EMA – Page 10 – State Expert Center of the Ministry of Health of Ukraine

Update on nitrosamines in medicinal products registered in the European Union

04.03.2020 3443

The European Union and national control authorities continue their work to prevent the presence of nitrosamine impurities in medicinal products registered in…

SIGNAL Ginkgo biloba L. and cardiac arrhythmia (according to the WHO global database VigiBase)

27.02.2020 4509

Ginkgo (Ginkgo biloba L; Ginkgoaceae) is a dioecious plant that has been used in medicine for about 5000 years. Today standardized concentrated extracts and…

SIGNAL Clozapine and the absence of dose titration practice (according to the WHO global database VigiBase)

26.02.2020 3140

During monitoring of the WHO global database VigiBase, which receives reports on the safety of medicinal products, a series of cases was identified that…

Restrictions on the use of medicinal products containing cyproterone due to the risk of meningioma

18.02.2020 3148

The PRAC committee recommended using medicinal products containing cyproterone: with a daily dose of cyproterone 10 mg or more for androgen-dependent conditions,…

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

18.02.2020 2405

Dear applicants! The Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of the analysis of Periodic Safety Update Reports (PSURs) for…

On amendments to the package leaflet of a medicinal product containing Abiraterone – interaction with sulfonylureas leading to hypoglycemia

11.02.2020 2330

Dear applicants! Having reviewed the available evidence from EudraVigilance, data from the literature, and the cumulative review submitted by the registration certificate holder for the medicinal product Zytiga…

Regarding amendments to the package insert for the medicinal product containing Golimumab – inflammatory myopathy

11.02.2020 2151

Dear applicants! Having considered the available evidence from EudraVigilance, literature data, and the cumulative review submitted by Janssen Biologics B.V, the PRAC committee…

Measures to minimize the risk of serious adverse reactions after the use of Lemtrada (alemtuzumab)

07.02.2020 3070

On 14 November 2019, the EMA recommended restricting the use of the medicinal product Lemtrada (alemtuzumab), which is used in multiple sclerosis. The restrictions were applied…

Signal Agomelatine and increased blood pressure (according to the WHO global database VigiBase)

06.02.2020 2619

SIGNAL Agomelatine and increased blood pressure (according to the WHO global database VigiBase) Agomelatine is a non-selective melatonin receptor antagonist MT1…

Official website of the European Medicines Agency – PRAC decisions and divergent positions on the decisions of the PRAC and CHMP committees regarding the medicinal product Lemtrada (alemtuzumab), used for the treatment of multiple sclerosis

31.01.2020 2608

During the assessment of the periodic safety update report for the medicinal product lemtrada, the following new serious safety concerns were identified, which were identified…

Update on nitrosamines in medicinal products registered in the European Union

SIGNAL Ginkgo biloba L. and cardiac arrhythmia (according to the WHO global database VigiBase)

SIGNAL Clozapine and the absence of dose titration practice (according to the WHO global database VigiBase)

Restrictions on the use of medicinal products containing cyproterone due to the risk of meningioma

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

On amendments to the package leaflet of a medicinal product containing Abiraterone – interaction with sulfonylureas leading to hypoglycemia

Regarding amendments to the package insert for the medicinal product containing Golimumab – inflammatory myopathy

Measures to minimize the risk of serious adverse reactions after the use of Lemtrada (alemtuzumab)

Signal Agomelatine and increased blood pressure (according to the WHO global database VigiBase)

Official website of the European Medicines Agency – PRAC decisions and divergent positions on the decisions of the PRAC and CHMP committees regarding the medicinal product Lemtrada (alemtuzumab), used for the treatment of multiple sclerosis

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