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

On amending the package inserts for medicinal products containing donepezil

21.12.2022 1601

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 bupropion

20.12.2022 1267

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 dorzolamide

09.12.2022 1400

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 carboplatin

09.12.2022 1834

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 mesalazine

09.12.2022 1239

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 mesterolone

09.12.2022 1862

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

Update of the safety information of medicinal products containing elasomeran (elasomeran [COVID-19 mRNA vaccine – Spikevax]), adopted by the PRAC committee during the review of signals discussed at the meeting of 24-27 October 2022

08.12.2022 871

Having considered all available evidence, including spontaneous reports from EudraVigilance, data from national reviews, and observational studies provided by the registration certificate holder (RCH),…

Update on the safety information for medicinal products containing tozinameran (tozinameran [COVID-19 mRNA vaccine – Comirnaty]) , adopted by the PRAC committee during the review of signals discussed at the meeting of 24-27 October 2022

08.12.2022 1029

Having considered all available evidence, including spontaneous reports from EudraVigilance, data from national reviews, and observational studies provided by the registration certificate holder (RCH),…

Update of safety information on medicinal products containing durvalumab, adopted by the PRAC committee during the review of signals discussed at the meeting on 24-27 October 2022

08.12.2022 1812

Based on the available evidence, a causal relationship between the occurrence of transverse myelitis and the use of durvalumab is considered to be at least a reasonable possibility, therefore…

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

08.12.2022 1595

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

On amending the package inserts for medicinal products containing donepezil

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

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

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

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 mesterolone

Update of the safety information of medicinal products containing elasomeran (elasomeran [COVID-19 mRNA vaccine – Spikevax]), adopted by the PRAC committee during the review of signals discussed at the meeting of 24-27 October 2022

Update on the safety information for medicinal products containing tozinameran (tozinameran [COVID-19 mRNA vaccine – Comirnaty]) , adopted by the PRAC committee during the review of signals discussed at the meeting of 24-27 October 2022

Update of safety information on medicinal products containing durvalumab, adopted by the PRAC committee during the review of signals discussed at the meeting on 24-27 October 2022

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

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