2026 – Page 8 – State Expert Center of the Ministry of Health of Ukraine

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять рифампіцин (rifampicin)

30.03.2026 326

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…

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять ванкоміцин (vancomycin)

30.03.2026 340

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…

Зміни інформації з безпеки лікарських засобів, що містять ванкоміцин (vancomycin) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 29 вересня – 02 жовтня 2025 року

24.03.2026 402

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…

Зміни інформації з безпеки лікарських засобів, що містять дапагліфлозин (dapagliflozin) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 29 вересня – 02 жовтня 2025 року

17.03.2026 566

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 codeine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 02 October 2025

02.03.2026 692

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 ribociclib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 2 October 2025

26.02.2026 423

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 bevacizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 2 October 2025

26.02.2026 533

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 pegylated liposomal doxorubicin, following the signal review by the PRAC at its meeting on 12-15 January 2026

26.02.2026 448

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 package insert of the vaccine for the prevention of varicella (live) [varicella vaccine (live)]

26.02.2026 535

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 testosterone [for topical use] following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 1 – 4 September 2025

25.02.2026 467

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…

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять рифампіцин (rifampicin)

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять ванкоміцин (vancomycin)

Changes to the safety information of medicinal products containing codeine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 02 October 2025

Changes to the safety information of medicinal products containing ribociclib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 2 October 2025

Changes to the safety information of medicinal products containing bevacizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 September – 2 October 2025

Update of the safety information of medicinal products containing pegylated liposomal doxorubicin, following the signal review by the PRAC at its meeting on 12-15 January 2026

Regarding amendments to the package insert of the vaccine for the prevention of varicella (live) [varicella vaccine (live)]

Changes to the safety information of medicinal products containing testosterone [for topical use] following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 1 – 4 September 2025

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"

PHARMEXPERT 2024. Standards. Innovations. European integration