Ges.m.b.H. Nfg. KG, Austria (full manufacturing cycle); Labor L+S AG, Germany (testing); MPL Mikrobiologisches Prüflabor GmbH, Austria (testing) |
Austria/ Germany |
amendments to registration materials:
Type I variations – change in the shape or size of the container or closure (primary packaging) (sterile medicinal products) – editorial changes to section 3.2.P.7. Container closure system, namely updating and correction of information, a new wording of the specification limits for the items “Visual assessment”, “Hydrolytic resistance of vials”, “Dimensions”, “Routine tests”; replacement of old technical drawings with new ones; indication of dimensions and stoppers according to DIN – ISO 8362, etc. |
by prescription |
UA/3145/01/01 |
|
MITOXANTRONE “EBEWE” |
concentrate for solution for infusion, 2 mg/mL, 5 mL (10 mg) or 10 mL (20 mg) in a vial; 1 vial in a box |
EBEWE Pharma Ges.m.b.H. Nfg.KG |
Austria |
EBEWE Pharma Ges.m.b.H. Nfg. KG, Austria (full manufacturing cycle); Labor L+S AG, Germany (testing); MPL Mikrobiologisches Prüflabor GmbH, Austria (testing) |
Austria/ Germany |
amendments to registration materials: Type I variations – safety/efficacy and pharmacovigilance changes. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of the contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the master file location |
by
prescription |
UA/3145/01/01 |
|
MIFOTAB |
tablets of 200 mg, 3 tablets per blister; 1 blister per cardboard box |
BEST QUALITY PHARMACEUTICALS PA, LLC |
USA |
Novast Laboratories Ltd |
China |
amendments to registration materials: type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the finished medicinal product manufacturer Novast Laboratories Ltd, China, without change of the manufacturing site |
by prescription |
UA/12103/01/01 |
|
M-KAST |
chewable tablets of 4 mg, 10 tablets per blister; 3 blisters per cardboard box |
Aurobindo Pharma Ltd |
India |
Aurobindo Pharma Limited – Unit VII |
India |
amendments to registration materials: Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – clarification of the name and address of the finished medicinal product manufacturer, without a change of the manufacturing site (Implementation of changes within 6 months after approval) |
by
prescription |
UA/14341/01/01 |
|
M-KAST |
chewable tablets of 5 mg, 10 tablets per blister; 3 blisters per cardboard box |
Aurobindo Pharma Ltd |
India |
Aurobindo Pharma Limited – Unit VII |
India |
amendments to registration materials: Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – clarification of the name and address of the finished medicinal product manufacturer, without a change of the manufacturing site (Implementation of changes within 6 months after approval) |
by
prescription |
UA/14341/01/02 |
|
MONOSAN® |
tablets of 20 mg, 10 tablets per blister; 3 blisters per cardboard box |
PRO.MED.CS Praha a.s. |
Czech Republic |
KOOFARMA s.r.o., Czech Republic (primary and secondary packaging); PRO.MED.CS Praha a.s., Czech Republic (full-cycle manufacture); HBM Pharma s.r.o., Slovak Republic (manufacture, primary and secondary packaging, quality control) |
Czech Republic/ Slovak Republic |
amendments to registration materials:
Type I variations – deletion of one of the approved manufacturers of the active substance isosorbide mononitrate |
by prescription |
UA/4257/01/01 |
|
MONOSAN® |
tablets of 40 mg, 10 tablets per blister; 3 blisters per cardboard box |
PRO.MED.CS Praha a.s. |
Czech Republic |
KOOFARMA s.r.o., Czech Republic (primary and secondary packaging); PRO.MED.CS Praha a.s., Czech Republic (full-cycle manufacture); HBM Pharma s.r.o., Slovak Republic (manufacture, primary and secondary packaging, quality control) |
Czech Republic/ Slovak Republic |
amendments to registration materials:
Type I variations – deletion of one of the approved manufacturers of the active substance isosorbide mononitrate |
by prescription |
UA/4257/01/02 |
|
MONTELUKAST |
chewable tablets, 5 mg each, in bulk: 34000 tablets per double polyethylene bag; in bulk: 25 500 tablets per double polyethylene bag; in bulk: 19 000 tablets per double polyethylene bag; in bulk: 14 500 tablets per double polyethylene bag; in bulk: 11 000 tablets per double polyethylene bag; in bulk: 8 500 tablets per double polyethylene bag; in bulk: 6 500 tablets per double polyethylene bag; in bulk: 5 000 tablets per double polyethylene bag |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
all stages of manufacture except batch release:
Sanico N.V., Belgium;
manufacturing, analysis and batch release:
Synthon Hispania S.L., Spain |
Belgium/
Spain |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (other changes) – Introduction of a permissible deviation of ± 15% from the approved pack size (implementation of changes within 3 months after approval); Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (change in the number of units (e.g., tablets, ampoules, etc.) in the pack:) – Change outside the range of approved pack sizes – introduction of additional pack types of the medicinal product Montelukast 4 mg, 5 mg in bulk, without changing the packaging material: with corresponding changes to the section “Packaging”. Introduction of additional pack types of the medicinal product Montelukast 4 mg, 5 mg in bulk, without changing the packaging material: with corresponding changes to the section “Packaging” (implementation of changes within 3 months after approval) |
– |
UA/16207/02/02 |
|
MONTELUKAST |
chewable tablets of 4 mg; in bulk: 42 000 tablets in a double polyethylene bag; in bulk: 31 500 tablets in a double polyethylene bag; in bulk: 23 500 tablets in a double polyethylene bag; in bulk: 17 500 tablets in a double polyethylene bag; in bulk: 13 000 tablets in a double polyethylene bag; in bulk: 10 000 tablets in a double polyethylene bag; in bulk: 7 500 tablets in a double polyethylene bag; in bulk: 6 000 tablets in a double polyethylene bag |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
all stages of manufacture except batch release:
Sanico N.V., Belgium;
manufacturing, analysis and batch release:
Synthon Hispania S.L., Spain |
Belgium/
Spain |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (other changes) – Introduction of a permissible deviation of ± 15% from the approved pack size (implementation of changes within 3 months after approval); Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (change in the number of units (e.g., tablets, ampoules, etc.) in the pack:) – Change outside the range of approved pack sizes – introduction of additional pack types of the medicinal product Montelukast 4 mg, 5 mg in bulk, without changing the packaging material: with corresponding changes to the section “Packaging”. Introduction of additional pack types of the medicinal product Montelukast 4 mg, 5 mg in bulk, without changing the packaging material: with corresponding changes to the section “Packaging” (implementation of changes within 3 months after approval) |
– |
UA/16207/02/01 |
|
MONTELUKAST |
film-coated tablets of 10 mg; in bulk: 50 000 tablets in a double polyethylene bag, in bulk: 37 000 tablets in a double polyethylene bag, in bulk: 27 500 tablets in a double polyethylene bag, in bulk: 20 500 tablets in a double polyethylene bag, in bulk: 15 500 tablets in a double polyethylene bag, in bulk: 11 500 tablets in a double polyethylene bag, in bulk: 8 500 tablets in a double polyethylene bag, in bulk: 6 500 tablets in a double polyethylene bag |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
all stages of manufacture except batch release:
Sanico N.V., Belgium;
manufacturing, analysis and batch release:
Synthon Hispania S.L., Spain |
Belgium/ Spain |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (change in the number of units (e.g., tablets, ampoules, etc.) in the pack:) – Change outside the range of approved pack sizes – introduction of additional pack types, without changing the packaging material, with corresponding changes to the section “Packaging” (implementation of changes within 3 months after approval); Type I changes – Quality changes. Finished medicinal product. Container/closure system. Change in the pack size of the finished medicinal product (other changes) – introduction of a permissible deviation of ±15% from the approved pack size. Approved: in bulk: 50 000 tablets in a double polyethylene bag. Proposed: in bulk: 50 000 tablets in a double polyethylene bag (permissible deviation ±15 % (42 500 – 57 500 tablets)). Implementation of changes within 3 months after approval |
– |
UA/16207/01/01 |
|
NADROPARIN-PHARMEX |
solution for injection, 9500 IU anti-Xa/mL, 0,3 mL (2850 IU anti-Xa), 0,4 mL (3800 IU anti-Xa), 0,6 mL (5700 IU anti-Xa) or 0,8 mL (7600 IU anti-Xa) in pre-filled syringes; 2 pre-filled syringes in a blister pack or blister; 5 blister packs or blisters in a cardboard box; 0,3 mL (2850 IU anti-Xa), 0,4 mL (3800 IU anti-Xa), 0,6 mL (5700 IU anti-Xa) or 0,8 mL (7600 IU anti-Xa) in pre-filled syringes; 5 pre-filled syringes in a blister pack or blister; 2 blister packs or blisters in a cardboard box; 0,3 mL (2850 IU anti-Xa), 0,4 mL (3800 IU anti-Xa), 0,6 mL (5700 IU anti-Xa) or 0,8 mL (7600 IU anti-Xa) in pre-filled syringes; 1 pre-filled syringe in a blister pack or blister; 1 blister pack or blister in a cardboard box |
LLC “PHARMEX GROUP” |
Ukraine |
LLC “PHARMEX GROUP” |
Ukraine |
amendments to registration materials:
Type I variation – changes made to the “Adverse reactions” section of the instructions for medical use of the medicinal product |
by prescription |
UA/15411/01/01 |
|
NAKLOFEN |
gel, 10 mg/g, 60 g or 120 g of gel per tube; 1 tube per cardboard box |
KRKA, d.d., Novo Mesto |
Slovenia |
KRKA, d.d., Novo Mesto |
Slovenia |
amendment of registration materials: Type I variation – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the sales package (supported by real-time data) – extension of the shelf life of the finished medicinal product based on positive results of long-term real-time stability studies: Approved: Shelf life. 2 years Proposed: Shelf life. 3 years Implementation of the changes within 6 months after approval |
without
prescription |
UA/3480/05/01 |
|
ADENOSINE TRIPHOSPHATE SODIUM |
solution for injection, 10 mg/mL, 1 mL in an ampoule; 10 ampoules in a cardboard box; 1 mL in an ampoule; 5 ampoules in a blister; 2 blisters in a cardboard box; 1 mL in an ampoule; 10 ampoules in a blister; 1 blister in a cardboard box |
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovia Narodu” |
Ukraine |
all stages of manufacturing, quality control, batch release:
Limited Liability Company “Kharkiv Pharmaceutical Enterprise “Zdorovya Narodu””, Ukraine
all stages of manufacture, quality control:
Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine |
Ukraine |
amendments to the registration materials: Type I changes – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) Change in the shelf life of the finished medicinal product. Approved: 1 year; proposed: 2 years. Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Change in the batch size (including batch size ranges) of the finished medicinal product (other changes) change in the batch size of the medicinal product for the manufacturing site Limited Liability Company "Kharkiv Pharmaceutical Enterprise "Zdorovia Narodu" due to production needs. Approved: 75 L or 68 180 ampoules; proposed: 15 L or 13 500 ampoules; 50 L or 45 045 ampoules. Type II changes – Quality changes. Finished medicinal product. Changes in manufacture. Changes in the manufacturing process of the finished medicinal product, including an intermediate used in the manufacture of the finished medicinal product (a substantial change in the manufacturing process that may have a significant impact on the quality, safety and efficacy of the medicinal product)
Changes in the manufacturing technology of the finished dosage form: replacement of thermal sterilization (100°C 30 minutes) with sterilizing filtration ( and preparation of the medicinal product under aseptic conditions in order to eliminate the excess of the API of 23% and reduce the amount of impurities formed under the influence of temperature |
by
prescription |
UA/8827/01/01 |
|
NAPHTHYZIN® |
nasal drops 0,05%, 10 ml in a polyethylene bottle, 1 bottle in a cardboard pack; 10 ml in a polyethylene bottle with a dispenser or in a polyethylene bottle with a dropper stopper; 1 bottle in a cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials:
type I variations – change in batch size (including batch size range) of the finished medicinal product – introduction of an additional batch size of the finished medicinal product; proposed: 700 L (68 600 vials); 1000 L (98 600 vials) |
without prescription |
UA/0704/01/01 |
|
NAPHTHYZIN® |
nasal drops 0,1 %, 10 ml in a polyethylene bottle, 1 bottle in a cardboard pack; 10 ml in a polyethylene bottle with a dispenser or in a polyethylene bottle with a dropper stopper; 1 bottle in a cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials:
type I variations – change in batch size (including batch size range) of the finished medicinal product – introduction of an additional batch size of the finished medicinal product; proposed: 700 L (68 600 vials); 1000 L (98 600 vials) |
without prescription |
UA/0704/01/02 |
|
NEIROSPIN-ZDOROV'YA |
film-coated tablets, 1 mg, 10 tablets per blister; 2 or 6 blisters per carton box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine (all stages of manufacture, quality control, batch release); Limited Liability Company “PHARMEX GROUP”, Ukraine (all stages of manufacture, quality control) |
Ukraine |
amendments to registration materials: type I variations – in addition to the approved supplier of primary packaging (aluminum foil), new suppliers JSC “Technologiya”, Ukraine and LLC “Altrade”, Ukraine are introduced. Specifications and quality control methods are identical. There are no qualitative or quantitative changes in the composition of the packaging material; proposed: JSC “Rusal Sayanal”, Russian Federation,
JSC “Tekhnolohiia”, Ukraine, LLC “Altreid”, Ukraine; type I variation – submission of an updated certificate of suitability to the European Pharmacopoeia for the API Risperidone from the approved manufacturer; proposed: CEP: R1-CEP 2002 -151- Rev 06 |
by
prescription |
UA/1178/01/02 |
|
NEIROSPIN-ZDOROV'YA |
film-coated tablets, 2 mg, 10 tablets per blister; 2 or 6 blisters in a carton box labeled in Ukrainian and Russian |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine (all stages of manufacture, quality control, batch release); Limited Liability Company “PHARMEX GROUP”, Ukraine (all stages of manufacture, quality control) |
Ukraine |
amendments to registration materials: type I variations – in addition to the approved supplier of primary packaging (aluminum foil), new suppliers JSC “Technologiya”, Ukraine and LLC “Altrade”, Ukraine are introduced. Specifications and quality control methods are identical. There are no qualitative or quantitative changes in the composition of the packaging material; proposed: JSC “Rusal Sayanal”, Russian Federation,
JSC “Tekhnolohiia”, Ukraine, LLC “Altreid”, Ukraine; type I variation – submission of an updated certificate of suitability to the European Pharmacopoeia for the API Risperidone from the approved manufacturer; proposed: CEP: R1-CEP 2002 -151- Rev 06 |
