Latest updates

06yellow 2026

List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026

20 #For applicants #List of applications for state registration of medicinal products

List of registration forms submitted for state re-registration during 28.09.2026–02.10.2026. Contains data on the application date, trade name, INN, dosage form and applicant for medicinal products intended for re-registration in Ukraine. generated automatically

06yellow 2026

List of registration forms submitted for state registration in the period from 28.09.2026 to 02.10.2026

26 #For applicants #List of applications for state registration of medicinal products

List of registration forms submitted for state registration during 28.09.2026–02.10.2026. Contains data on the application date, trade name, INN, dosage form and applicant for medicinal products intended for registration in Ukraine. generated automatically

06yellow 2026

Registration certificates to order No. 1405

37 #For applicants #Information on signed registration certificates

Signed registration certificates, inserts to registration certificates and letters in accordance with order of the Ministry of Health of Ukraine No. 1405 dated 24.09.2026 have been received. Checklists…

06yellow 2026

Registration certificates to order No. 1340

33 #For applicants #Information on signed registration certificates

Signed registration certificates, inserts to registration certificates and letters in accordance with order of the Ministry of Health of Ukraine No. 1340 dated 11.09.2026 have been received. Checklists…

05yellow 2026

Daglyph® Duo clinical part I

74

Clinical trial report on the bioequivalence of the generic medicinal product dapagliflozin/metformin hydrochloride 5 mg/1000 mg in the form of film-coated tablets, manufactured by PJSC Farmak. The study was conducted with the participation of healthy volunteers under fasting conditions to confirm bioequivalence to the reference product. generated automatically

05yellow 2026

On amendments to the instructions for medical use of medicinal products containing angiotensin-converting enzyme inhibitors

100 #For applicants #Pharmacovigilance #EMA #2026

The State Expert Center of the Ministry of Health of Ukraine reminds holders of registration certificates of the need to check and, if necessary, make the relevant changes to…

05yellow 2026

On amendments to the instructions for medical use of medicinal products containing angiotensin-converting enzyme inhibitors

53 #For doctors #Pharmacovigilance #EMA #2026

The State Expert Center of the Ministry of Health of Ukraine reminds holders of registration certificates of the need to check and, if necessary, make the relevant changes to…

05yellow 2026

OZLAM

33

Report on preclinical studies and report on a clinical trial of the generic medicinal product apremilast in tablet form. Contains a review of preclinical data based on scientific literature and the results of a bioequivalence study. compiled automatically

05yellow 2026

LENVATINIB-VISTA

35

Report on preclinical and clinical studies of the generic medicinal product in the form of hard capsules. Contains justification for the absence of preclinical studies and the results of an open-label randomised crossover bioequivalence study involving healthy male volunteers. compiled automatically

05yellow 2026

KOLKHIMED_clinical

35

Report on a clinical trial of a medicinal product in the form of a solution for injection submitted for state registration. Contains data on the applicant, the manufacturer, justification for the absence of bioequivalence studies for the generic product and a conclusion. compiled automatically

05yellow 2026

KOLKHIMED_preclinical

44

Preclinical study report of a medicinal product submitted as an annex to the registration materials. Contains data on pharmacology, pharmacokinetics and toxicology; for a generic product, preclinical studies are not required. compiled automatically

05yellow 2026

APIXABAN GEDEON RICHTER

32

Preclinical study report and clinical bioequivalence trial report of a generic medicinal product based on apixaban in tablet form. The document contains a review of pharmacological, pharmacokinetic and toxicological data, as well as the results of a bioequivalence study with the comparator product. compiled automatically

05yellow 2026

AIGLIP-PHARMAK_clinic

26

Clinical trial report of a generic medicinal product containing data on the proof of bioequivalence, design, inclusion criteria, efficacy and safety results. Intended for specialists who evaluate registration materials. compiled automatically

05yellow 2026

AIGLIP-PHARMAK_preclinical

40

Preclinical study report of a generic medicinal product in tablet form developed as a generic of the reference product. No own preclinical studies were conducted; instead, the results of studies of the reference product are provided. compiled automatically

05yellow 2026

ADERMIX

35

Report on preclinical studies of a hybrid medicinal product, stating that no own toxicological and pharmacological tests were conducted and none are required. It also contains a clinical trial report indicating the applicant, manufacturers and information on the studies conducted. compiled automatically

