2022 – Page 14 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the package inserts for medicinal products containing promestriene [cream and vaginal capsules]

07.02.2022 2439

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

Assessment of signals regarding the development of myocarditis and pericarditis after use of the Comirnaty and Spikevax vaccines

07.02.2022 1363

Signal assessment reports on the development of myocarditis and pericarditis after the use of Tozinameran (COVID-19 mRNA… have been published on the website of the European Medicines Agency.

Regarding amendments to the package inserts of medicinal products containing latanoprost (latanoprost) [except medicinal products with indications for pediatric use]

02.02.2022 1546

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 instructions for medical use of medicinal products containing fentanyl (fentanyl)

28.01.2022 3497

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 instructions for medical use of medicinal products containing isotretinoin (isotretinoin)

27.01.2022 1813

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 package leaflet (instructions for medical use) of medicinal products containing hydroxychloroquine

27.01.2022 2103

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 instructions for medical use of medicinal products containing oxycodone (oxycodone)

27.01.2022 1269

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 instructions for medical use of medicinal products containing dobutamine (dobutamine)

21.01.2022 1725

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 package leaflet (instructions for medical use) of medicinal products containing ofloxacin (systemic use)

21.01.2022 2061

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 package insert for medicinal products containing olmesartan, including fixed-dose combinations

20.01.2022 1616

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

Regarding amendments to the package inserts for medicinal products containing promestriene [cream and vaginal capsules]

Assessment of signals regarding the development of myocarditis and pericarditis after use of the Comirnaty and Spikevax vaccines

Regarding amendments to the package inserts of medicinal products containing latanoprost (latanoprost) [except medicinal products with indications for pediatric use]

On amending the instructions for medical use of medicinal products containing fentanyl (fentanyl)

On amending the instructions for medical use of medicinal products containing isotretinoin (isotretinoin)

Regarding amendments to the package leaflet (instructions for medical use) of medicinal products containing hydroxychloroquine

On amending the instructions for medical use of medicinal products containing oxycodone (oxycodone)

On amending the instructions for medical use of medicinal products containing dobutamine (dobutamine)

Regarding amendments to the package leaflet (instructions for medical use) of medicinal products containing ofloxacin (systemic use)

Regarding amendments to the package insert for medicinal products containing olmesartan, including fixed-dose combinations

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