by
prescription |
UA/1178/01/03 |
|
NEIROSPIN-ZDOROV'YA |
film-coated tablets, 4 mg, 10 tablets per blister; 2 or 6 blisters per carton box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine (all stages of manufacture, quality control, batch release); Limited Liability Company “PHARMEX GROUP”, Ukraine (all stages of manufacture, quality control) |
Ukraine |
amendments to registration materials: type I variations – in addition to the approved supplier of primary packaging (aluminum foil), new suppliers JSC “Technologiya”, Ukraine and LLC “Altrade”, Ukraine are introduced. Specifications and quality control methods are identical. There are no qualitative or quantitative changes in the composition of the packaging material; proposed: JSC “Rusal Sayanal”, Russian Federation,
JSC “Tekhnolohiia”, Ukraine, LLC “Altreid”, Ukraine; type I variation – submission of an updated certificate of suitability to the European Pharmacopoeia for the API Risperidone from the approved manufacturer; proposed: CEP: R1-CEP 2002 -151- Rev 06 |
by
prescription |
UA/1178/01/04 |
|
NEURO-NORM |
capsules, 10 capsules in a blister pack; 2 or 6 blister packs in a pack |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials:
Type I variations – deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of starting material, reagent or excipient – deletion of one of the approved manufacturers of the API Cinnarizine, Hikal Limited, India |
by prescription |
UA/3685/01/01 |
|
NEXAVAR® |
film-coated tablets, 200 mg each; 28 tablets per blister, 4 blisters in a cardboard pack |
Bayer AG |
Germany |
Bayer AG, Germany, Bayer Healthcare Manufacturing S.R.L., Italy |
Germany/ Italy |
amendments to registration materials:
Type I variations – section 3.2.R.3.3 Description of the manufacturing process and process controls (TRD T.08.04) contains references to specifications for AM-R-BL and must be updated. The change consists in compliance with the Ph. Eur. monograph. References to obsolete internal test methods and test method numbers are removed. Instead, references to Ph. Eur. are given. The specifications stated in the TRD and the manufacturing process remain unchanged |
by prescription |
UA/7141/01/01 |
|
NEO AMOXICLAV |
granules for oral suspension 875 mg+125 mg; 1,8 g in a sachet; 10 or 14 sachets in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Sandoz GmbH-TechOps |
Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/15551/01/01 |
|
NEOGABIN 150 |
capsules, 150 mg; 10 capsules per blister; 3 or 6 blisters in a cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460) – change of the applicant of the finished medicinal product due to the transfer of ownership and the marketing decision of the current and new applicant companies (Implementation period for the changes – within 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release) – the change in the spelling of the address of the manufacturing site of the finished medicinal product of the company LLC “Pharma Start”, without a change in the actual place of activity, is made in connection with the Decision of the Kyiv City Council of 10 November 2016 No. 315/1319 on renaming boulevards, streets and squares and naming public gardens in the city of Kyiv (Implementation period for the changes – within 6 months after approval); Type I changes – Changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – Change in the contact details of the qualified person responsible for pharmacovigilance. Change in the location where the main pharmacovigilance activities are performed. Change in the location of the master file |
by prescription |
UA/13702/01/01 |
|
NEOGABIN 75 |
capsules, 75 mg; 10 capsules per blister; 3 or 6 blisters in a cardboard pack |
LLC “ASINO UKRAINE” |
Ukraine |
LLC “Pharma Start” |
Ukraine |
amendments to registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460) – change of the applicant of the finished medicinal product due to the transfer of ownership and the marketing decision of the current and new applicant companies (Implementation period for the changes – within 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release) – the change in the spelling of the address of the manufacturing site of the finished medicinal product of the company LLC “Pharma Start”, without a change in the actual place of activity, is made in connection with the Decision of the Kyiv City Council of 10 November 2016 No. 315/1319 on renaming boulevards, streets and squares and naming public gardens in the city of Kyiv (Implementation period for the changes – within 6 months after approval); Type I changes – Changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – Change in the contact details of the qualified person responsible for pharmacovigilance. Change in the location where the main pharmacovigilance activities are performed. Change in the location of the master file |
by prescription |
UA/13702/01/02 |
|
NEOFLAZID |
thick extract (substance) in stainless steel containers or plastic canisters for pharmaceutical use |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
amendment of registration materials: type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the applicant's address |
– |
UA/16520/01/01 |
|
NIMID® |
tablets of 100 mg, for the manufacturer KUSUM HEALTHCARE PVT LTD, India: 10 tablets per blister; 1 blister per carton; 10 tablets per blister; 1 blister per carton; 10 cartons per box; for the manufacturer LLC “KUSUM PHARM” Ukraine: 10 tablets per blister; 1 blister per carton; 10 tablets per blister; 10 blisters per box |
LLC “GLEDPHARM LTD” |
Ukraine |
KUSUM HEALTHCARE PVT LTD, India
or
LLC “KUSUM PHARM”, Ukraine |
India/
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) – extension of the shelf life of the finished medicinal product. Approved: 3 years Proposed: 4 years (Implementation of the changes within 6 months after approval) |
by prescription |
UA/7649/02/01 |
|
NIMID® |
granules, 100 mg/2 g, 2 g per sachet; 30 sachets per carton |
LLC “GLEDPHARM LTD” |
Ukraine |
Kusum Healthcare Pvt Ltd, India
or
LLC “KUSUM PHARM”, Ukraine |
India/
Ukraine |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) – extension of the shelf life of the finished medicinal product. Approved: 3 years Proposed: 4 years (Implementation of the changes within 6 months after approval) |
by prescription |
UA/4240/03/01 |
|
NIMID® |
granules, 100 mg/2 g, in bulk No. 350 (1x350): 2 g in a sachet; 350 sachets in a cardboard box |
LLC “GLEDPHARM LTD” |
Ukraine |
Kusum Healthcare Pvt Ltd |
India |
amendments to registration materials: Type I variations – Quality changes. Finished medicinal product. Stability. Change in the shelf life or storage conditions of the finished medicinal product (extension of the shelf life of the finished medicinal product) – For the commercial packaging (supported by real-time data) – extension of the shelf life of the finished medicinal product. Approved: 3 years Proposed: 4 years (Implementation of the changes within 6 months after approval) |
– |
UA/12051/01/01 |
|
NIMOTOP® |
film-coated tablets, 30 mg each; 10 tablets per blister; 10 blisters per cardboard box |
Bayer AG |
Germany |
Bayer AG |
Germany |
amendments to registration materials: Type I variations - changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for conducting pharmacovigilance in Ukraine, if different from the person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) - change of the person responsible for pharmacovigilance: Proposed wording: Justin Daniels. Change of the contact details of the person responsible for pharmacovigilance. Change of the location of the main pharmacovigilance activities. Change of the location of the master file |
by
prescription |
UA/3871/02/01 |
|
NOVAGRA NEO |
film-coated tablets, 50 mg in bulk: 1000 tablets in plastic jars |
Euro Lifecare Private Limited |
India |
FDC Limited |
India |
amendments to registration materials: Type I variations – Administrative changes. Change of the name of the medicinal product
change of the medicinal product name Approved: KONEGRA Proposed: NOVAGRA NEO
Implementation of changes within 3 months after approval. |
– |
UA/6702/01/01 |
|
NOVAGRA NEO |
film-coated tablets, 100 mg in bulk: 1000 tablets in plastic jars |
Euro Lifecare Private Limited |
India |
FDC Limited |
India |
amendments to registration materials: Type I variations – Administrative changes. Change of the name of the medicinal product
change of the medicinal product name Approved: KONEGRA Proposed: NOVAGRA NEO
Implementation of changes within 3 months after approval. |
– |
UA/6702/01/02 |
|
NOVAGRA NEO |
film-coated tablets, 100 mg, 1 or 4 tablets per blister; 1 blister per carton box |
Euro Lifecare Private Limited |
India |
FDC Limited |
India |
making changes to registration materials: Type I variations – Administrative changes. Change of the name of the medicinal product. Approved: KONEGRA Proposed: NOVAGRA NEO
Implementation of changes within 3 months after approval. |
by prescription |
UA/6701/01/02 |
|
NOVAGRA NEO |
film-coated tablets, 50 mg, 1 or 2, or 4 tablets in a blister; 1 blister in a cardboard box |
Euro Lifecare Private Limited |
India |
FDC Limited |
India |
making changes to registration materials: Type I variations – Administrative changes. Change of the name of the medicinal product. Approved: KONEGRA Proposed: NOVAGRA NEO
Implementation of changes within 3 months after approval. |
by prescription |
UA/6701/01/01 |
|
NEUROPENTIN® |
hard capsules, 300 mg each, 10 capsules per blister; 1, 3 or 10 blisters in a cardboard pack |
KUSUM HEALTHCARE PVT LTD |
India |
KUSUM HEALTHCARE PVT LTD, India
Alternative manufacturer responsible for secondary packaging, quality control, and batch release:
LLC “KUSUM PHARM”, Ukraine |
India/ Ukraine |
amendments to registration materials: type I variations – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (a site where any manufacturing stages are carried out, except batch release, quality control, primary and secondary packaging, for non-sterile medicinal products)
Concomitant change
– Quality variations. Finished medicinal product. Manufacturing changes. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for primary packaging) – quality variations. Finished medicinal product. Manufacturing changes. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for secondary packaging) – addition of a manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, PIN 454774, India; Type I variations – Quality variations. Finished medicinal product. Manufacturing changes. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a manufacturer responsible for import and/or batch release) – including batch control/testing – addition of a manufacturing site KUSUM HEALTHCARE PVT LTD, Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Dist. Dhar, Madhya Pradesh, PIN 454774, India |
by
prescription |
UA/14034/01/01 |
|
OXALIPLATIN ACTAVIS |
powder for solution for infusion, 50 mg; 1 vial with powder in a cardboard pack |
LLC “Teva Ukraine” |
Ukraine |
Actavis Italy S.p.A., Italy, Sindan Pharma SRL, Romania |
Italy/ Romania |
amendments to registration materials: type I variations – changes to the package leaflet in the section “Adverse reactions” in accordance with updated safety information on the active substance. Implementation of changes within 3 months after approval |
by
prescription |
UA/6832/01/01 |
|
OXALIPLATIN ACTAVIS |
powder for solution for infusion, 100 mg; 1 vial with powder in a cardboard pack |
LLC “Teva Ukraine” |
Ukraine |
Actavis Italy S.p.A., Italy, Sindan Pharma SRL, Romania |
Italy/ Romania |
amendments to registration materials: type I variations – changes to the package leaflet in the section “Adverse reactions” in accordance with updated safety information on the active substance. Implementation of changes within 3 months after approval |
by
prescription |
UA/6832/01/02 |
|
OXALIPLATIN-TEVA |
concentrate for solution for infusion, 5 mg/mL, 4 mL (20 mg) or 10 mL (50 mg), or 20 mL (100 mg), or 40 mL (200 mg) in a vial; 1 vial per carton |
Teva Pharmaceutical Industries Ltd. |
Israel |
Pharmachemie B.V. |
Netherlands |
amendments to registration materials: type I variations – changes to the package leaflet in the section “Adverse reactions” in accordance with updated safety information on the active substance. Implementation of changes within 3 months after approval |
by
prescription |
UA/8832/01/01 |
|
OXYLITEN |
film-coated tablets, 20 mg each, 10 tablets per blister, 1 blister in a cardboard pack |
Grand Medical Group AG |
Switzerland |
Anfarm Hellas S.A. |
Greece |
amendments to registration materials:
Type I variations – variations concerning safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant’s pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant’s qualified person responsible for pharmacovigilance: Proposed wording: Reyhan Yildiz. Change of contact details of the applicant’s qualified person responsible for pharmacovigilance. Change of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Olena Bondarenko. Change of contact details of the contact person of the applicant’s qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the address of the master file and its number |
by prescription |
UA/13219/02/01 |
|
HYDROXYPROGESTERONE CAPROATE |
oily solution for injection, 12,5%; 1 ml per ampoule; 5 ampoules per blister; 2 blisters per cardboard pack |
LLC “PF “BIOPHARMA” |
Ukraine |
LLC “PF “BIOPHARMA” |
Ukraine |
amendments to registration materials:
Type I variation – changes to the test methods of the finished medicinal product, section “Assay. Benzyl benzoate” – changes to the chromatography conditions |
by prescription |
UA/3616/01/01 |
|
OCTAGAM 10% |
solution for infusion 10 %, 20 ml, 50 ml, 100 ml or 200 ml of solution for infusion in a vial; 1 vial in a cardboard box |
Octapharma Pharmazeutika Produktionsges.m.b.H. |
Austria |
Manufacturer responsible for full-cycle manufacturing, excluding secondary packaging:
Octapharma AB, Sweden
manufacturer responsible for full-cycle manufacturing:
Octapharma Pharmazeutika Produktionsges.m.b.H., Austria
Manufacturer responsible for full-cycle manufacturing, excluding secondary packaging:
Octapharma, France
manufacturer responsible for secondary packaging:
Octapharma Dessau GmbH, Germany |
Sweden/Austria/France/Germany |
amendments to registration materials: Type I changes – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – Type I changes: Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) Deletion of the manufacturing operation “secondary packaging” for the manufacturing site “Octapharma, France” (Implementation period for the changes – within 6 months after approval); Type I changes – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – Type I changes: Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – deletion of the manufacturing operation “secondary packaging” for the manufacturing site Octapharma AB, Sweden (Implementation period for the changes – within 6 months after approval) |
by
prescription |
UA/15583/01/01 |
|
OMEPRAZOLE-TEVA |