05yellow 2026

CLOMAX

21

Report on preclinical studies and a clinical trial report for a medicinal product in the form of a shampoo registered as a hybrid medicinal product. No own studies were conducted; instead, materials on pharmaceutical equivalence and a scientific bibliography on safety and efficacy assessment were submitted. compiled automatically

05yellow 2026

EMBOXA_clinic 3

21

Report on a bioequivalence clinical trial of a generic medicinal product of rivaroxaban in the form of crushed tablets compared with the reference product. A phase I study was conducted in healthy adult volunteers in Canada. compiled automatically

05yellow 2026

EMBOXA_clinic 2

24

Report on a bioequivalence clinical trial of a generic medicinal product of rivaroxaban in the form of tablets compared with the reference product. A phase I study was conducted in healthy volunteers to confirm bioequivalence and assess safety. compiled automatically

05yellow 2026

EMBOXA_clinic 1

24

Report on a clinical trial of bioequivalence of a generic medicinal product in tablet form compared with the reference product. The document contains a description of the study design, inclusion criteria, methods for assessing efficacy and safety, demographic indicators and results. compiled automatically

05yellow 2026

EMBOX_ preclinical

21

Report on preclinical studies of a generic medicinal product, which states that own preclinical studies are not submitted due to the proven therapeutic equivalence to the reference product, and all sections of pharmacology, pharmacokinetics and toxicology are marked as not conducted. compiled automatically

05yellow 2026

Daglyf® Duo clinical part II

23

Report on a clinical trial of bioequivalence of the generic medicinal product dapagliflozin/metformin hydrochloride, tablets 5 mg/850 mg, in healthy volunteers. The study confirms bioequivalence to the reference product and provides data on safety and tolerability. compiled automatically

05yellow 2026

Daglyf® Duo preclinical

23

Report on preclinical studies of a generic medicinal product in the form of film-coated tablets. It contains information on the absence of own preclinical studies and the submission of study results of the reference product in accordance with legal requirements. compiled automatically

02yellow 2026

Information letter-appeal to healthcare professionals on the safety of use of the medicinal product KONTROLFLEKS (tiocolchicoside). Important information on the risk of genotoxicity

73 #For doctors #Pharmacovigilance #Letters — appeals to healthcare and pharmaceutical professionals #2026

Information letter-notification for healthcare professionals on the potential risk of genotoxicity (aneuploidy) with the use of tiocolchicoside, in particular embryotoxic and teratogenic effects. Contains contraindications regarding pregnancy, breastfeeding and contraception, as well as recommendations on dosage and duration of treatment. compiled automatically

02yellow 2026

Registration certificates to order No. 1315

112 #For applicants #Information on signed registration certificates

Signed registration certificates, inserts to registration certificates and letters in accordance with order of the Ministry of Health of Ukraine No. 1315 dated 07.09.2026 have been received. Checklists…

02yellow 2026

Order of the Ministry of Health of Ukraine of 24 September 2026 No. 1405

114 #For applicants #MoH orders on registration and re-registration of medicinal products

Order of the Ministry of Health of Ukraine of 24.09.2026 No. 1405 on state registration, re-registration of medicinal products and medical immunobiological preparations and amendments to their registration materials. Contains lists of preparations entered into the State Register of Medicinal Products. compiled automatically

02yellow 2026

Order of the Ministry of Health of Ukraine of 22 September 2026 No. 1383

86 #For applicants #MoH orders on registration and re-registration of medicinal products

Order of the Ministry of Health of Ukraine dated 22.09.2026 No. 1383 on state re-registration of medicinal products (medical immunobiological preparations) registered by the competent authorities of the USA, Great Britain, Switzerland, Japan, Australia, Canada and the EU, and amendments to their registration materials. The annexes contain lists of re-registered products and changes made to the State Register of Medicinal Products. compiled automatically

02yellow 2026

List of medicinal products for which the authenticity expert evaluation has been completed (25.09.2026)

50 #For applicants #Lists of medicinal products for which the expert evaluation of the authenticity of registration materials has been completed

List of medicinal products for which the verification of registration materials for authenticity has been completed. Intended for procurement by authorized persons in the field of healthcare; contains data on products, applicants, manufacturers and registration procedures. compiled automatically

