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

Regarding amendments to the package leaflets of medicinal products containing fluconazole

11.01.2021 4053

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

The European Medicines Agency confirms its recommendation to suspend the use of all medicinal products containing ranitidine in the European Union

23.12.2020 3554

On 17 September 2020, the CHMP confirmed its recommendation to suspend the use of all medicinal products containing ranitidine in the EU due to…

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

17.12.2020 2595

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

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

10.12.2020 4161

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

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

10.12.2020 2252

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

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

07.12.2020 3244

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

Update to information on psychiatric disorders regarding medicinal products containing chloroquine and hydroxychloroquine

02.12.2020 2651

highlights of the PRAC meeting of 23-26 November 2020 The PRAC committee recommends updating the instructions for medical use for medicinal products,…

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

02.12.2020 3868

Based on the assessment of periodic safety update reports for medicinal products containing clobetasol, the PRAC Committee drew the following scientific conclusions….

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2829

medicinal products containing ceftriaxone – encephalopathy Based on the available evidence from preclinical data, post-marketing studies, clinical trials, literature and…

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2428

medicinal products containing dabrafenib, trametinib – sarcoidosis Having reviewed the available evidence and analyzed the data provided by the relevant marketing authorization holder, the committee…

Regarding amendments to the package leaflets of medicinal products containing fluconazole

The European Medicines Agency confirms its recommendation to suspend the use of all medicinal products containing ranitidine in the European Union

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

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

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

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

Update to information on psychiatric disorders regarding medicinal products containing chloroquine and hydroxychloroquine

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

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

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