gastro-resistant hard capsules, 40 mg; 10 capsules per blister; 3 blisters in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Teva Pharma S.L.U. |
Spain |
amendments to registration materials:
Type I variation – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 1998-145-Rev 07 from the already approved manufacturer Union Quimico Farmaceutica, S.A. for omeprazole API |
by prescription |
UA/15152/01/01 |
|
OMEPRAZOLE-TEVA |
gastro-resistant hard capsules, 20 mg; 10 capsules per blister; 3 blisters in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Teva Pharma S.L.U. |
Spain |
amendments to registration materials:
Type I variation – submission of an updated Certificate of Suitability to the European Pharmacopoeia R1-CEP 1998-145-Rev 07 from the already approved manufacturer Union Quimico Farmaceutica, S.A. for omeprazole API |
by prescription |
UA/15152/01/02 |
|
OMEPRAZOLE-TEVA |
gastro-resistant hard capsules, 40 mg; 10 capsules per blister; 3 blisters in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Teva Pharma S.L.U. |
Spain |
amendments to registration materials: Type I variation – submission of an updated Certificate of Suitability of the European Pharmacopoeia No. R1-CEP 2011-065-Rev 01 from the already approved manufacturer of the API Omeprazole produced by PLIVA Hrvatska d.o.o., Croatia. Updated version of the CEP due to the removal of the “Heavy metals” test |
by
prescription |
UA/15152/01/01 |
|
OMEPRAZOLE-TEVA |
gastro-resistant hard capsules, 20 mg; 10 capsules per blister; 3 blisters in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Teva Pharma S.L.U. |
Spain |
amendments to registration materials: Type I variation – submission of an updated Certificate of Suitability of the European Pharmacopoeia No. R1-CEP 2011-065-Rev 01 from the already approved manufacturer of the API Omeprazole produced by PLIVA Hrvatska d.o.o., Croatia. Updated version of the CEP due to the removal of the “Heavy metals” test |
by
prescription |
UA/15152/01/02 |
|
ONGLYZA |
film-coated tablets, 5 mg each; 10 tablets per blister; 3 blisters in a cardboard box |
AstraZeneca UK Limited |
Great Britain |
Manufacturer “in bulk”:
AstraZeneca Pharmaceuticals LP, USA
Manufacturer responsible for primary and secondary packaging, batch release:
AstraZeneca UK Limited, United Kingdom
Manufacturer responsible for quality control:
AstraZeneca AB, Sweden |
USA/United Kingdom/Sweden |
amendments to registration materials: Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate product or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – Deletion of the manufacturer Bristol-Myers Squibb S.r.l., Italy, responsible for primary and secondary packaging and batch release; the remaining manufacturer AstraZeneca UK Limited, United Kingdom, performs the same functions as the deleted one. Changes were made to the package leaflet regarding the name and location of the manufacturer, and consequently corresponding changes to the labeling text of the medicinal product packaging (deletion of a manufacturing site). Implementation of the changes within 6 months after approval |
by
prescription |
UA/10715/01/02 |
|
ONGLYZA |
film-coated tablets, 2,5 mg each; 10 tablets per blister; 3 blisters in a cardboard box |
AstraZeneca UK Limited |
Great Britain |
Manufacturer “in bulk”:
AstraZeneca Pharmaceuticals LP, USA
Manufacturer responsible for primary and secondary packaging, batch release:
AstraZeneca UK Limited, United Kingdom
Manufacturer responsible for quality control:
AstraZeneca AB, Sweden |
USA/United Kingdom/Sweden |
amendments to registration materials: Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate product or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – Deletion of the manufacturer Bristol-Myers Squibb S.r.l., Italy, responsible for primary and secondary packaging and batch release; the remaining manufacturer AstraZeneca UK Limited, United Kingdom, performs the same functions as the deleted one. Changes were made to the package leaflet regarding the name and location of the manufacturer, and consequently corresponding changes to the labeling text of the medicinal product packaging (deletion of a manufacturing site). Implementation of the changes within 6 months after approval |
by
prescription |
UA/10715/01/01 |
|
ORZOL® -IN |
vaginal tablets, 10 tablets in a blister, 1 blister together with 10 applicators and a cardboard insert in a cardboard package |
SCAN BIOTECH LTD |
India |
Vivimed Labs Ltd |
India |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturing site, the place of manufacture has not changed; approved |
by prescription |
UA/15615/01/01 |
|
ORNISOL® |
solution for infusion, 5 mg/ml, 100 ml per bottle; 1 bottle per pack |
PJSC “Halychpharm” |
Ukraine |
PJSC “Halychpharm” |
Ukraine |
amendments to registration materials:
Type I variation – change of supplier of packaging materials or components – amendments to the registration dossier materials, section 3.2.P.7. Container closure system: removal of information on manufacturers of the primary packaging (glass bottles (vials), rubber stoppers and aluminum caps) |
by prescription |
UA/12227/01/01 |
|
ORFADIN |
hard capsules of 2 mg; 60 capsules per vial; 1 vial per cardboard package |
Swedish Orphan Biovitrum International AB |
Sweden |
Full-cycle manufacturing:
Apotek Production & Laboratories AB, Sweden
Quality control:
Apotek Production & Laboratories AB, Sweden |
Sweden |
Type I variations – amendments to the Instructions for medical use of the medicinal product in the section “Special warnings and precautions for use” in accordance with updated safety information on the active substance of the medicinal product according to the registration dossier materials |
by
prescription |
UA/13603/01/01 |
|
ORFADIN |
hard capsules of 5 mg; 60 capsules per vial; 1 vial per cardboard package |
Swedish Orphan Biovitrum International AB |
Sweden |
Full-cycle manufacturing:
Apotek Production & Laboratories AB, Sweden
Quality control:
Apotek Production & Laboratories AB, Sweden |
Sweden |
Type I variations – amendments to the Instructions for medical use of the medicinal product in the section “Special warnings and precautions for use” in accordance with updated safety information on the active substance of the medicinal product according to the registration dossier materials |
by
prescription |
UA/13603/01/02 |
|
ORFADIN |
hard capsules of 10 mg; 60 capsules per vial; 1 vial per cardboard package |
Swedish Orphan Biovitrum International AB |
Sweden |
Full-cycle manufacturing:
Apotek Production & Laboratories AB, Sweden
Quality control:
Apotek Production & Laboratories AB, Sweden |
Sweden |
Type I variations – amendments to the Instructions for medical use of the medicinal product in the section “Special warnings and precautions for use” in accordance with updated safety information on the active substance of the medicinal product according to the registration dossier materials |
by
prescription |
UA/13603/01/03 |
|
OSPAMOX® |
film-coated tablets, 500 mg each, 12 tablets per blister; 1 blister in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Sandoz GmbH-TechOps |
Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/3975/01/01 |
|
OSPAMOX® |
film-coated tablets, 1000 mg each, 6 tablets per blister; 2 blisters in a cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Sandoz GmbH-TechOps |
Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/3975/01/02 |
|
OTRIVIN |
nasal drops 0,1%; 10 mL in a vial with a pipette cap; 1 vial in a cardboard pack |
GSK Consumer Healthcare S.A. |
Switzerland |
GSK Consumer Healthcare S.A. |
Switzerland |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder). Change of the name and address of the applicant. Implementation of changes within 6 months after approval. Type I variations – Administrative changes. Change of the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site (activity for which the manufacturer/importer is responsible, including batch release). Change of the name and address of the manufacturer, without a change of the manufacturing site. Changes were made to the package insert regarding the name and location of the manufacturer, and consequently the corresponding changes to the text of the medicinal product’s packaging labeling. Implementation of changes within 6 months after approval. Type I variations – Changes concerning safety/efficacy and pharmacovigilance. Replacement of the packaging labeling text in accordance with the requirements of MoH of Ukraine order No. 460 of 23.07.2015, as well as indication of international symbols of units of measurement. Implementation of changes within 6 months after approval. |
without prescription |
UA/5206/01/02 |
|
OTRIVIN |
metered nasal spray 0,1%; 10 ml in a polymer bottle with a spray pump; 1 bottle per cardboard box |
GSK Consumer Healthcare S.A. |
Switzerland |
GSK Consumer Healthcare S.A. |
Switzerland |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the site where quality control is performed (activity for which the manufacturer/importer is responsible, including batch release) – change of the name and address of the manufacturer, without a change of the manufacturing site (implementation of changes within 6 months after approval); Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the name and address of the applicant (implementation of changes within 6 months after approval) |
without prescription |
UA/5206/02/01 |
|
OTRIVIN WITH MENTHOL AND EUCALYPTUS |
metered nasal spray 0,1%; 10 ml in a polymer bottle with a spray pump; 1 bottle per cardboard box |
GSK Consumer Healthcare S.A. |
Switzerland |
GSK Consumer Healthcare S.A. |
Switzerland |
amendments to registration materials: Type I variations - Administrative changes. Change in the name and/or address of the applicant (registration certificate holder). Change in the name and address of the applicant. Implementation of changes within 6 months after approval. Type I variations - Administrative changes. Change in the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site (activity for which the manufacturer/importer is responsible, including batch release). Change in the name and address of the manufacturer, without a change of the manufacturing site. Changes have been made to the package leaflet regarding the name and location of the manufacturer, and, as a consequence, corresponding changes to the labeling text of the medicinal product packaging. Implementation of changes within 6 months after approval |
without prescription |
UA/5416/01/01 |
|
OFTAQUIX® |
eye drops, 5 mg/mL; 5 mL in a dropper vial, 1 vial in a cardboard box |
Santen JSC |
Finland |
Manufacturer responsible for in bulk manufacturing, primary and secondary packaging, quality control:
NextPharma AT, Finland;
Manufacturer responsible for in-bulk manufacture, primary packaging:
Santen Pharmaceutical (China) Co. Ltd, China;
Manufacturer responsible for batch release:
Santen JSC, Finland |
Finland/
China |
amendment of registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, not including batch release). Change in the name of the manufacturing site responsible for manufacture, primary and secondary packaging, and quality control, from Santen Oy, Finland to NextPharma Oy, Finland, as a result of the sale of the manufacturing site. The manufacturer responsible for batch release remains unchanged. |
by prescription |
UA/3755/01/01 |
|
OFTAQUIX® |
eye drops, 5 mg/mL, 5 mL in a dropper vial, 1 vial in a cardboard box |
Santen JSC |
Finland |
Santen AT, Finland (manufacturer responsible for bulk manufacturing, primary packaging, secondary packaging); Santen AT, Finland (manufacturer responsible for chemical and microbiological testing and batch release); Santen Pharmaceutical (China) Co., Ltd, China (manufacturer responsible for bulk manufacturing, primary packaging) |
Finland/ China |
amendments to registration materials:
Type I variation – change of the name of the levofloxacin API manufacturer, without a change of manufacturing site |
by prescription |
UA/3755/01/01 |
|
OFTIMOL® |
eye drops, 5 mg/mL, 5 mL or 10 mL in a vial; 1 vial in a cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: Type I changes – bringing the control procedure for the API timolol maleate from the manufacturer Centaur Pharmaceuticals Private Limited, India, for the parameter “Related substances” into line with the requirements of the Timolol Maleate EP monograph, namely the sample preparation of the reference solution (b) was changed; Type I changes – changes to the control procedure for the API timolol maleate from the manufacturer Centaur Pharmaceuticals Private Limited, India, for the following parameters: – “Enantiomeric purity”. To optimize quality control of the timolol maleate substance, the use of an alternative standard sample, the reference standard (RS) of timolol maleate, was additionally introduced. – “Residual organic solvents”: when preparing the reference solution, the weighed portion of tert-butyl alcohol was reduced from “3,0 g” to “0,750 g”; the procedure was supplemented with headspace sampler parameters according to the manufacturer's documentation (CEP). The limits and chromatographic conditions were left unchanged; Type I changes – changes to the control procedure for the API timolol maleate from the manufacturer Centaur Pharmaceuticals Private Limited, India, for the parameter “Microbiological purity”, namely the description of the procedure was removed, since the control procedure for this parameter is carried out in accordance with the requirements of EP, supplemented with a reference to SPhU* (*- current edition); the acceptance criteria were left unchanged; Type I changes – introduction of periodic incoming control of the timolol maleate substance from the manufacturer Centaur Pharmaceuticals Private Limited for the parameter “Microbiological purity” – the first batch (the first delivery of the current year) and every fifth subsequent batch |
by
prescription |
UA/4314/01/02 |
|
OSCILLOCOCCINUM® |
dosed granules, 1 g in a canister; 6 canisters per cardboard box |
BOIRON |
France |
BOIRON |
France |
amendments to registration materials: clarification of the registration procedure in MoH of Ukraine order No. 1820 of 16.08.2019 in the course of making the amendments, technical errors in the packaging labeling text of the medicinal product were corrected: SECONDARY PACKAGING. Approved: 16. INFORMATION APPLIED IN BRAILLE OSCILLOCOCCINUM® 17. OTHER INDICATION FOR USE Homeopathic medicinal product Symptomatic treatment and prevention of influenza and acute respiratory viral infections manifested by fever, chills, body aches and headache. Graphic image of the Logo, a tube with granules, No. 6 Influenza and cold illnesses Barcode of the medicinal product (present on the packaging) Manufacturer’s internal code Braille. Proposed: 16. INFORMATION APPLIED IN BRAILLE OSCILLOCOCCINUM 17. OTHER INDICATION FOR USE Homeopathic medicinal product Symptomatic treatment and prevention of influenza and acute respiratory viral infections manifested by fever, chills, body aches and headache. Graphic image of the Logo, a tube with granules, No. 6 Influenza and cold illnesses Barcode of the medicinal product (present on the packaging) Manufacturer’s internal code.
