2023 – Page 4 – State Expert Center of the Ministry of Health of Ukraine

Changes to the safety information of medicinal products containing sacubitril/valsartan (sacubitril/valsartan) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 13-16 March 2023

27.07.2023 1032

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…

Changes to the safety information of medicinal products containing palbociclib (palbociclib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 13-16 March 2023

27.07.2023 1192

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…

Regarding amendments to the instructions for medical use of medicinal products containing fenoterol (fenoterol) (for the treatment of respiratory disorders)

21.07.2023 1234

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…

Regarding amendments to the instructions for medical use of medicinal products containing carbidopa/levodopa (carbidopa/levodopa)

20.07.2023 948

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…

Update of safety information on tofacitinib-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 5-8 June 2023

20.07.2023 1005

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…

Regarding amendments to the instructions for medical use of medicinal products containing ropivacaine (ropivacaine)

14.07.2023 1109

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…

Changes to the safety information of medicinal products containing roxadustat following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of July 4-7, 2022

07.07.2023 1209

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…

Changes to the safety information of medicinal products containing cabozantinib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 4 – 7 July 2022

07.07.2023 759

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…

Changes to the safety information on medicinal products containing osimertinib based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 4 – 7 July 2022

07.07.2023 595

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…

Regarding amendments to the instructions for medical use of medicinal products containing famotidine (famotidine)

03.07.2023 1315

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…

Changes to the safety information of medicinal products containing sacubitril/valsartan (sacubitril/valsartan) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 13-16 March 2023

Changes to the safety information of medicinal products containing palbociclib (palbociclib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 13-16 March 2023

Regarding amendments to the instructions for medical use of medicinal products containing fenoterol (fenoterol) (for the treatment of respiratory disorders)

Regarding amendments to the instructions for medical use of medicinal products containing carbidopa/levodopa (carbidopa/levodopa)

Update of safety information on tofacitinib-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 5-8 June 2023

Regarding amendments to the instructions for medical use of medicinal products containing ropivacaine (ropivacaine)

Changes to the safety information of medicinal products containing roxadustat following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of July 4-7, 2022

Changes to the safety information of medicinal products containing cabozantinib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 4 – 7 July 2022

Changes to the safety information on medicinal products containing osimertinib based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 4 – 7 July 2022

Regarding amendments to the instructions for medical use of medicinal products containing famotidine (famotidine)

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