2022

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2022
Changes to safety information for medicinal products containing enoxaparin (enoxaparin) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25 – October 28, 2021

The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 25 – 28 October 2021…

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Changes to safety information for medicinal products containing bimatoprost (bimatoprost) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25 – October 28, 2021

The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 25 – 28 October 2021…

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Update of safety information for medicinal products containing ocrelizumab (ocrelizumab) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25 – October 28, 2021

The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 25 – 28 October 2021…

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Changes to the safety information of medicinal products containing dimethyl fumarate following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25 – 28 October 2021

The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 25 – 28 October 2021…

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

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

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Report on the meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) held on 19-20 July 2022

Nonsteroidal anti-inflammatory drugs (NSAIDs) for systemic use and their use during pregnancy. In July 2022, PRAC gave recommendations…

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

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

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

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

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Regarding amendments to the package leaflets of medicinal products containing methylphenidate (methylphenidate)

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

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Highlights of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 4-7 July 2022

Medicinal products containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize the risk of meningioma PRAC recommended…

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