PRIMARY PACKAGING Approved: 6. OTHER For oral use Reg. Cert. No. UA/9265/01/01 FLU AND COLDS Proposed: 6. OTHER For oral use Reg. Cert. No. UA/9265/01/01 FLU AND COLDS |
without prescription |
UA/9265/01/01 |
|
OSCILLOCOCCINUM® |
dosed granules, 1 g in a canister; 6 canisters per cardboard box |
Boiron |
France |
BOIRON |
France |
amendments to registration materials:
technical errors corrected in the instructions for medical use and in the packaging labeling text of the medicinal product |
without prescription |
UA/9265/01/01 |
|
PANGASTRO® |
powder for solution for injection, 40 mg, 1, or 5, or 10 vials of powder in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d. d. |
Slovenia |
amendments to registration materials:
Type I variations – changes in the test methods of the finished medicinal product, test “Related substances, degradation products” – addition of information to the note on the stability conditions for storage of the standard solution and the test sample solution, based on validation data; Type I variations – changes in the test methods of the finished medicinal product, test “Assay” – addition of information to the note on the stability and storage conditions of the standard solution and the test sample solution, based on validation data; Type I variations – changes in the test methods of the API in order to bring them into line with the requirements of the Ph. Eur. monograph, namely deletion of the test “Heavy metals”, inclusion of references to sections 3.2.P.1 description and composition of the medicinal product, .2.P.3.2 batch formula to Ph. Eur.; Type II variations – update of the DMF materials from Dr. Reddy’s for the active substance from version AP v03-00 2014-02 to EDMF (version 0000) AP / v 03-01/2015-10 |
by prescription |
UA/14142/01/01 |
|
PANTEX |
lyophilized powder for solution for injection, 40 mg; 1 or 10 vials with powder per carton package |
LLC “ASHA Formulations” |
Ukraine |
Genfarma Laboratorio, S.L., Spain; STERIL-GEN LIFE SCIENCES (P) LTD, India |
Spain/ India |
amendments to registration materials: Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: Andrii Vasyliovych Ivanytskyi. Change of the contact details of the applicant's qualified person responsible for pharmacovigilance |
by
prescription |
UA/14158/01/01 |
|
PECTOLVAN® STOP |
oral drops; 25 ml per vial; 1 vial per cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials:
type I variations – change in the name and/or address of the manufacturer's site of activity (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in API manufacture – change of the address of the manufacturer of the API guaifenesin Gennex Laboratories Limited, India, without change of the manufacturing site |
without prescription |
UA/10685/01/01 |
|
PEN-HERPEVIR® |
cream, 10 mg/g; 2 g in a tube, 1 tube in a pack |
PJSC “Kyivmedpreparat” |
Ukraine |
PJSC “Kyivmedpreparat” |
Ukraine |
amendments to registration materials: Type I variations – change of the name of the manufacturer of the API penciclovir without change of the manufacturing site; proposed: Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd, China. Implementation of the changes within 6 months after approval |
without
prescription |
UA/17283/01/01 |
|
PENTAXIM® VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR COMPONENT), INACTIVATED POLIOMYELITIS AND VACCINE FOR THE PREVENTION OF INFECTIONS CAUSED BY HAEMOPHILUS TYPE B, CONJUGATED, ADSORBED |
powder for Haemophilus influenzae type b and suspension for injection (0,5 ml); 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a cardboard box or in a standard export packaging in a cardboard box |
Sanofi Pasteur |
France |
Sanofi Pasteur, France; SANOFI S.P.A., Italy; Sanofi-Aventis Private Co. Ltd., Hungary |
France/Italy/Hungary |
amendments to registration materials:
Type II variation – change in the test methods of the API or of the starting material/intermediate/reagent used in the API manufacturing process – introduction of a new batch of the in-house standard (anti-diphtheria serum, batch S3190) for the flocculation test for the active substance purified diphtheria toxoid. Editorial corrections to section 3.2.S.5 |
by prescription |
UA/13010/01/01 |
|
PENTAXIM® VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR COMPONENT), INACTIVATED POLIOMYELITIS AND VACCINE FOR THE PREVENTION OF INFECTIONS CAUSED BY HAEMOPHILUS TYPE B, CONJUGATED, ADSORBED |
Haemophilus influenzae type b powder and suspension for injection (0,5 ml); 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a cardboard box. 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in standard export packaging placed in a cardboard box with the package leaflet. Labeled in Ukrainian or with a sticker in Ukrainian |
Sanofi Pasteur |
France |
Sanofi Pasteur, France; SANOFI S.P.A., Italy; Sanofi-Aventis Private Co. Ltd., Hungary |
France/Italy/Hungary |
amendments to registration materials:
Type I variation – change in the test procedure of the API or starting material/intermediate/reagent used in the API manufacturing process – minor changes to the "Identification" test of cyanogen bromide used as a raw material in the manufacture of the active substance Haemophilus influenzae type b (PRP-T). Implementation date of the changes: from April 2020; Type II variation – change in the test procedure of the finished medicinal product – changes to the test for free polysaccharide content (depolymerized PRP content) for the conjugated Haemophilus polysaccharide vaccine. Implementation date of the changes: from June 2020. |
by prescription |
UA/13010/01/01 |
|
PENTAXIM® VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR COMPONENT), INACTIVATED POLIOMYELITIS AND VACCINE FOR THE PREVENTION OF INFECTIONS CAUSED BY HAEMOPHILUS TYPE B, CONJUGATED, ADSORBED |
Haemophilus influenzae type b powder and suspension for injection (0,5 ml); 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a cardboard box. 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a standard export pack placed in a cardboard box with the package leaflet |
Sanofi Pasteur |
France |
Sanofi Pasteur, France; SANOFI S.P.A., Italy; Sanofi-Aventis Private Co. Ltd., Hungary |
France/Italy/Hungary |
amendments to registration materials: Type I variations - change in the test methods of the active pharmaceutical ingredient (API) or of the starting material/intermediate/reagent used in the API manufacturing process - replacement of the batch of the bovine serum albumin (BSA) reference standard used for the Bovine Serum Albumin (BSA) content test at the stage of the concentrated trivalent poliomyelitis vaccine from MN161831 to PN206883; Type I variations - updating information in the CTD on the manufacture of the concentrated trivalent poliomyelitis vaccine in accordance with the industrial documentation, correction of errors and historical discrepancies. Making editorial corrections to sections 3.2.S.4.2, 3.2.S.5 of the registration dossier, with no changes in actual practice;
Type I variations – change in the test methods of the API or of the starting material/intermediate/reagent used in the manufacturing process of the API – minor change to the approved Residual formaldehyde content test method for the concentrated trivalent poliomyelitis vaccine |
by
prescription |
UA/13010/01/01 |
|
PENTAXIM® VACCINE FOR THE PREVENTION OF DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR COMPONENT), INACTIVATED POLIOMYELITIS AND VACCINE FOR THE PREVENTION OF INFECTIONS CAUSED BY HAEMOPHILUS TYPE B, CONJUGATED, ADSORBED |
Haemophilus influenzae type b powder and suspension for injection (0,5 ml); 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a cardboard box; 1 vial with powder and 1 pre-filled syringe (0,5 ml) with an attached needle (or 2 separate needles) containing the suspension for injection, in a standard export pack placed in a cardboard box with the package leaflet. |
Sanofi Pasteur |
France |
Sanofi Pasteur, France; SANOFI S.P.A., Italy; Sanofi-Aventis Private Co. Ltd., Hungary |
France/Italy/Hungary |
amendments to registration materials: Type I variations – introduction of batch FA534188 of the reference standard used for the Free polysaccharide content test for the conjugated Haemophilus type b polysaccharide at the main stage of manufacture (active substance) |
by
prescription |
UA/13010/01/01 |
|
PERSEN® CARDIO |
hard capsules, 200 mg/160 mg, 8 capsules per blister; 2 blisters in a cardboard box |
Alvogen Malta Operations (ROW) Ltd |
Malta |
Lek Pharmaceutical Company d.d. |
Slovenia |
amendments to registration materials:
Type I variation – deletion of a manufacturing site for the API (dry extract of hawthorn leaves and flowers) Naturex Spain SL, Spain |
without prescription |
UA/10415/01/01 |
|
PYRIDOXINE-DARNYTSIA (VITAMIN B6-DARNYTSIA) |
solution for injection, 50 mg/mL, 1 mL in an ampoule, 5 ampoules in a blister pack; 2 blister packs in a carton |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials: Type I changes – amendments to the API specification in connection with bringing it into line with the requirements of SPhU/EP, taking into account the results of validation of analytical procedures, with additional editorial changes for the following parameters: – “Solubility”, “Identification A, B, B”, “Clarity of solution”, “Color of solution”, “pH of solution”, “Melting point”, “Loss on drying”, “Sulfated ash” and “Assay” – editorial corrections were made and a reference to EP was added; – “Identification C” – the limits and control procedure were left unchanged, editorial corrections were made, a reference to EP was added, trade names of chromatographic plates were added; – “Related substances” – the limits and control procedure were left unchanged, editorial corrections were made, a reference to EP was added, shelf lives of solutions and the mobile phase were added; – “Heavy metals” – removed from the specification; – “Microbiological purity” – brought into line with the requirements of EP 2.6.12, 5.1.4. Implementation of changes within 6 months after approval; concomitant change: change in the parameters of the specifications and/or acceptance limits set in the specifications for the API, or for a starting material/intermediate/reagent used in the manufacturing process of the API (other changes); Type I changes – submission of a new CEP for the API Pyridoxine hydrochloride No. R0-CEP 2013-165-Rev 01 from an already approved manufacturer, as a consequence the parameter “Heavy metals” was removed from the API specification. Implementation of changes within 6 months after approval |
by
prescription |
UA/5420/01/01 |
|
PRADAXA® |
hard capsules, 75 mg each, 10 capsules per blister; 1 or 3 or 6 blisters per box |
Boehringer Ingelheim International GmbH |
Germany |
Boehringer Ingelheim Pharma GmbH & Co. KG |
Germany |
amendments to registration materials:
Type I variations – change in the name and/or address of the manufacturer (including, where necessary, the quality control site) or of the master file holder for the API, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – replacement of the legal address of the manufacturer of the API starting material (n-Hexyl Chloroformate (n-HCF) Framochem Kft with the actual address, without change of the manufacturing site; change of the name and address of the manufacturer of the API starting material (BIBR 1048 Diamine), without change of the manufacturing site |
by prescription |
UA/10626/01/01 |
|
PRADAXA® |
hard capsules, 110 mg each, 10 capsules per blister; 1 or 3 or 6 blisters per box |
Boehringer Ingelheim International GmbH |
Germany |
Boehringer Ingelheim Pharma GmbH & Co. KG |
Germany |
amendments to registration materials:
Type I variations – change in the name and/or address of the manufacturer (including, where necessary, the quality control site) or of the master file holder for the API, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – replacement of the legal address of the manufacturer of the API starting material (n-Hexyl Chloroformate (n-HCF) Framochem Kft with the actual address, without change of the manufacturing site; change of the name and address of the manufacturer of the API starting material (BIBR 1048 Diamine), without change of the manufacturing site |
by prescription |
UA/10626/01/02 |
|
PRADAXA® |
hard capsules, 150 mg each, 10 capsules per blister; 3 or 6 blisters per cardboard box |
Boehringer Ingelheim International GmbH |
Germany |
Boehringer Ingelheim Pharma GmbH & Co. KG |
Germany |
amendments to registration materials:
Type I variations – change in the name and/or address of the manufacturer (including, where necessary, the quality control site) or of the master file holder for the API, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – change of the name and address of the manufacturer of the API starting material (BIBR 1048 Diamin), without change of the manufacturing site; replacement of the legal address of the manufacturer of the API starting material (n-Hexyl Chloroformate (n-HCF) Framochem Kft with the actual address, without change of the manufacturing site |
by prescription |
UA/10626/01/03 |
|
PRESARTAN®-50 |
film-coated tablets, 50 mg each; 10 tablets per blister; 3 blisters in a carton or 14 tablets per blister; 2 blisters in a carton |
Ipca Laboratories Limited |
India |
Ipca Laboratories Limited |
India |
amendments to registration materials:
Type I variation – update of the labeling text of the primary and secondary packaging |
by prescription |
UA/8575/01/02 |
|
PRILAMID |
tablets, 2 mg/0,625 mg, 10 tablets per blister, 2, or 3, or 6 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (“in bulk” manufacturing, packaging, control and batch release); Lek Pharmaceutical Company d.d., Slovenia (packaging) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/14225/01/01 |
|
PRILAMID |
tablets, 4 mg/1,25 mg, 10 tablets per blister, 2, or 3, or 6 blisters per cardboard box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d., Slovenia (“in bulk” manufacturing, packaging, control and batch release); Lek Pharmaceutical Company d.d., Slovenia (packaging) |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance: Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine: Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/14225/01/02 |
|
PROGESTERONE |
oily solution for injection 2,5%, 1 ml per ampoule; 5 ampoules per blister; 2 blisters per cardboard pack |
LLC “PF “BIOPHARMA” |
Ukraine |
LLC “PF” BIOPHARMA” |
Ukraine |
amendments to registration materials: Type I changes – changes in test methods for the Assay test. Benzyl benzoate. – changes in chromatography conditions |
by
prescription |
UA/3556/01/02 |
|
PROGESTERONE |
oily solution for injection 1%, 1 ml per ampoule; 5 ampoules per blister, 2 blisters per cardboard pack |
LLC “PF “BIOPHARMA” |
Ukraine |
LLC “PF” BIOPHARMA” |
Ukraine |
amendments to registration materials: Type I changes – changes in test methods for the Assay test. Benzyl benzoate. – changes in chromatography conditions |
by
prescription |
UA/3556/01/01 |
|
PROGESTERONE |
oily solution for injection 1%, 1 ml per ampoule; 5 ampoules per blister, 2 blisters per cardboard pack |
LLC “PF “BIOPHARMA” |
Ukraine |
LLC “PF” BIOPHARMA” |
Ukraine |
amendments to registration materials: type I variations – the phrase "determination is performed visually" was added to the section "Description"; in the section "Assay. Progesterone", changes to the limits established in the in-process specification of the finished medicinal product due to a change of the test method from spectrophotometry (SPhU, 2.2.25) to the HPLC method (SPhU, 2.2.29), since this method is used for control of the finished medicinal product; proposed: for 1% solution from 9.70 to 10.30 mg in 1 ml of intermediate product;
type I variations – addition of a new test method "Assay. Benzyl benzoate" – gas chromatography method (SPhU, 2.2.28) with the introduction of limits in the intermediate product specification from 18.6 % to 21.4 % |
by
prescription |
UA/3556/01/01 |
|
PROGESTERONE |