02yellow 2026

Order of the Ministry of Health of Ukraine of 30 September 2026 No. 1445

34 #For applicants #Orders on certification of the plasma master file

Order of the Ministry of Health of Ukraine on amendments to the certified plasma master file for medicinal products manufactured from human blood or blood plasma. The amendments concern the addition of new places of activity of subjects of the blood system. compiled automatically

02yellow 2026

Order of the Ministry of Health of Ukraine of 30 September 2026 No. 1454

76 #For applicants #MoH orders on registration and re-registration of medicinal products

Order of the Ministry of Health of Ukraine of 30 September 2026 No. 1454 on state registration, re-registration of medicinal products and medical immunobiological preparations, amendments to registration materials, as well as refusal of registration. Contains lists of registered, re-registered products, amended materials and refusals, intended for pharmaceutical manufacturers, applicants and industry professionals. compiled automatically

01yellow 2026

List of registration forms submitted for state registration in the period from 21.09.2026 to 25.09.2026

95 #For applicants #List of applications for state registration of medicinal products

List of registration forms submitted for state registration in the period from 21.09.2026 to 25.09.2026. Contains application dates, trade names, INNs, dosage forms and applicants of medicinal products. compiled automatically

01yellow 2026

Information letter-appeal to healthcare professionals regarding the safety of use of the medicinal products LEVOFLOXACIN and LEFSAN. Systemic antibacterial agents of the fluoroquinolone group, risk of long-term serious adverse reactions, reminder of restrictions on use

59 #For doctors #Pharmacovigilance #Letters — appeals to healthcare and pharmaceutical professionals #2026

Information letter-appeal for healthcare professionals on the safety of systemic fluoroquinolones: a reminder about restrictions on prescribing due to the risk of long-term serious adverse reactions and the procedure for reporting them. compiled automatically

01yellow 2026

Information letter-appeal to healthcare professionals regarding the medicinal product PARACETAMOL-BAXTER. Dosing tool, minimisation of the occurrence of a medication error leading to accidental overdose due to confusion between the units of measurement mg and ml

71 #For doctors #Pharmacovigilance #Letters — appeals to healthcare and pharmaceutical professionals #2026

Information letter-appeal for healthcare professionals regarding the safe use of a paracetamol-based medicinal product for infusion. Contains a dosing table depending on body weight and a dose calculation tool for the purpose of minimising the risk of accidental overdose due to confusion between mg and ml. compiled automatically

01yellow 2026

List of medicinal products for which the authenticity expert evaluation has been completed (04.09.2026)

59 #For applicants #Lists of medicinal products for which the expert evaluation of the authenticity of registration materials has been completed

List of medicinal products for which the verification of registration materials for authenticity has been completed for further procurement by the authorised person in the field of healthcare. Contains data on applicants, manufacturers, registration procedures and certificate numbers. compiled automatically

01yellow 2026

Tiara A® updated

55

Preclinical study report and clinical trial report of a generic medicinal product in the form of film-coated tablets. Contains the justification for the absence of preclinical studies and the results of a bioequivalence study involving healthy volunteers. compiled automatically

01yellow 2026

CONCLUSION ON THE RESULTS OF THE EXPERT EVALUATION OF CHANGES TO THE MASTER FILE FOR PLASMA FOR MEDICINAL PRODUCTS MANUFACTURED FROM HUMAN BLOOD OR HUMAN BLOOD PLASMA HAS BEEN SUBMITTED TO THE MOH, APPLICANT (HOLDER OF THE PMF) – BIOFARMA PLASMA LLC, UKRAINE (21.09.2026)

45 #For applicants #Certain procedures are provided for by the procedure for conducting expert evaluation of registration materials for medicinal products of 26 August 2005 No. 426

The conclusion of the expert evaluation of changes to the master file for plasma for medicinal products manufactured from human blood or human blood plasma has been submitted to the MoH. The document concerns the applicant — BIOFARMA PLASMA LLC, Ukraine. generated automatically

01yellow 2026

List of medicinal products registered by competent authorities (21.09.2026)

52 #For applicants #Lists of medicinal products registered by competent authorities

List of medicinal products registered by the competent authorities of the USA, Great Britain, Switzerland, Japan, Australia, Canada and the EU, for which the review of materials on amendments during the validity of the registration certificate has been completed. Contains data on applicants, manufacturers, dosage forms, registration procedures and certificate numbers. generated automatically

