2025 – Page 3 – State Expert Center of the Ministry of Health of Ukraine

Update of the safety information of medicinal products containing somatrogon (somatrogon), adopted by the PRAC committee during the review of signals discussed at the meeting of 01-04 September 2025

23.10.2025 295

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 registration materials/instructions for medical use of medicinal products containing finasteride and dutasteride

15.10.2025 526

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 roxadustat based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 7 – 10 July 2025

10.10.2025 425

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…

The European Medicines Agency (EMA) recommends measures to minimize the risk of suicidal thoughts with the use of medicinal products containing finasteride and dutasteride

10.10.2025 621

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 enfortumab vedotin (enfortumab vedotin) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

06.10.2025 399

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 semaglutide based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 02 – 05 June 2025

03.10.2025 870

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 domperidone (domperidone)

02.10.2025 738

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 isoniazid (isoniazid)

23.09.2025 436

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 vaccines for the prevention of varicella; measles, mumps, rubella, and varicella (live), adopted by the PRAC committee during the review of signals discussed at the meeting of 07-10 July 2025

22.09.2025 718

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…

Updates to the safety information of medicinal products containing clozapine adopted by PRAC during the review of signals discussed at the meeting of July 07-10, 2025

22.09.2025 661

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 the safety information of medicinal products containing somatrogon (somatrogon), adopted by the PRAC committee during the review of signals discussed at the meeting of 01-04 September 2025

Regarding amendments to the registration materials/instructions for medical use of medicinal products containing finasteride and dutasteride

Changes to the safety information on medicinal products containing roxadustat based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 7 – 10 July 2025

The European Medicines Agency (EMA) recommends measures to minimize the risk of suicidal thoughts with the use of medicinal products containing finasteride and dutasteride

Changes to the safety information of medicinal products containing enfortumab vedotin (enfortumab vedotin) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

Changes to the safety information on medicinal products containing semaglutide based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 02 – 05 June 2025

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

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

Update of safety information on vaccines for the prevention of varicella; measles, mumps, rubella, and varicella (live), adopted by the PRAC committee during the review of signals discussed at the meeting of 07-10 July 2025

Updates to the safety information of medicinal products containing clozapine adopted by PRAC during the review of signals discussed at the meeting of July 07-10, 2025

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