oily solution for injection 2,5%, 1 ml per ampoule; 5 ampoules per blister; 2 blisters per cardboard pack |
LLC “PF “BIOPHARMA” |
Ukraine |
LLC “PF” BIOPHARMA” |
Ukraine |
amendments to registration materials: Type I variations – the phrase “determination is performed visually” added to the section “Description”; to the section “Assay. Progesterone”, changes to the limits established in the specification during manufacture of the finished medicinal product due to a change of the test method from spectrophotometry (SPhU, 2.2.25) to HPLC (SPhU, 2.2.29), since this method is used for control of the finished medicinal product; proposed: for 2,5 % solution from 24.15 to 25.85 mg in 1 ml of intermediate product; Type I variations – addition of a new test method for the item “Assay. Benzyl benzoate” – gas chromatography method (SPhU, 2.2.28) with introduction of limits in the specification of the intermediate product from 18.6 % to 21.4 % |
by
prescription |
UA/3556/01/02 |
|
PROPROTEN-100 |
tablets, 20 tablets per blister; 1 or 2 blisters per cardboard box |
LLC “Materia Medica-Ukraine” |
Ukraine |
CJSC Santonika |
Lithuania |
amendments to registration materials: Type I variations - Administrative changes. Change in the name and/or address of the applicant (registration certificate holder) - change of address (implementation of changes within 3 months after approval); Type I variations - Changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for conducting pharmacovigilance in Ukraine, if different from the person responsible for pharmacovigilance (including contact details), and/or changes in the location of the pharmacovigilance system master file) - change of the contact details of the applicant's person responsible for pharmacovigilance |
without
prescription |
UA/3646/01/01 |
|
PROSTAZAN-VISTA |
hard modified-release capsules, 0,4 mg each, 10 capsules per blister, 3 blisters per cardboard box |
Mistral Capital Management Limited |
England |
Rottendorf Pharma GmbH, Germany (manufacturing, primary and secondary packaging, quality control); Synthon Hispania, S.L., Spain (manufacturing, primary and secondary packaging, quality control, batch release); Famar A.V.E. Anthousa Plant, Greece (manufacturing, primary and secondary packaging, quality control) |
Germany/Spain/Greece |
amendments to registration materials:
correction of a technical error in the quality control methods in the shelf-life specification under the “Dissolution” section |
By prescription |
UA/17058/01/01 |
|
PROTEFLAZID |
liquid extract (substance) in containers or canisters for pharmaceutical use |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
amendments to registration materials: Type I variations – Administrative variations. Change in the name and/or address of the applicant (registration certificate holder) – Change of the applicant’s address. |
– |
UA/16415/01/01 |
|
PROTOIL |
thick extract (substance) in stainless steel containers for pharmaceutical use |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
Limited Liability Company “Scientific and Production Company “Ekofarm” |
Ukraine |
amendment of registration materials: type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the applicant's address |
– |
UA/17258/01/01 |
|
RAMIPRIL |
crystalline powder (substance) in double polyethylene bags for pharmaceutical use |
LLC “KUSUM PHARM” |
Ukraine |
MELODY HEALTHCARE PVT. LTD. |
India |
making changes to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) change of the name and address of the applicant |
– |
UA/14490/01/01 |
|
REVMALGIN |
tablets 7,5 mg, 10 tablets per blister, 2 blisters per pack |
LLC “PHARMEX GROUP” |
Ukraine |
LLC “PHARMEX GROUP” |
Ukraine |
amendments to registration materials: correction of technical errors in quality control methods, changes to the quantitative composition of excipients in the “Composition” section |
by
prescription |
UA/11608/03/01 |
|
RENEIRO |
solution for injection, 250 mg/mL; 4 mL in an ampoule; 5 ampoules in a cassette; 1 cassette in a cardboard pack; 4 mL in an ampoule; 5 ampoules in a cassette; 2 cassettes in a cardboard pack |
LLC NPF “MIKROKHIM” |
Ukraine |
responsible for manufacture and control/testing of the batch, not including batch release:
Private Joint-Stock Company “Lekhim-Kharkiv”,
Ukraine;
responsible for manufacture and control/testing of the batch, including batch release:
LLC SPE “MIKROKHIM”, Ukraine |
Ukraine |
amendments to registration materials: Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, not including batch release) – change of the address of the finished medicinal product manufacturer, Private Joint-Stock Company “Lekhim-Kharkiv”, Ukraine, without a change of the manufacturing site (Implementation of the changes within 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the applicant (registration certificate holder) – change of the applicant's name (Implementation of the changes within 6 months after approval); Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release) – change of the name of the finished medicinal product manufacturer, without a change of the manufacturing site (Implementation of the changes within 6 months after approval); Type I changes – Changes related to safety/efficacy and pharmacovigilance. Changes to the summary of product characteristics, labeling text and package leaflet of generic/hybrid/biosimilar medicinal products following the same change to the reference product (the change does not require submission of any new additional data) – introduced into the “Adverse reactions” section of the leaflet in accordance with the information of the reference medicinal product GLIATILIN (solution for injection, 1000 mg/4 ml). Implementation of the changes within 6 months after approval |
by prescription |
UA/14966/01/01 |
|
RENNIE® ORANGE FLAVOR |
chewable tablets; 12 tablets in a perforated blister; 1 or 2 blisters in a cardboard box with labeling in Ukrainian and English; 6 tablets in a blister; 2 or 4 blisters in a cardboard box |
Bayer Consumer Care AG |
Switzerland |
Delpharm Gaillard |
France |
amendments to registration materials:
Type I variations – submission of an updated certificate of suitability to the European Pharmacopoeia CEP R1-CEP 2001-366-Rev 02 for the active substance calcium carbonate from the already approved manufacturer OMYA SAS, France, resulting in a change of the CEP holder's address |
without prescription |
UA/7799/01/01 |
|
RINAZOLIN® |
nasal drops, 0,5 mg/mL, 10 mL in a bottle with a dropper stopper or in a bottle with a dispenser, 1 bottle in a pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: Type I variations – change in the test methods of the finished medicinal product (other changes in test methods (including replacement or addition)); Type I variations – change in the test methods of the finished medicinal product (to bring them into compliance with the State Pharmacopoeia of Ukraine or the European Pharmacopoeia and to remove the reference to an obsolete in-house test method and its number); Type II variations – change in the specification parameters and/or acceptance limits of the finished medicinal product (the change is outside the approved specification limits) |
without
prescription |
UA/7191/01/01 |
|
RINAZOLIN® |
nasal drops, 0,25 mg/mL, 10 mL in a bottle with a dropper stopper or in a bottle with a dispenser, 1 bottle in a pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: Type I variations – change in the test methods of the finished medicinal product (other changes in test methods (including replacement or addition)); Type I variations – change in the test methods of the finished medicinal product (to bring them into compliance with the State Pharmacopoeia of Ukraine or the European Pharmacopoeia and to remove the reference to an obsolete in-house test method and its number); Type II variations – change in the specification parameters and/or acceptance limits of the finished medicinal product (the change is outside the approved specification limits) |
without
prescription |
UA/7191/01/02 |
|
RINAZOLIN® |
nasal drops, 0,1 mg/mL, 10 mL per bottle, 1 bottle per cardboard pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
making changes to the registration materials: Type I variations – change in the test methods of the finished medicinal product – changes to the test procedure “Related impurities” – the chromatographic conditions were changed, a reference solution was introduced for the determination and calculation of oxymetazoline impurity A. Due to the change of the “Related impurities” procedure, the “Assay” procedure was changed, since the procedures have similar chromatographic conditions (the only difference is the detection wavelengths); Type I variations – changes to the control methods of the finished medicinal product for the parameter “Microbiological purity” – the description of the procedure was removed, since the control procedure for this parameter is carried out in accordance with the requirements of the Ph. Eur., a reference to the SPhU* was added (*- current edition); the acceptance criteria were left unchanged; Type II variations – change in the specification parameters and/or acceptable limits of the finished medicinal product – bringing the acceptance criteria for the limits of related impurities content in the specification of the finished medicinal product at release and at shelf life into line with the recommendations of ICH Q3B |
without
prescription |
UA/7191/01/03 |
|
ROFAST |
film-coated tablets, in
10 mg; 10 tablets per blister; 3 blisters per cardboard box |
Aurobindo Pharma Ltd |
India |
Aurobindo Pharma Limited – Unit VII |
India |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the site of quality control. (activity for which the manufacturer/importer is responsible, including batch release)
Change of the name and address of the finished medicinal product manufacturer without a change of the manufacturing site. Implementation of the changes within 6 months after approval. |
by
prescription |
UA/14580/01/01 |
|
ROFAST |
film-coated tablets, in
20 mg; 10 tablets per blister; 3 blisters per cardboard box |
Aurobindo Pharma Ltd |
India |
Aurobindo Pharma Limited – Unit VII |
India |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the site of quality control. (activity for which the manufacturer/importer is responsible, including batch release)
Change of the name and address of the finished medicinal product manufacturer without a change of the manufacturing site. Implementation of the changes within 6 months after approval. |
by
prescription |
UA/14580/01/02 |
|
SALOFALK |
gastro-resistant prolonged-release granules, 1,5 g each, 2,79 g of granules in a “Granu-Stix” sachet; 35 sachets per box |
Dr. Falk Pharma GmbH |
Germany |
Dr. Falk Pharma GmbH, Germany (responsible for batch release of the finished product and alternative secondary packaging); Losan Pharma GmbH, Germany (manufacture of the dosage form, primary and secondary packaging); Pharbil Pharma GmbH, Germany (manufacture of the dosage form, primary and secondary packaging) |
Germany |
amendments to registration materials:
Type I variations – withdrawal of the certificate of suitability to the European Pharmacopoeia No. R1-CEP 2004-308-Rev 04 for the API mesalazine manufactured by Bayer Schering Pharma AG, Germany; proposed: PharmaZell GmbH, Germany R1-CEP 2003-203-Rev 01 |
by prescription |
UA/3745/01/04 |
|
SALOFALK |
gastro-resistant, prolonged-release granules, 1000 mg, 1860 mg of granules in “Granu-Stix” sachets; 50 sachets per box |
Dr. Falk Pharma GmbH |
Germany |
Dr. Falk Pharma GmbH, Germany (responsible for batch release of the finished product and alternative secondary packaging); Losan Pharma GmbH, Germany (manufacturer of the dosage form, primary and secondary packaging); Pharbil Pharma GmbH, Germany (manufacturer of the dosage form, primary and secondary packaging) |
Germany |
amendments to registration materials:
type I variation – withdrawal of the certificate of suitability to the European Pharmacopoeia No. R1-CEP 2004-308-Rev 04 for the API mesalazine manufactured by Bayer Pharma AG GmbH, Germany; proposed: PharmaZell GmbH, Germany R1-CEP 2003-203-Rev 01 |
by prescription |
UA/3745/01/02 |
|
SALOFALK |
gastro-resistant prolonged-release granules, 3 g each, 5,58 g of granules in a “Granu-Stix” sachet; 50 sachets per box |
Dr. Falk Pharma GmbH |
Germany |
Dr. Falk Pharma GmbH, Germany (responsible for batch release of the finished product and alternative secondary packaging); Losan Pharma GmbH, Germany (manufacture of the dosage form, primary and secondary packaging); Pharbil Pharma GmbH, Germany (manufacture of the dosage form, primary and secondary packaging) |
Germany |
amendments to registration materials:
Type I variation – withdrawal of the European Pharmacopoeia certificate of suitability No. R1-CEP 2004-308-Rev 04 for the mesalazine API manufactured by Bayer Schering Pharma AG, Germany; Proposed: PharmaZell GmbH, Germany R1-CEP 2003-203-Rev 01 |
by prescription |
UA/3745/01/03 |
|
SALOFALK |
gastro-resistant, prolonged-release granules, 500 mg, 930 mg of granules in “Granu-Stix” sachets; 50 sachets per box |
Dr. Falk Pharma GmbH |
Germany |
Dr. Falk Pharma GmbH, Germany (responsible for batch release of the finished product and alternative secondary packaging); Losan Pharma GmbH, Germany (manufacturer of the dosage form, primary and secondary packaging); Pharbil Pharma GmbH, Germany (manufacturer of the dosage form, primary and secondary packaging) |
Germany |
amendments to registration materials:
Type I variation – deletion of the certificate of suitability to the European Pharmacopoeia No. R1-CEP 2004-308-Rev 04 for the API mesalazine manufactured by Bayer Pharma AG GmbH, Germany |
by prescription |
UA/3745/01/01 |
|
SALOFALK |
enteric-coated tablets, 250 mg; 10 tablets in a blister; 5 or 10 blisters in a cardboard box |
Dr. Falk Pharma GmbH |
Germany |
Responsible for batch release of the finished product and alternative secondary packaging:
Dr. Falk Pharma GmbH, Germany
Manufacturer responsible for manufacturing the dosage form, primary and secondary packaging, and quality control:
Losan Pharma GmbH, Germany
Manufacturer responsible for primary and secondary packaging and quality control:
Losan Pharma GmbH, Germany |
Germany |
amendments to registration materials: Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for primary packaging) – introduction of an additional site of the approved manufacturer of the finished medicinal product responsible for primary packaging, Lohmann Pharma GmbH (in Eschbach). Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a site where batch control/testing takes place) – introduction of an additional site of the approved manufacturer of the finished medicinal product responsible for quality control, Lohmann Pharma GmbH (in Eschbach), and also indication of the “quality control” function for the approved site of the finished medicinal product Lohmann Pharma GmbH, Otto-Hahn-Strasse 13, 15, 79395, Germany, to avoid ambiguity in the documentation. • Type I changes – Quality changes. Finished medicinal product. Changes in manufacture. Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished medicinal product (site for secondary packaging) – introduction of an additional site of the approved manufacturer of the finished medicinal product responsible for secondary packaging, Lohmann Pharma GmbH (in Eschbach). Type I changes – Quality changes. Certificate of suitability/CEP of the European Pharmacopoeia/monograph. Submission of a new or updated certificate of suitability or deletion of a certificate of suitability to the European Pharmacopoeia: for an API; for a starting material/reagent/intermediate used in the manufacture of the API; for an excipient (certificate of suitability to the European Pharmacopoeia) – Deletion of certificates (where there is a multiple certificate for the material) – deletion of the certificate of suitability to the European Pharmacopoeia No. R1-CEP 2004-308 Rev 04 from the approved API manufacturer Bayer Pharma AG, Germany.