01yellow 2026

List of medicinal products submitted to the MoH (21.09.2026)

163 #For applicants #List of medicinal products recommended for registration, re-registration and amendments to registration materials

Annex to the order of the Ministry of Health of Ukraine — a list of medicinal products proposed for state registration, indicating names, dosage forms, applicants, manufacturers and registration procedures. Intended to inform interested parties about the products submitted for registration. compiled automatically

01yellow 2026

Order of the Ministry of Health of Ukraine of 15 September 2026 No. 1356

69 #For applicants #Expert evaluation of preclinical and clinical trial materials #MoH orders on conducting clinical trials / substantial amendments

Order of the Ministry of Health of Ukraine of 15.09.2026 No. 1356 permits the conduct of a clinical trial of a medicinal product and approves substantial amendments to clinical trial protocols in accordance with the annexes. The document concerns applicants, sponsors, investigators and healthcare institutions involved in these trials. compiled automatically

30ver. 2026

List of substantial amendments to clinical trial protocols NER No. 31, NTR No. 37 of 17.09.2026

116 #For applicants #Expert evaluation of preclinical and clinical trial materials #List of clinical trial protocols of medicinal products recommended for approval by the MoH

The appendix to decision of the SEC No. 31 and the STC No. 37 dated 17.09.2026 contains a list of protocols of clinical trials of medicinal products and substantial amendments thereto that received positive conclusions of experts. It is intended for applicants, sponsors and investigators participating in these trials. compiled automatically

30ver. 2026

Order of the Ministry of Health of Ukraine of 14 September 2026 No. 1346

82 #For applicants #Expert evaluation of preclinical and clinical trial materials #MoH orders on conducting clinical trials / substantial amendments

Order of the Ministry of Health of Ukraine on the complete early termination of the patient access programme to the investigational medicinal product after completion of the clinical trial, approved by MoH order No. 1831 of 02 December 2025. generated automatically

30ver. 2026

Order of the Ministry of Health of Ukraine of 23 September 2026 No. 1399

88 #For applicants #Expert evaluation of preclinical and clinical trial materials #MoH orders on conducting clinical trials / substantial amendments

Order of the Ministry of Health of Ukraine dated 23.09.2026 No. 1399 permits the conduct of clinical trials of medicinal products and approves substantial amendments to the protocols of such trials in accordance with the annexes. The document concerns applicants, sponsors, investigators and healthcare institutions involved in these studies. compiled automatically

30ver. 2026

Synrise, powder and solvent for solution for injection, Takeda Manufacturing Austria AG, Austria

48 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for the medicinal product Cinryze (human C1 esterase inhibitor), version 11.2 dated 31 March 2025. The document describes important risks, measures for their minimisation and methods for obtaining additional information, as well as indications for use for the treatment and prevention of hereditary angioedema. compiled automatically

30ver. 2026

Altreno, lotion, Bausch Health LLC, Ukraine

52 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product for the treatment of acne in adults, adolescents and children from 9 years of age. Important risks, measures for their minimisation and methods for obtaining additional safety information are described. compiled automatically

30ver. 2026

Ticagrelor-Teva, film-coated tablets, Teva Ukraine LLC, Ukraine

46 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for the medicinal product Ticagrelor-Teva (tablets 60 mg and 90 mg): important risks in use, measures for their minimisation and missing information are described. Intended for healthcare professionals and patients. compiled automatically

30ver. 2026

Fersinol, solution for injection, WORLD MEDICINE LLC, Ukraine

49 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on iron (III) hydroxide polymaltose complex for parenteral use in iron-deficiency anaemia. The document describes the important risks of the medicinal product, measures for their minimisation and further pharmacovigilance. compiled automatically

30ver. 2026

Seknidoks, film-coated tablets, WORLD MEDICINE LLC, Ukraine

48 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on secnidazole in the form of tablets of 1,0 g: the indications for use, important risks, measures for their minimisation and further monitoring are described. The document is intended for healthcare professionals and patients. compiled automatically

30ver. 2026

Bilastine-Darnytsia, tablets, PJSC "Pharmaceutical Firm "Darnytsia"

54 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for the medicinal product Bilastine-Darnytsia, tablets, 20 mg, containing bilastine. The document describes the important risks of the product, measures for their minimisation and planned studies to obtain additional safety information. compiled automatically

