Webb1 apr. 2024 · In January 2024, the Commission on Human Medicine (CHM) published a review of the available safety data for antiepileptics during pregnancy. Their report concluded that data show that carbamazepine, phenobarbital, phenytoin, and topiramate are associated with an increased risk of major congenital malformations although data … WebbEMA’s human medicines committee ( CHMP) recommended nine medicines for approval at its September 2024 meeting. The Committee adopted a positive opinion for Artesunate …
Requesting scientific advice or protocol assistance from EMA
Webb1 juni 2024 · FOI 22/503. 8th March 2024. Dear. FOI 22/503 - Freedom of Information Request: CHM meeting minutes. Thank you for your correspondence of 28th February … Webb21 apr. 2024 · The MHRA will operate a ‘fixed submission date’ system to facilitate consultation with the Commission on Human Medicines (CHM) and will publish a set of dates to facilitate planning the submissions to coordinate with appropriate meeting dates of CHM. The submission slots will be linked to the dates of CHM meetings. infosys stuttgart office
Scientific advice procedures in the EU –an overview of the ... - EMWA
Webb29 dec. 2014 · How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees. From: Medicines and … WebbCMDH AGENDAS AND MINUTES 2024. Meeting 14-16 December 2024: Agenda - Minutes. Meeting 09-11 November 2024: Agenda - Minutes. Meeting 12-14 October 2024: Agenda - Minutes. Meeting 14-16 September 2024: Agenda - Minutes. Meeting 20-22 July 2024: Agenda - Minutes. Meeting 22-23 June 2024: Agenda - Minutes - Correction … Webb21 dec. 2024 · This page lists questions that marketing-authorisation holders (MAHs) may have on type-II variations. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication. infosys summer intern