Type I variations – Administrative changes. Deletion of a manufacturing site (including sites for the active substance, intermediate product or finished medicinal product, packaging sites, manufacturer responsible for batch release, site where batch control takes place) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) – deletion of the manufacturer of the finished medicinal product responsible for manufacturing the dosage form, primary and secondary packaging, Rottendorf Pharma GmbH, Germany. |
by
prescription |
UA/3745/04/01 |
|
SMOFKABIVEN CENTRAL |
emulsion for infusion, 986 ml, 1477 ml, 1970 ml, 2463 ml in a three-chamber plastic container "Biofine", placed together with an oxygen absorber in an outer plastic bag; 986 ml, 1477 ml, 1970 ml in a three-chamber plastic container "Biofine", placed together with an oxygen absorber in an outer plastic bag; 4 bags per box; 2463 ml in a three-chamber plastic container "Biofine", placed together with an oxygen absorber in an outer plastic bag; 3 bags per box |
Fresenius Kabi Deutschland GmbH |
Germany |
Fresenius Kabi AB |
Sweden |
amendments to registration materials: Type I variations: deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient – deletion of the API manufacturer Sodium acetate Avantor Perfomance Material Inc., USA; deletion of the API manufacturer Sodium glycerophosphate Merck KGaA, Germany; deletion of the API manufacturer Isoleucine Ajinomoto North America, Inc., USA; deletion of the API manufacturer Isoleucine Ajinomoto Co. Inc., Kawasaki Plant, Japan; deletion of the API manufacturer Leucine Ajinomoto Co. Inc., Kawasaki Plant, Japan; deletion of the API manufacturer Leucine Ajinomoto North America, Inc., USA; deletion of the API manufacturer Lysine (as lysine acetate) Ajinomoto Co. Inc., Kawasaki Plant, Japan; deletion of the API manufacturer Serine Kyowa Hakko Bio Co., Ltd., Ube Plant, Japan; deletion of the API manufacturer Serine Evonik Rexim S.A.S. France; deletion of the API manufacturer Tyrosine Nippon rika Co., Ltd., Japan; deletion of the API manufacturer Phenylalanine Kyowa Hakko Bio Co., Ltd., Hofu Plant, Japan; Type I variations – new CEP No. R0-CEP 2015-375-Rev 00 from a new API manufacturer Zinc sulfate Macco Organiques, s.r.o., Czech Republic; new CEP No. R0-CEP 2013-157-Rev 00 from a new API manufacturer Alanine Amino GMBH, Germany; new CEP No. R0-CEP 2014-227-Rev 00 from an approved API manufacturer Lysine (as lysine acetate) Kyowa Hakko Bio Co., Ltd, Hofu Plant, Japan; new CEP No. R0-CEP 2014-063-Rev 00 from a new API manufacturer Lysine (as lysine acetate) Ajinomoto North America, Inc., USA; new CEP No. R0-CEP 2014-132-Rev 00 from a new API manufacturer Phenylalanine Shanghai Ajinomoto Amino Acid Co., Ltd., China; Type I variations – updated CEP from an approved API manufacturer Glucose Roquette Freres, France; proposed: R1-CEP 1996-030-Rev 04; updated CEP from an approved API manufacturer Calcium chloride Macco Organiques, s.r.o., Czech Republic; proposed: R1-CEP 2006-263-Rev 01; updated CEP from an approved API manufacturer Alanine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R0-CEP 2007-351-Rev 03; updated CEP from an approved API manufacturer Alanine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China.; proposed: R1-CEP 2004-086-Rev 04; updated CEP from an approved API manufacturer Arginine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2010-045-Rev 00; updated CEP from an approved API manufacturer Valine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2007-364-Rev 00; updated CEP from an approved API manufacturer Valine Shanghai Kyowa Amino Acid Co., Ltd., China. R1-CEP 2007-364-Rev 01; updated CEP from an approved API manufacturer Valine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China; proposed: R1-CEP 2008-128-Rev 01; updated CEP from an approved API manufacturer Histidine Shanghai Kyowa Amino Acid Co., Ltd., China.; proposed: R1-CEP 2010-046-Rev 00; updated CEP from an approved API manufacturer Histidine Shanghai Kyowa Amino Acid Co., Ltd., China. R1-CEP 2010-046-Rev 01; updated CEP from an approved API manufacturer Glycine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China; proposed: R1-CEP 2008-099-Rev 02; updated CEP from an approved API manufacturer Glycine Yuki Gosei Kogyo Co., Ltd., Japan; proposed: R1-CEP 1995-018-Rev 05; updated CEP from an approved API manufacturer Isoleucine Ajinomoto Do Brazil Industria e Comercio de Alimentos Ltda, Brazil.; proposed: R1-CEP 2009-100-Rev 00; updated CEP from an approved API manufacturer Isoleucine Amino GmbH, Germany; proposed: R1-CEP 2004-228-Rev 02; updated CEP from an approved API manufacturer Isoleucine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-188-Rev 00; updated CEP from an approved API manufacturer Leucine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-189-Rev 00; updated CEP from an approved API manufacturer Methionine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China; proposed: R1-CEP 2005-190-Rev 01; updated CEP from an approved API manufacturer Methionine Evonik Rexim Nanning Pharmaceutical Co., Ltd., China. R1-CEP 2005-190-Rev 02; updated CEP from an approved API manufacturer Methionine Sekisui Medical Co., Ltd., Japan.; proposed: R1-CEP 1999-136-Rev 04; updated CEP from an approved API manufacturer Methionine Sekisui Medical Co., Ltd., Japan. R1-CEP 1999-136-Rev 05; updated CEP from an approved API manufacturer Proline Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-263-Rev 00; updated CEP from an approved API manufacturer Serine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2008-003-Rev 00; updated CEP from an approved API manufacturer Serine Amino GmbH, Germany; proposed: R1-CEP 2006-315-Rev 02; updated CEP from an approved API manufacturer Threonine Shanghai Kyowa Amino Acid Co., Ltd., China; proposed: R1-CEP 2010-044-Rev 00; Type I variations – change in the name and/or address of the manufacturer (including, where applicable, the quality control site) or of the holder of the master file for the API, or of a supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – change of the name of the manufacturer of the active substance medium-chain triglycerides; Type I variations – submission of a new CEP No. R0-CEP 2012-410-Rev 01 for the API medium-chain triglycerides from an approved manufacturer; Type I variations – change in the retest period/shelf life or storage conditions of the API – specification of a retest period of 24 months for Alanine manufactured by Amino GmbH, Germany; Type I variations – change in the retest period/shelf life or storage conditions of the API – change of the retest period for Taurine manufactured by Kyowa Hakko Bio Co., Ltd, Hofu Plant, Japan from 12 to 36 months |
for use in a hospital setting only |
UA/14346/01/01 |
|
SPAZMALGON® |
solution for injection, 2 mL or 5 mL in an ampoule; 5 or 10 ampoules in a blister; 1 blister in a cardboard pack |
JSC “Sopharma” |
Bulgaria |
JSC “Sopharma” |
Bulgaria |
amendments to registration materials: Type I variations - deletion of a manufacturing site (including sites for the API, intermediate product or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the batch control site) or of a supplier of a starting material, reagent or excipient - deletion of the manufacturer of the API Pitofenone hydrochloride Zentiva, k.s., Czech Republic; Type I variations - change in specification parameters and/or limits set out in the specifications for the API, or for a starting material/intermediate/reagent used in the API manufacturing process - introduction into the specification of the API Pitofenone hydrochloride of the parameter "Bacterial endotoxins" (acceptance criteria: less than 0,07 IU/mg) in accordance with Ph. Eur. 2.6.14; introduction into the specification of the API Metamizole sodium of the parameter "Bacterial endotoxins" (acceptance criteria: less than 0,07 IU/mg) in accordance with Ph. Eur. 2.6.14.; Type I variations - changes related to the need to bring the specification into line with a monograph of the SPhU or the European Pharmacopoeia, or another national pharmacopoeia of an EU Member State - bringing the specification of the API Pitofenone hydrochloride for the parameter "Microbiological purity" into line with the EP; bringing the specification of the API Metamizole sodium monohydrate for the parameter "Microbiological purity" into line with the EP. The control method has not changed; Type I variations - updated certificate for the API Metamizole sodium monohydrate from the already approved manufacturer SHANDONG XINHUA PHARMACEUTICAL CO., LTD., China CEP No. 1 R1-CEP 2001-356-Rev 03; Type I variations - submission of a new certificate of suitability of the European Pharmacopoeia CEP No. R0-CEP 2014-091-Rev 00 from a new manufacturer of the API Metamizole sodium monohydrate WUHAN WUYAO PHARMACEUTICAL CO., LTD, China. As a consequence, introduction of the parameters "Ethanol" and "Formaldehyde" and a retest period of 3 years; Type I variations - updated certificate for the API Metamizole sodium monohydrate from the already approved manufacturer SHANDONG XINHUA PHARMACEUTICAL CO., LTD., China CEP No. 1 R1-CEP 2001-356-Rev 04; Type II variations - change of the manufacturer of a starting material/intermediate/reagent used in the API manufacturing process, or change of the manufacturer (including, where necessary, the quality control site) of the API - introduction of the manufacturer of the API Fenpiverinium bromide Sofarma A.D., Bulgaria |
by
prescription |
UA/3531/01/01 |
|
SPIRONOLACTONE SANDOZ® |
tablets, 50 mg, 10 tablets in a blister; 2, or 3, or 6 blisters in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/14227/01/01 |
|
SPIRONOLACTONE SANDOZ® |
tablets, 100 mg, 10 tablets in a blister; 2, or 3, or 6 blisters in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Salutas Pharma GmbH |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/14227/01/02 |
|
TAKNI |
hard capsules, 0,5 mg each, 10 capsules per blister; 5 blisters in a sealed pouch in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Laboratorios Cinfa S.A.
(Manufacture of bulk product, primary and secondary packaging;
Primary and secondary packaging, batch release authorization) |
Spain |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, not including batch release) Clarification of the address of the manufacturer Laboratorios Cinfa S.A., Spain, without change of the manufacturing site. Implementation of the changes within 6 months after approval. |
by prescription |
UA/14248/01/01 |
|
TAKNI |
hard capsules, 1 mg each, 10 capsules per blister; 5 blisters in a sealed pouch in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Laboratorios Cinfa S.A.
(Manufacture of bulk product, primary and secondary packaging;
Primary and secondary packaging, batch release authorization) |
Spain |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, not including batch release) Clarification of the address of the manufacturer Laboratorios Cinfa S.A., Spain, without change of the manufacturing site. Implementation of the changes within 6 months after approval. |
by prescription |
UA/14248/01/02 |
|
TAKNI |
hard capsules, 5 mg each, 10 capsules per blister; 5 blisters in a sealed pouch in a box |
Teva Pharmaceutical Industries Ltd. |
Israel |
Laboratorios Cinfa S.A.
(Manufacture of bulk product, primary and secondary packaging;
Primary and secondary packaging, batch release authorization) |
Spain |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, not including batch release) Clarification of the address of the manufacturer Laboratorios Cinfa S.A., Spain, without change of the manufacturing site. Implementation of the changes within 6 months after approval. |
by prescription |
UA/14248/01/03 |
|
TAMOXIFEN “EBEWE” |
tablets, 20 mg, 30 tablets per container; 1 container per box |
EBEWE Pharma Ges.m.b.H. Nfg.KG |
Austria |
Haupt Pharma Amareg GmbH, Germany (manufacture of bulk product, primary and secondary packaging, testing); EBEWE Pharma Ges.m.b.H. Nfg. KG, Austria (batch release, testing); Salutas Pharma GmbH, Germany (batch release, testing) |
Germany/ Austria |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/2894/01/02 |
|
TAFEN® NASAL |
nasal spray, suspension, 50 mcg/dose, 10 ml (200 doses) in a bottle; 1 bottle in a carton box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Lek Pharmaceutical Company d.d. |
Slovenia |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/7386/01/01 |
|
TWINRIX™ VACCINE FOR PREVENTION OF HEPATITIS A (INACTIVATED) AND B (ADSORBED) |
suspension for injection, 1 dose (1 ml/dose) in a prefilled syringe No. 1 with a needle |
GlaxoSmithKline Export Limited |
Great Britain |
GlaxoSmithKline Biologicals S.A. |
Belgium |
amendments to registration materials: Type I variations – change in the test methods of the API or starting material/intermediate/reagent used in the manufacturing process of the API – review and update of the documentation describing the manufacturing process of the intermediate product purified Hepatitis B antigen (HbsAg) and the description of the raw materials used during the process. Editorial corrections to dossier sections 3.2.S.2.2 and 3.2.S.2.3; Type I variations – changes in the API manufacturing process – alignment of the registered documents on the composition of the fermentation medium F1600 with the documents used in production; correction of inconsistencies in analytical references in the quality control of intermediate raw materials during the manufacture of the intermediate product purified Hepatitis B antigen |
by
prescription |
UA/13056/01/01 |
|
TETRACYCLINE HYDROCHLORIDE |
film-coated tablets of 100 mg in bulk: 1 kg of tablets in bags |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
amendments to registration materials: type I variations – deletion of the "Heavy metals" test from the API specification, in connection with bringing it into compliance with the requirements of the Ph. Eur. monograph "TETRACYCLINE HYDROCHLORIDE" (current edition); type I variations – changes to the finished medicinal product specification for the "Uniformity of dosage units" test, in connection with bringing it into compliance with the requirements of the SPhU/Ph. Eur.; type I variations – deletion of the "Talc" test from the finished medicinal product specification, bringing it into compliance with the requirements of the SPhU/Ph. Eur. |
– |
UA/10869/01/01 |
|
TETRACYCLINE HYDROCHLORIDE |
film-coated tablets, 100 mg each, 20 tablets per blister, 1 blister in a cardboard pack |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
Public Joint-Stock Company “Scientific and Production Center “Borshchahivskyi Chemical and Pharmaceutical Plant” |
Ukraine |
amendments to registration materials: type I variations – deletion of the "Heavy metals" test from the API specification, in connection with bringing it into compliance with the requirements of the Ph. Eur. monograph "TETRACYCLINE HYDROCHLORIDE" (current edition); type I variations – changes to the finished medicinal product specification for the "Uniformity of dosage units" test, in connection with bringing it into compliance with the requirements of the SPhU/Ph. Eur.; type I variations – deletion of the "Talc" test from the finished medicinal product specification, bringing it into compliance with the requirements of the SPhU/Ph. Eur. |
by
prescription |
UA/3520/01/01 |
|
TIZIN® XYLO |
nasal spray, solution 0,05%; 10 ml per vial; 1 vial per cardboard package |
McNeil Products Limited |
United Kingdom |
FAMAR ORLEANS |
France |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release). Change of the address of the manufacturer FAMAR ORLEANS, France, without change of the manufacturing site. Implementation period of the changes: within 6 months after approval. |
without prescription |
UA/8179/01/01 |
|
TIZIN® XYLO |
nasal spray, solution 0,1%; 10 ml per vial; 1 vial per cardboard package |
McNeil Products Limited |
United Kingdom |
FAMAR ORLEANS |
France |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control sites (activity for which the manufacturer/importer is responsible, including batch release). Change of the address of the manufacturer FAMAR ORLEANS, France, without change of the manufacturing site. Implementation period of the changes: within 6 months after approval. |
without prescription |
UA/8179/01/02 |
|
TIZIN® XYLO |
nasal drops, solution 0,05%; 10 ml per vial; 1 vial per cardboard package |
McNeil Products Limited |
United Kingdom |
FAMAR ORLEANS |
France |
amendments to registration materials: Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturer FAMAR ORLEANS, France, without a change of the manufacturing site (Implementation of changes within 6 months after approval) |
without prescription |
UA/4817/01/01 |
|
TIZIN® XYLO |
nasal drops, solution 0,1%; 10 ml per vial; 1 vial per cardboard package |
McNeil Products Limited |
United Kingdom |
FAMAR ORLEANS |
France |
amendments to registration materials: Type I changes – Administrative changes. Change in the name and/or address of the manufacturer/importer of the finished medicinal product, including batch release sites or the quality control site. (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturer FAMAR ORLEANS, France, without a change of the manufacturing site (Implementation of changes within 6 months after approval) |
without prescription |
UA/4817/01/02 |
|
TIVOMAX® A |
oral solution, 200 mg/mL, 100 mL or 200 mL per bottle; 1 bottle with a measuring spoon or measuring cup per pack |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
PrJSC “Pharmaceutical Firm “Darnytsia”” |
Ukraine |
amendments to registration materials: Type I variations – quality changes. Medical devices (other changes) introduction of an additional device – a measuring cup for measuring the dose of the medicinal product.
