2023 – Page 10 – State Expert Center of the Ministry of Health of Ukraine

2023

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

13.01.2023 1260

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

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on 11-13 October 2022, recommendations were issued for medicinal products containing metronidazole (excluding topical use on the skin)

06.01.2023 2135

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on 11-13 October 2022, recommendations were given for medicinal products containing iopromide

06.01.2023 935

Information on the preliminary analysis of Periodic Safety Update Reports (PSURs) is posted on the Center's website https://www.dec.gov.ua/materials/shhodo-vnesennya-zmin-do-instrukcziyi-dlya-medychnogo-zastosuvannya-likarskyh-zasobiv-shho-mistyat-jopromid-iopromide/ All registration certificate holders (RCHs)…

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on October 11-13, 2022, recommendations were issued for medicinal products containing iohexol

06.01.2023 1046

Information on the preliminary analysis of Periodic Safety Update Reports (PSURs) is posted on the Center's website https://www.dec.gov.ua/materials/shhodo-vnesennya-zmin-do-instrukcziyi-dlya-medychnogo-zastosuvannya-likarskyh-zasobiv-shho-mistyat-jogeksol-iohexol/. All registration certificate holders (RCHs)…

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

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on 11-13 October 2022, recommendations were issued for medicinal products containing metronidazole (excluding topical use on the skin)

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on 11-13 October 2022, recommendations were given for medicinal products containing iopromide

By the decision of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on October 11-13, 2022, recommendations were issued for medicinal products containing iohexol

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