2022 – Page 13 – State Expert Center of the Ministry of Health of Ukraine

Start of the review concerning studies conducted at Synchron Research Services, India

21.02.2022 1270

The European Medicines Agency (EMA) has started a review of medicinal products studied by Synchron Research Services, a contract research organization (CRO) located in…

Updated safety information on COVID-19 vaccines

21.02.2022 1885

On 17 February 2022, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) published an update of safety information…

Hydroxychloroquine: increased risk of cardiovascular complications when used with macrolide antibiotics; reminder about psychiatric reactions

21.02.2022 3140

Before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients receiving hydroxychloroquine, carefully weigh the benefit and…

Regarding amendments to the package leaflet of the COVID-19 mRNA vaccine (nucleoside-modified) (Spikevax)

21.02.2022 1509

Taking into account the report of the Pharmacovigilance Risk Assessment Committee (PRAC) based on the assessment of the analysis of Periodic Safety Update Reports (PSURs)…

Regarding amendments to the instructions for medical use of medicinal products containing nadroparin (nadroparin)

21.02.2022 1701

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

Updated safety information on COVID-19 vaccines

17.02.2022 1225

On 20 January 2022, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) published an update of safety information…

Regarding amendments to the package insert for medicinal products containing quinapril/hydrochlorothiazide (quinapril/ hydrochlorothiazide)

15.02.2022 1629

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 quinapril (quinapril)

15.02.2022 1477

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 pregabalin (pregabalin)

15.02.2022 4058

Having considered the available data from preclinical and clinical studies, EudraVigilance, and the literature, and also taking into account the pathophysiological mechanism and clinical characteristics of toxic epidermal necrolysis…

Щодо внесення змін до інструкції для медичного застосування лікарського засобу, що містить дурвалумаб (durvalumab)

15.02.2022 1473

Based on a review of the available data from EudraVigilance and the literature, the Pharmacovigilance Risk Assessment Committee (PRAC) considers that the degree…

Start of the review concerning studies conducted at Synchron Research Services, India

Updated safety information on COVID-19 vaccines

Hydroxychloroquine: increased risk of cardiovascular complications when used with macrolide antibiotics; reminder about psychiatric reactions

Regarding amendments to the package leaflet of the COVID-19 mRNA vaccine (nucleoside-modified) (Spikevax)

Regarding amendments to the instructions for medical use of medicinal products containing nadroparin (nadroparin)

Updated safety information on COVID-19 vaccines

Regarding amendments to the package insert for medicinal products containing quinapril/hydrochlorothiazide (quinapril/ hydrochlorothiazide)

Regarding amendments to the instructions for medical use of medicinal products containing quinapril (quinapril)

Regarding amendments to the instructions for medical use of medicinal products containing pregabalin (pregabalin)

Щодо внесення змін до інструкції для медичного застосування лікарського засобу, що містить дурвалумаб (durvalumab)

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