30ver. 2026

Feiba, powder and solvent for solution for infusion, Takeda Manufacturing Austria AG, Austria

51 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for the medicinal product Feiba (human plasma protein with activity that bypasses factor VIII inhibitors), version 13.0. The document describes the important risks of the product, measures for their minimisation and monitoring, and is intended for healthcare professionals and patients. compiled automatically

30ver. 2026

Apolitset, tablets, PJSC "Pharmaceutical Firm "Darnytsia"

62 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on levocetirizine dihydrochloride for the symptomatic treatment of allergic rhinitis and urticaria in adults and children from 6 years of age. Contains an overview of the epidemiology of the diseases and a summary of the results of clinical studies of efficacy and safety. compiled automatically

30ver. 2026

Blokpain, solution for injection, PJSC "Lekhim-Kharkiv"

40 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for the medicinal product Blokpain, solution for injection, manufactured by PJSC "Lekhim-Kharkiv". The document contains an overview of the epidemiology of postoperative pain, results of literature data on the efficacy and safety of ketorolac in the relief of acute pain, and a statement of the absence of unknown data on treatment efficacy. compiled automatically

30ver. 2026

Aranesp, solution for injection, Amgen Europe B.V., the Netherlands

42 #For patients #Pharmacovigilance #PSUR summary #2026

This is a summary of the risk management plan for a medicinal product containing darbepoetin alfa. The document describes the important risks of use, measures for their minimisation and planned studies to obtain additional safety information. compiled automatically

30ver. 2026

ICSJEVA®, solution for injection, Amgen Europe B.V., the Netherlands

45 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on denosumab, intended for the prevention of bone complications in oncology patients. The document describes the important risks of the medicinal product, measures for their minimisation and planned studies to obtain additional information. compiled automatically

30ver. 2026

Alfort Stick, oral solution, Delta Medical Promotions AG, Switzerland

39 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product for short-term symptomatic treatment of acute pain of mild and moderate intensity (musculoskeletal pain, dysmenorrhoea, toothache) in adults; contains an overview of the epidemiology of these conditions. compiled automatically

30ver. 2026

Diclomax forte, gel, INFARMA Trading LLC, Republic of Latvia

44 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for diclofenac diethylamine gel 23,2 mg/g indicated for the treatment of muscle and joint injuries, localized rheumatism and mild arthritis. The document describes important risks, measures for their minimization and routine pharmacovigilance activities. compiled automatically

30ver. 2026

Reagila, capsules, JSC "Gedeon Richter"

36 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product for the treatment of schizophrenia in adults, containing a description of important risks, measures for their minimization and missing information. Intended for healthcare professionals and patients. compiled automatically

30ver. 2026

Tonzihelp, oromucosal spray, Ananta Medicare Ltd., Great Britain

40 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on benzydamine in the form of an oromucosal spray indicated for the symptomatic treatment of inflammations of the oropharynx, pain in gingivitis, stomatitis, pharyngitis and in dentistry. The document describes important risks, measures for their minimization and routine pharmacovigilance activities. compiled automatically

30ver. 2026

TIARA A®, film-coated tablets, PJSC "Pharmaceutical Firm "Darnytsia"

31 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product for the treatment of essential hypertension in adults, containing amlodipine besylate and valsartan. The document describes important risks, measures for their minimisation and routine pharmacovigilance activities. compiled automatically

30ver. 2026

Quetiapine-Darnytsia, film-coated tablets, PJSC “Pharmaceutical Firm “Darnytsia”

36 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on quetiapine in the form of film-coated tablets intended for the treatment of schizophrenia and bipolar disorders. The document describes important risks, measures for their minimisation and routine pharmacovigilance activities. compiled automatically

30ver. 2026

Eurofast Combo, soft capsules, Euro Lifecare Private Limited, India

34 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on ibuprofen and paracetamol intended for the symptomatic treatment of pain of various origins and fever. The document describes important risks, measures for their minimisation and routine pharmacovigilance activities. compiled automatically

30ver. 2026

HELPEX® LAR, throat rinse, solution, Mowi Health GmbH

33 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product for gargling based on chlorhexidine and benzydamine, intended for the treatment of inflammatory and infectious diseases of the oral cavity and pharynx. The document describes important risks, measures for their minimisation and routine pharmacovigilance activities. compiled automatically