Implement the changes within 6 months after approval. |
without
prescription |
UA/16994/01/01 |
|
TONSILOTREN |
tablets, 20 tablets per blister; 3 blisters per cardboard box |
Alpen Pharma GmbH |
Germany |
In-bulk products:
Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Germany
or
Dr. Willmar Schwabe GmbH & Co. KG, Germany;
Manufacturer performing primary and secondary packaging:
Dr. Willmar Schwabe GmbH & Co. KG, Germany;
Manufacturer responsible for batch release:
Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Germany |
Germany |
amendments to the registration materials: change of applicant (registration certificate holder) (according to MoH order of 23.07.2015 No. 460). Approved: Deutsche Homoeopathie-Union DHU-Arzneimittel GmbH & Co. KG, Germany. Deutsche Homoeopathie-Union DHU-Arzneimittel GmbH & Co. KG, Germany. Proposed: Alpen Pharma GmbH, Germany
Alpen Pharma GmbH, Germany. Type I variations – Safety/efficacy and pharmacovigilance changes. Introduction of, or changes to, the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) (B.I.8. (a) IAnp)
Current wording: The applicant’s authorized person responsible for pharmacovigilance – Dr. Anja Hofner / Dr. Anya Hofner. The applicant’s contact person responsible for pharmacovigilance – Anton Voitenko. Proposed wording: The applicant’s authorized person responsible for pharmacovigilance – Anton Voitenko. Change of contact details of the authorized person responsible for pharmacovigilance. Change of the location where the main pharmacovigilance activities are performed. Change of the location of the master file. |
without prescription |
UA/3781/01/01 |
|
TONSIPRET® |
lozenges, 25 lozenges in a blister; 2 blisters or 4 blisters in a carton box |
Bionorica SE |
Germany |
Bionorica SE |
Germany |
amendments to registration materials:
Type I variations – change in the name and/or address of the manufacturer (including, where relevant, the quality control site), or of the master file holder for an API, or of the supplier of an API/starting material/reagent/intermediate used in the manufacture of an API – change of the address of the API manufacturer (control) for all mother tinctures (Phytolacca americana O, Capsicum D3 and Guaiacum D3), without changing the manufacturing site; change of the name of the contract laboratory where control is performed for all mother tinctures (Phytolacca americana O, Capsicum D3 and Guaiacum D3) and the finished medicinal product, without changing the manufacturing site; Type I variations – deletion of the manufacturing site Bionorica SE as a supplier of the plant raw material Capsicum anuum L. and manufacturer of the mother tincture Capsicum anuum D3. As part of the submitted procedure, the manufacturer's name was corrected; deletion of the manufacturing site Bionorica SE as a supplier of the plant substance Phytolacca americana L. and manufacturer of the mother tincture Phytolacca americana O. As part of the submitted procedure, the manufacturer's name was corrected; deletion of the manufacturing site Bionorica SE as a supplier of the starting substance Guaiacum drug and manufacturer of the mother tincture Guaiacum D3. As part of the submitted procedure, the manufacturer's name was corrected; deletion of the manufacturer of the bulk product, namely Temmler Pharma GmbH, Germany; Type I variations – change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of an API, or change of the manufacturer (including, where relevant, the quality control site) of an API – addition of a site where microbiological purity testing of the mother tincture Phytolacca americana O is performed; addition of a site where microbiological purity testing of the mother tincture Capsicum anuum D3 is performed; addition of a site where microbiological purity testing of the mother tincture Guaiacum D3 is performed; change of the name and address of the contract laboratory where control is performed for all mother tinctures (Phytolacca americana O, Capsicum D3 and Guaiacum D3); Type I variations – change in the test methods of an API or of a starting material/intermediate/reagent used in the manufacturing process of an API – minor changes to the method for the determination of aflatoxins in plant substances at the contract laboratory PhytoLab, namely, for the preparation of the "Reference solution for the recovery test" the volume of methanol was reduced by 50 % (V/V) from 5 mL to 1 mL; the method number was updated; applies to all plant substances. The aflatoxin test method used by PhytoLab was changed from SOP 805050_root, issue 4 to SOP 805021, issue 1. Minor changes occurred during the method update; applies to all APIs. The aflatoxin test method used by PhytoLab was changed from SOP 805050_fruit, issue 5 to SOP 805023, issue 1. Minor changes occurred during the method update; Type I variations – change in the re-test period/shelf life or storage conditions of an API – extension of the shelf life of the mother tincture Capsicum annuum D3 from 36 to 48 months based on real-time stability study results; extension of the shelf life of the mother tincture Guaiacum D3 from 36 to 48 months based on real-time stability study results; extension of the shelf life of the mother tincture Phytolacca americana O from 36 to 48 months based on real-time stability study results; Type I variations – change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a site where batch control/testing is performed); Type I variations – change in the shelf life or storage conditions of the finished medicinal product – change of the storage conditions of the medicinal product; Type I variations – changes related to the need to bring the product into compliance with a monograph of the SPhU or the European Pharmacopoeia, or another national pharmacopoeia of an EU Member State – bringing the specification of the mother tincture Capsicum annuum D3 into compliance with the HAB monograph and the monograph "Mother tinctures for homeopathic preparations"; bringing the specification of the mother tincture Phytolacca americana O into compliance with the HAB monograph and the monograph "Mother tinctures for homeopathic preparations"; bringing the specification of the mother tincture Guaiacum D3 into compliance with the HAB monograph and the monograph "Mother tinctures for homeopathic preparations"; Type I variations – change of the text of the labeling of the primary and secondary packaging; Type I variations – bringing the specification of the finished medicinal product for the "Microbiological purity" parameter into compliance with the requirements of the Ph. Eur.; Type I variations – change in the test methods of the finished medicinal product (minor change to approved test methods) |
without prescription |
UA/1838/01/01 |
|
WOOD SMALL-REED HERB |
herb (substance) in bags for the manufacture of non-sterile dosage forms |
LLC “NVK “Ecopharm” |
Ukraine |
LLC “NVK “Ecopharm” |
Ukraine |
amendment of registration materials: type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the applicant's address |
– |
UA/13368/01/01 |
|
TUFTED HAIRGRASS HERB |
herb (substance) in bags for the manufacture of non-sterile dosage forms |
LLC “NVK “Ecopharm” |
Ukraine |
LLC “NVK “Ecopharm” |
Ukraine |
amendment of registration materials: type I variations – Administrative changes. Change of the name and/or address of the applicant (registration certificate holder) – change of the applicant's address |
– |
UA/13369/01/01 |
|
TRACRIUM™ |
solution for injection, 10 mg/mL; 2,5 mL or 5 mL in an ampoule; 5 ampoules in a blister plastic pack in a cardboard box |
Aspen Pharma Trading Limited |
Ireland |
GlaxoSmithKline Manufacturing S.P.A. |
Italy |
amendments to registration materials: Type I changes – Administrative changes. Deletion of a manufacturing site (including sites for the API, intermediate or finished medicinal product, packaging sites, the manufacturer responsible for batch release, the site of batch control) or of a supplier of a starting material, reagent or excipient (if specified in the dossier) removal from the registration dossier materials of the alternative manufacturing site for the finished medicinal product GlaxoSmithKline Manufacturing S.P.A., Italy, responsible for sterility testing, located at the address: A. Fleming Street, 2 Verona, Italy / Via A. Fleming, 2 Verona, Italy. The approved manufacturing site located at Strada Provinciale Asolana N. 90 (loc. SAN POLO) 43056 Torrile (PR), Italy / Strada Provinciale Asolana N. 90 (loc. SAN POLO) 43056 TORRILE (PR), Italy, which performs the same function as the removed one, was retained. Type I changes – Administrative changes. Change in the name and/or address of the place of business of the manufacturer/importer of the finished medicinal product, including sites for batch release or quality control. (activity for which the manufacturer/importer is responsible, including batch release) change of the name and address of the manufacturer of the finished medicinal product GlaxoSmithKline Manufacturing S.P.A., Italy, without a change of the manufacturing site: Changes were made to the package leaflet regarding the name and location of the manufacturer, and, as a consequence, corresponding changes to the labeling text of the medicinal product packaging.
Implementation of changes within 6 months after approval |
by
prescription |
UA/4249/01/01 |
|
TRIGRIM |
tablets of 10 mg; 10 tablets per blister; 3 blisters per cardboard box |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
Pharmaceutical Plant “POLPHARMA” S.A. |
Poland |
amendments to registration materials: type I variations – changes concerning the deletion of the 2,5 mg and 5 mg strengths, entered in the summary of product characteristics of the medicinal product in the section “Composition” with corresponding changes in the sections “Main physical and chemical properties” and “Method of administration and doses”. Implementation of changes within 6 months after approval |
by
prescription |
UA/10564/01/03 |
|
FABRAZYME® |
powder for concentrate (5 mg/mL) for solution for infusion; 5 mg or 35 mg in a vial; 1 vial in a carton |
Genzyme Europe B.V. |
Netherlands |
Genzyme Ireland Limited, Ireland (manufacture of finished product (fill/finish), batch control, primary and secondary packaging, batch release authorization); Genzyme Limited, United Kingdom (secondary packaging, batch release authorization); Hospira Inc., United States of America (manufacture, primary packaging) |
Ireland/ United Kingdom/ United States of America |
amendments to the registration materials: Type I changes – change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the active pharmaceutical ingredient (API), or change of the manufacturer (including, where relevant, the quality control site) of the API – introduction of an alternative site for mycoplasma testing in cell culture in addition to the already approved site. Editorial corrections were made to section 3.2.S.2.1 manufacturer(s). 3.2.S.2.3 control of materials; Type I changes – changes in the manufacturing process of the API – changes in the manufacturing process of the API – for the establishment of a new working cell bank (WCB), an expansion of the roller bottle (RB) process from 25 RBs to 65 RBs is proposed; Type I changes – change in the test procedure of the API or of a starting material/intermediate/reagent used in the manufacturing process of the API – changes in the test procedures of the API – addition of an alternative DNA analysis method (DNA fingerprinting assay) for the working cell bank of Fabrazyme (WCB); Type I changes – change of the manufacturer of a starting material/intermediate/reagent used in the manufacturing process of the API, or change of the manufacturer (including, where relevant, the quality control site) of the API – addition of a site for storage of the Master Cell Bank and/or Working Cell Banks |
by
prescription |
UA/10306/01/01 |
|
FAMOTIDINE |
tablets, 20 mg; 10 tablets per blister; 2 blisters per pack |
PJSC “Kyivmedpreparat” |
Ukraine |
PJSC “Kyivmedpreparat” |
Ukraine |
amendments to registration materials:
type II variation – introduction of an additional API manufacturer (famotidine) |
by prescription |
UA/8118/01/01 |
|
FENTANYL M SANDOZ® |
transdermal patch, 25 mcg/h, 1 patch per sachet; 5 sachets per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Hexal AG |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10842/01/01 |
|
FENTANYL M SANDOZ® |
transdermal patch, 50 mcg/h, 1 patch per sachet; 5 sachets per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Hexal AG |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10842/01/02 |
|
FENTANYL M SANDOZ® |
transdermal patch, 75 mcg/h, 1 patch per sachet; 5 sachets per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Hexal AG |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10842/01/03 |
|
FENTANYL M SANDOZ® |
transdermal patch, 100 mcg/h, 1 patch per sachet; 5 sachets per box |
Sandoz Pharmaceuticals d.d. |
Slovenia |
Hexal AG |
Germany |
amendments to the registration materials: Type I changes – changes related to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) – change of the applicant's qualified person responsible for pharmacovigilance. Proposed wording: David J Lewis, B.Sc (Hons), Ph. D. Change of contact details of the applicant's qualified person responsible for pharmacovigilance. Change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Viacheslav Orlov. Change of contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Change of the location of the main pharmacovigilance activities. Change of the location of the pharmacovigilance system master file and its number |
by
prescription |
UA/10842/01/04 |
|
FIBRO-VEIN |
solution for injection 0,2%, 5 ml per vial; 10 vials per box |
STD Pharmaceutical Products Ltd |
Great Britain |
Siegfried Hameln GmbH, Germany (bulk product manufacturing, quality control and primary packaging); STD Pharmaceutical Products Ltd, United Kingdom (batch release); PharmaPak UK Ltd, United Kingdom (secondary packaging); Chester Medical Solutions, United Kingdom (secondary packaging) |
Germany/United Kingdom |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Daria Mykhailivna Pohodaieva. Change of the contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/12096/01/01 |
|
FIBRO-VEIN |
solution for injection 0,5%, 2 ml per ampoule; 5 ampoules per box |
STD Pharmaceutical Products Ltd |
Great Britain |
Siegfried Hameln GmbH, Germany (bulk product manufacturing, quality control and primary packaging); STD Pharmaceutical Products Ltd, United Kingdom (batch release); PharmaPak UK Ltd, United Kingdom (secondary packaging); Chester Medical Solutions, United Kingdom (secondary packaging) |
Germany/United Kingdom |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Daria Mykhailivna Pohodaieva. Change of the contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/12096/01/02 |
|
FIBRO-VEIN |
solution for injection 1%, 2 ml per ampoule; 5 ampoules per box |
STD Pharmaceutical Products Ltd |
Great Britain |
