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  1. 30. Apr. 2024 · The European Medicines Agency (EMA) is providing a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the 2024-2025 vaccination campaign. The composition of vaccines against COVID-19 has changed three times since first approval in 2020.

  2. Vor 5 Tagen · 7 May 2024. Human COVID-19 Medicines. EMA closed 9-10 May. The European Medicines Agency's (EMA) office is closed from 18:00 on Wednesday 8 May 2024 to 07:30 on Monday 13 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31 (0)88 781 7600.

  3. 7. Mai 2024 · Human regulatory: overview. Public health threats. Coronavirus disease (COVID-19) COVID-19 medicines. Human COVID-19. Updated on 7 May, 2024: 'Authorised COVID-19 vaccines' section and 'COVID-19 vaccines: strains, use and age ranges' section. Also on this topic. COVID-19 vaccines: key facts. Safety of COVID-19 vaccines.

  4. 30. Apr. 2024 · The European Medicines Agency (EMA) has published a document that elaborates on the application of Real-World Data (RWD) in evaluating human medicines. This document succinctly outlines the utility of Real-World Evidence (RWE), which is derived from RWD analysis, within the scope of regulatory decision-making.

  5. Vor 4 Tagen · Dive Brief: The European Medicines Agency (EMA) has updated its advice for developers of combinations of medicinal products and medical devices. In an update posted Tuesday, the EMA answered six new questions to clarify topics such as how companies can access advice on the classification of drug-device combinations and the ...

  6. 2. Mai 2024 · The new version of the Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which addresses issues that may be relevant after authorisation has been granted, contains some additions, revisions and innovations in the following passages: Chapter 1 Type IA Variations.

  7. Vor einem Tag · Mee per E-Mail kontaktéiert gouf: "AstraZeneca huet de Réckzuch initiéiert, net d'EMA, an dëst opgrond vun engem Mangel u Commanden, well nei Impfstoffer op de Maart koumen, déi fir déi nei ...