30ver. 2026

Lornado, lyophilisate for solution for injection, WORLD MEDICINE LLC, Ukraine

34 #For patients #Pharmacovigilance #PSUR summary #2026

Summary of the risk management plan for a medicinal product based on lornoxicam for parenteral use, intended for short-term symptomatic treatment of acute pain of mild and moderate severity in adults. The document describes important risks, measures for their minimisation and further monitoring. compiled automatically

30ver. 2026

Registration certificates to order No. 1279

89 #For applicants #Information on signed registration certificates

Signed registration certificates, inserts to registration certificates and letters in accordance with order of the Ministry of Health of Ukraine No. 1279 dated 02.09.2026 have been received. Checklists…

30ver. 2026

Registration certificates to order No. 1219

68 #For applicants #Information on signed registration certificates

Signed registration certificates, inserts to registration certificates and letters in accordance with order of the Ministry of Health of Ukraine No. 1219 dated 27.08.2026 have been received. Checklists…

30ver. 2026

Information letter-appeal to healthcare professionals regarding the safety of use of the medicinal products LEVOFLOXACIN and LEFSAN. Important information on minimising the risk of aortic aneurysm and dissection and cardiac valve regurgitation/insufficiency with the use of systemic and inhaled fluoroquinolones

47 #For doctors #Pharmacovigilance #Letters — appeals to healthcare and pharmaceutical professionals #2026

Information letter-appeal for healthcare professionals on the safety of systemic and inhaled fluoroquinolones: reminder of restrictions on use due to the risk of aortic aneurysm and dissection, cardiac valve regurgitation/insufficiency and other serious adverse reactions. Contains recommendations on prescribing, counselling patients and reporting adverse reactions. compiled automatically

30ver. 2026

On amendments to the instructions for medical use of medicinal products containing phenylephrine / tropicamide (phenylephrine / tropicamide)

65 #For doctors #Pharmacovigilance #EMA #2026

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

30ver. 2026

On amendments to the instructions for medical use of medicinal products containing phenylephrine / tropicamide (phenylephrine / tropicamide)

67 #For applicants #Pharmacovigilance #EMA #2026

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

29ver. 2026

Information letter-appeal to healthcare professionals on the safety of use of the medicinal product DEXMEDETOMIDINE B.BRAUN (dexmedetomidine hydrochloride). Increased risk of mortality in intensive care unit patients aged ≤ 65 years

56 #For doctors #Pharmacovigilance #Letters — appeals to healthcare and pharmaceutical professionals #2026

Information letter-appeal for healthcare professionals on the increased risk of mortality in intensive care unit patients under 65 years of age when using dexmedetomidine, based on the results of the SPICE III study. Contains a description of the evidence, risk factors and an update to the instructions for medical use. compiled automatically

28ver. 2026

ORDER No.265 dated 23.09.2026 On Amendments to the Regulation on the Expert Committee on Health Technology Assessment of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine"

111

Order of the State Expert Center of the Ministry of Health of Ukraine approving the updated version of the Regulation on the Expert Committee for Health Technology Assessment. The document defines the legal and organizational principles of the committee's activity, its tasks and powers regarding providing recommendations on the inclusion of medicinal products in the National List and the lists of state procurement. compiled automatically

List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026

List of registration forms submitted for state registration in the period from 28.09.2026 to 02.10.2026

Registration certificates to order No. 1405

Registration certificates to order No. 1340

Daglyph® Duo clinical part I

On amendments to the instructions for medical use of medicinal products containing angiotensin-converting enzyme inhibitors

On amendments to the instructions for medical use of medicinal products containing angiotensin-converting enzyme inhibitors

OZLAM

LENVATINIB-VISTA

KOLKHIMED_clinical

KOLKHIMED_preclinical

APIXABAN GEDEON RICHTER

AIGLIP-PHARMAK_clinic

AIGLIP-PHARMAK_preclinical

ADERMIX

CLOMAX

EMBOXA_clinic 3

EMBOXA_clinic 2

EMBOXA_clinic 1

EMBOX_ preclinical

Daglyf® Duo clinical part II

Daglyf® Duo preclinical

Information letter-appeal to healthcare professionals on the safety of use of the medicinal product KONTROLFLEKS (tiocolchicoside). Important information on the risk of genotoxicity

