2023 – Page 2 – State Expert Center of the Ministry of Health of Ukraine

Changes to the safety information of medicinal products containing nintedanib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of June 05-08, 2023

07.11.2023 1172

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 rituximab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of June 05-08, 2023

07.11.2023 1662

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 for medicinal products containing aprotinin based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

03.11.2023 2138

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 nirmatrelvir, ritonavir (nirmatrelvir, ritonavir) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

01.11.2023 2319

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 Pharmacovigilance Risk Assessment Committee (PRAC) recommends new safety measures to avoid exposure to medicinal products containing topiramate during pregnancy

31.10.2023 1428

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…

Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and grounds for amending the registration materials of medicinal products containing sildenafil (sildenafil)

25.10.2023 2695

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 aflibercept following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of July 03-06, 2023

20.10.2023 1266

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 acalabrutinib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

20.10.2023 1271

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 for medicinal products containing ibrutinib based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

20.10.2023 1610

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 for medicinal products containing artesunate based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

20.10.2023 1836

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 nintedanib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of June 05-08, 2023

Changes to the safety information of medicinal products containing rituximab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of June 05-08, 2023

Changes to the safety information for medicinal products containing aprotinin based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

Changes to the safety information of medicinal products containing nirmatrelvir, ritonavir (nirmatrelvir, ritonavir) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

The Pharmacovigilance Risk Assessment Committee (PRAC) recommends new safety measures to avoid exposure to medicinal products containing topiramate during pregnancy

Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and grounds for amending the registration materials of medicinal products containing sildenafil (sildenafil)

Changes to the safety information of medicinal products containing aflibercept following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of July 03-06, 2023

Changes to the safety information on acalabrutinib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

Changes to the safety information for medicinal products containing ibrutinib based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

Changes to the safety information for medicinal products containing artesunate based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 03-06 July 2023

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