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

Зміни інформації з безпеки лікарських засобів, що містять ібрутиніб (ibrutinib) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 06 – 09 липня 2026 року

21.10.2026 126

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 левофлоксацин для внутрішньовенного та перорального застосування [levofloxacin (intravenous and oral use)] за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 08 – 11 червня 2026 року

15.10.2026 270

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 06 – 09 July 2026

12.10.2026 167

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 enfortumab vedotin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on 06 – 09 July 2026

12.10.2026 181

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…

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

05.10.2026 412

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…

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

30.09.2026 228

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 laronidase following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

21.09.2026 200

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 methotrexate

21.09.2026 250

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 ranibizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

11.09.2026 234

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 acalabrutinib (acalabrutinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

11.09.2026 226

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 06 – 09 July 2026

Changes to the safety information for medicinal products containing enfortumab vedotin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on 06 – 09 July 2026

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 phenylephrine / tropicamide (phenylephrine / tropicamide)

Changes to the safety information of medicinal products containing laronidase following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

Regarding amendments to the instructions for medical use of medicinal products containing methotrexate

Changes to the safety information of medicinal products containing ranibizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

Changes to the safety information of medicinal products containing acalabrutinib (acalabrutinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

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