Registration certificates to order No. 1315

Order of the Ministry of Health of Ukraine of 24 September 2026 No. 1405

Order of the Ministry of Health of Ukraine of 22 September 2026 No. 1383

List of medicinal products for which the authenticity expert evaluation has been completed (25.09.2026)

Order of the Ministry of Health of Ukraine of 30 September 2026 No. 1445

Order of the Ministry of Health of Ukraine of 30 September 2026 No. 1454

List of registration forms submitted for state registration in the period from 21.09.2026 to 25.09.2026

Information letter-appeal to healthcare professionals regarding the safety of use of the medicinal products LEVOFLOXACIN and LEFSAN. Systemic antibacterial agents of the fluoroquinolone group, risk of long-term serious adverse reactions, reminder of restrictions on use

Information letter-appeal to healthcare professionals regarding the medicinal product PARACETAMOL-BAXTER. Dosing tool, minimisation of the occurrence of a medication error leading to accidental overdose due to confusion between the units of measurement mg and ml

List of medicinal products for which the authenticity expert evaluation has been completed (04.09.2026)

Tiara A® updated

CONCLUSION ON THE RESULTS OF THE EXPERT EVALUATION OF CHANGES TO THE MASTER FILE FOR PLASMA FOR MEDICINAL PRODUCTS MANUFACTURED FROM HUMAN BLOOD OR HUMAN BLOOD PLASMA HAS BEEN SUBMITTED TO THE MOH, APPLICANT (HOLDER OF THE PMF) – BIOFARMA PLASMA LLC, UKRAINE (21.09.2026)

List of medicinal products registered by competent authorities (21.09.2026)

List of medicinal products submitted to the MoH (21.09.2026)

Order of the Ministry of Health of Ukraine of 15 September 2026 No. 1356

List of substantial amendments to clinical trial protocols NER No. 31, NTR No. 37 of 17.09.2026

Order of the Ministry of Health of Ukraine of 14 September 2026 No. 1346

Order of the Ministry of Health of Ukraine of 23 September 2026 No. 1399

Synrise, powder and solvent for solution for injection, Takeda Manufacturing Austria AG, Austria

Altreno, lotion, Bausch Health LLC, Ukraine

Ticagrelor-Teva, film-coated tablets, Teva Ukraine LLC, Ukraine

Fersinol, solution for injection, WORLD MEDICINE LLC, Ukraine

Seknidoks, film-coated tablets, WORLD MEDICINE LLC, Ukraine

Bilastine-Darnytsia, tablets, PJSC "Pharmaceutical Firm "Darnytsia"

Feiba, powder and solvent for solution for infusion, Takeda Manufacturing Austria AG, Austria

Apolitset, tablets, PJSC "Pharmaceutical Firm "Darnytsia"

Blokpain, solution for injection, PJSC "Lekhim-Kharkiv"

Aranesp, solution for injection, Amgen Europe B.V., the Netherlands

ICSJEVA®, solution for injection, Amgen Europe B.V., the Netherlands

Alfort Stick, oral solution, Delta Medical Promotions AG, Switzerland

Diclomax forte, gel, INFARMA Trading LLC, Republic of Latvia

Reagila, capsules, JSC "Gedeon Richter"

Tonzihelp, oromucosal spray, Ananta Medicare Ltd., Great Britain

TIARA A®, film-coated tablets, PJSC "Pharmaceutical Firm "Darnytsia"

Quetiapine-Darnytsia, film-coated tablets, PJSC “Pharmaceutical Firm “Darnytsia”

Eurofast Combo, soft capsules, Euro Lifecare Private Limited, India

HELPEX® LAR, throat rinse, solution, Mowi Health GmbH

Lornado, lyophilisate for solution for injection, WORLD MEDICINE LLC, Ukraine

Registration certificates to order No. 1279

Registration certificates to order No. 1219

On amendments to the instructions for medical use of medicinal products containing phenylephrine / tropicamide (phenylephrine / tropicamide)

On amendments to the instructions for medical use of medicinal products containing phenylephrine / tropicamide (phenylephrine / tropicamide)

Information letter-appeal to healthcare professionals on the safety of use of the medicinal product DEXMEDETOMIDINE B.BRAUN (dexmedetomidine hydrochloride). Increased risk of mortality in intensive care unit patients aged ≤ 65 years

ORDER No.265 dated 23.09.2026 On Amendments to the Regulation on the Expert Committee on Health Technology Assessment of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine"

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