Siegfried Hameln GmbH, Germany (bulk product manufacturing, quality control and primary packaging); STD Pharmaceutical Products Ltd, United Kingdom (batch release); PharmaPak UK Ltd, United Kingdom (secondary packaging); Chester Medical Solutions, United Kingdom (secondary packaging) |
Germany/United Kingdom |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Daria Mykhailivna Pohodaieva. Change of the contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/12096/01/03 |
|
FIBRO-VEIN |
solution for injection 3%, 5 mL in a vial; 10 vials in a box; 2 mL in an ampoule; 5 ampoules in a box |
STD Pharmaceutical Products Ltd |
Great Britain |
Siegfried Hameln GmbH, Germany (bulk product manufacturing, quality control and primary packaging); STD Pharmaceutical Products Ltd, United Kingdom (batch release); PharmaPak UK Ltd, United Kingdom (secondary packaging); Chester Medical Solutions, United Kingdom (secondary packaging) |
Germany/United Kingdom |
amendments to registration materials:
Type I variations - changes relating to safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of a summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; of the applicant's pharmacovigilance contact person for carrying out pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes in the location of the pharmacovigilance system master file) - change of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine. Proposed wording: Daria Mykhailivna Pohodaieva. Change of the contact details of the contact person of the applicant's qualified person responsible for pharmacovigilance in Ukraine |
by prescription |
UA/12096/01/04 |
|
FINALGON® |
ointment, 20 g per tube; 1 tube complete with applicator per cardboard box |
LLC “Sanofi-Aventis Ukraine” |
Ukraine |
GLOBOPHARM Pharmazeutische Produktions- und Handelsgesellschaft m.b.H. |
Austria |
amendments to registration materials: Type I variations – Quality variations. Finished medicinal product. Manufacturing changes. Change of importer/changes concerning batch release and quality control of the finished medicinal product (replacement or addition of a manufacturer responsible for import and/or batch release) – Not including batch control/testing – replacement of the manufacturer responsible for batch release (not including batch control/testing) from Boehringer Ingelheim Pharma GmbH & Co. KG, Germany to GLOBOPHARM Pharmazeutische Produktions- und Handelsgesellschaft m.b.H., Austria. Changes have been made to the package leaflet regarding the name and location of the manufacturer, with corresponding changes to the labeling text of the medicinal product as a consequence. Implementation of the changes within 6 months after approval. |
without prescription |
UA/1909/01/01 |
|
FLUCONAZOLE-ZDOROV'YA |
hard capsules, 50 mg each; 7 or 10 capsules per blister; 1 blister per cardboard box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the applicant (registration certificate holder) – change of the applicant's address (Implementation of changes within 6 months after approval); Type I variations – Administrative changes. Change in the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control site (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturer, Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine, without changing the manufacturing site (Implementation of changes within 6 months after approval) |
by prescription |
UA/3938/01/01 |
|
FLUCONAZOLE-ZDOROV'YA |
hard capsules, 100 mg each; 7 or 10 capsules per blister; 1 blister per cardboard box |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the applicant (registration certificate holder) – change of the applicant's address (Implementation of changes within 6 months after approval); Type I variations – Administrative changes. Change in the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control site (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturer, Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine, without changing the manufacturing site (Implementation of changes within 6 months after approval) |
by prescription |
UA/3938/01/02 |
|
FLUCONAZOLE-ZDOROV'YA |
hard capsules, 150 mg each; 1 capsule per blister; 1, 2 or 3 blisters in a carton or 3 or 7 capsules per blister; 1 blister in a carton |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
Limited Liability Company “Pharmaceutical Company “Zdorovia” |
Ukraine |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the applicant (registration certificate holder) – change of the applicant's address (Implementation of changes within 6 months after approval); Type I variations – Administrative changes. Change in the name and/or address of the manufacturing site of the manufacturer/importer of the finished medicinal product, including batch release sites or quality control site (activity for which the manufacturer/importer is responsible, including batch release) – change of the address of the manufacturer, Limited Liability Company “Pharmaceutical Company “Zdorovia”, Ukraine, without changing the manufacturing site (Implementation of changes within 6 months after approval) |
No. 1 – over the counter; No. 2, No. 3, No. 7 – by prescription |
UA/3938/01/03 |
|
FLUOROURACIL- VISTA |
solution for injection 50 mg/mL; 5 mL or 10 mL, or 20 mL of solution for injection in vials; 1 vial in a cardboard box |
Mistral Capital Management Limited |
England |
Haupt Pharma Wolfratshausen GmbH |
Germany |
amendments to registration materials:
technical error in the labeling text on the secondary packaging of the medicinal product |
by prescription |
UA/15418/01/01 |
|
FONDAPARINUX SODIUM |
powder (substance) in double polyethylene bags for pharmaceutical use |
PJSC “Farmak” |
Ukraine |
BrightGene Pharmaceutical Co., Ltd., China;
DMF holder:
BrightGene Bio-Medical Technology Co., Ltd., China |
China |
amendments to registration materials: Type I variations – Administrative changes. Change of the name and/or address of the manufacturer (including, where applicable, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API (if specified in the medicinal product dossier) in the absence of a Certificate of Suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier). Addition of the name of the manufacturer of the API Fondaparinux sodium and indication of the address of the DMF holder (since the registration certificate, in the manufacturer section, states the name of the DMF holder Bright Gene Bio-Medical Technology Co., Ltd. and the address of the manufacturing site Building C25–C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China), without a change of the manufacturing site. |
– |
UA/17368/01/01 |
|
FRELSI® |
solution for injection 2,5 mg/0,5 mL, 0,5 mL in a syringe; 2 syringes in a blister; 1 or 5 blisters in a pack |
PJSC “Farmak” |
Ukraine |
PJSC “Farmak” |
Ukraine |
amendments to registration materials: Type I changes – change of the name and/or address of the manufacturer’s site of activity (including, where applicable, the quality control site), or of the holder of the active substance master file, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API – change of the name of the API manufacturer (Fondaparinux sodium). The manufacturing site and all manufacturing operations of the API remain unchanged |
by
prescription |
UA/17369/01/01 |
|
HEDERAL® IVY |
syrup, 115 mL or 200 mL in a vial, 1 vial with a measuring cup in a cardboard box |
PJSC “Vitaminy” |
Ukraine |
PJSC “VITAMINY” |
Ukraine |
amendments to registration materials: Type I changes – a change in the parameters of specifications and/or permitted limits specified in the specifications for the API, or for a starting/intermediate material/reagent used in the API manufacturing process (other changes); concomitant change: a change in the test methods for the API or starting material/intermediate/reagent used in the API manufacturing process (other changes in the test methods (including replacement or addition) for the API or starting/intermediate material) – changes to the specification and control method of the API ivy leaf dry extract “Finzelberg GmbH&Co.KG”, Germany, for the parameter “Identification”, due to the replacement of the kellin reference standard with the arbutin reference standard |
without
prescription |
UA/16495/01/01 |
|
CHONDROITIN SULFATE SODIUM |
powder (substance) in double polyethylene bags for pharmaceutical use |
PRJSC “FITOPHARM” |
Ukraine |
Bioiberica S.A.U. |
Spain |
amendments to registration materials: Type I variations – Administrative changes. Change in the name and/or address of the manufacturer's site of operation (including, where necessary, the quality control site), or of the API master file holder, or of the supplier of the API/starting material/reagent/intermediate used in the manufacture of the API (if specified in the medicinal product dossier) in the absence of a certificate of suitability to the European Pharmacopoeia in the approved dossier, or of the manufacturer of a new excipient (if specified in the dossier). Change of the address of the API manufacturer BIOIBERICA S.A., Spain, without changing the manufacturing site. |
– |
UA/15094/01/01 |
|
HOFITOL |
oral solution; 120 ml per vial; 1 vial per cardboard box |
Laboratoires Rosa-Phytopharma |
France |
Laboratoires Mayoly Spindler, France (manufacture of bulk product, primary and secondary packaging, quality control); Laboratoires Rosa-Phytopharma, France (responsible for batch release) |
France |
amendments to registration materials:
Type I variations – changes regarding safety/efficacy and pharmacovigilance. Introduction of or changes to the summary of the pharmacovigilance system (introduction of the summary of the pharmacovigilance system, change of the qualified person responsible for pharmacovigilance; the applicant's pharmacovigilance contact person for pharmacovigilance in Ukraine, if different from the qualified person responsible for pharmacovigilance (including contact details) and/or changes to the location of the pharmacovigilance system master file) - change of the qualified person responsible for pharmacovigilance:
Proposed wording: Kouessi LOWANOU. Change of contact details of the qualified person responsible for pharmacovigilance.
Change of the contact person responsible for pharmacovigilance: Proposed wording: Ihor Shkliarevych. Change of contact details of the contact person responsible for pharmacovigilance |
without prescription |
UA/8704/02/01 |
|
HOFITOL |
oral solution, 120 ml per vial; 1 vial per cardboard box |
Laboratoires Rosa-Phytopharma |
France |
Laboratoires Mayoly Spindler, France (manufacture of bulk product, primary and secondary packaging, quality control); Laboratoires Rosa-Phytopharma, France (responsible for batch release) |
France |
amendments to registration materials:
Type I variation – changes related to safety/efficacy and pharmacovigilance – replacement of the graphic design of the primary and secondary packaging with the packaging labeling text, with corresponding changes to the sections on quality control methods of the medicinal product (the section “Graphic design of the packaging” replaced with the section “Labeling”) |
without prescription |
UA/8704/02/01 |
|
HOFITOL |
oral solution, 120 ml per vial; 1 vial per cardboard box |
Laboratoires Rosa-Phytopharma |
France |
Laboratoires Mayoly Spindler, France (manufacture of bulk product, primary and secondary packaging, quality control); Laboratoires Rosa-Phytopharma, France (responsible for batch release) |
France |
amendments to registration materials:
Type I variations – safety/efficacy and pharmacovigilance changes – changes to the instruction for medical use of the medicinal product in the sections “Special warnings and precautions for use” and “Interaction with other medicinal products and other forms of interaction” (clarification of the ethanol content in the medicinal product) |
without prescription |
UA/8704/02/01 |
|
HUMULIN M3 |
suspension for injection, 100 IU/mL, 3 mL in a glass cartridge; 5 cartridges in a cardboard box; 3 mL in a glass cartridge; 1 cartridge in a QuinPen pen injector; 5 pen injectors in a cardboard box |
Lilly France |
France |
Lilly France |
France |
amendments to registration materials:
Type II variation – change in the primary packaging of the finished medicinal product – addition of an interchangeable sealing disc (a packaging component for cartridges). The material of the new sealing disc in contact with the medicinal product is chlorobutyl, whereas the material of the sealing disc used until now is bromobutyl |
by prescription |
UA/8567/01/01 |
|
HUMULIN REGULAR |
solution for injection, 100 IU/mL, 3 mL in a glass cartridge; 5 cartridges in a cardboard pack; 3 mL in a glass cartridge; 1 cartridge in a QuickPen pen; 5 pens in a cardboard pack |
Lilly France |
France |
Lilly France |
France |
amendments to registration materials:
Type II variation – change in the primary packaging of the finished medicinal product – addition of an interchangeable sealing disc (a packaging component for cartridges). The material of the new sealing disc in contact with the medicinal product is chlorobutyl, whereas the material of the sealing disc used until now is bromobutyl |
by prescription |
UA/8571/01/01 |
|
CEFINAC |
film-coated tablets, 200 mg each, 10 tablets per blister; 1 blister in a cardboard pack |
Abril Formulations Pvt. Ltd |
India |
Nectar Lifesciences Limited-Unit-VI |
India |
making changes to registration materials: Type I variations – change in the storage conditions of the finished medicinal product. Proposed wording: Store at a temperature not above 30°C in the original package |
by
prescription |
UA/16758/01/01 |
|
CEFINAC |
film-coated tablets, 400 mg each, 10 tablets per blister; 1 blister in a cardboard pack |
Abril Formulations Pvt. Ltd |
India |
Nectar Lifesciences Limited-Unit-VI |
India |
making changes to registration materials: Type I variations – change in the storage conditions of the finished medicinal product. Proposed wording: Store at a temperature not above 30°C in the original package |
by
prescription |
UA/16758/01/02 |
|
CYTERAL® |
film-coated tablets, 250 mg each, 10 tablets per blister; 1 blister in a cardboard pack |
ALKALOID AD Skopje |
Republic of Macedonia |
Alkaloid AD-Skopje |
Republic of Macedonia |
amendments to registration materials:
Type I variation – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 2000-405-Rev 09, R1-CEP 2000-405-Rev 10 for the active substance Ciprofloxacin Hydrochloride from the already approved manufacturer Neuland Laboratories Limited, India, resulting in a change of the CEP holder's address and of the API manufacturing site |
by prescription |
UA/1079/01/01 |
|
CYTERAL® |
film-coated tablets, 500 mg each, 10 tablets per blister; 1 blister in a cardboard pack |
ALKALOID AD Skopje |
Republic of Macedonia |
Alkaloid AD-Skopje |
Republic of Macedonia |
amendments to registration materials:
Type I variation – submission of an updated certificate of suitability to the European Pharmacopoeia No. R1-CEP 2000-405-Rev 09, R1-CEP 2000-405-Rev 10 for the active substance Ciprofloxacin Hydrochloride from the already approved manufacturer Neuland Laboratories Limited, India, resulting in a change of the CEP holder's address and of the API manufacturing site |
by prescription |
UA/1079/01/02 |
