www.ema.europa.eu EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines.The review is focussing on data from a retrospective observational study...

www.ema.europa.eu The European Medicines Agency announces with deep sadness the death of Noël Wathion, its former Deputy Executive Director, on 12 August 2023. Our most profound sympathies and condolences go to Noël’s family and friends. He was 66 and leaves behind his wife, son,...

www.ema.europa.eu The European Medicines Agency's (EMA) office is closed on Tuesday 15 August 2023.Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number that should only be used...

www.ema.europa.eu On 26 May 2023, EMA’s human medicines committee (CHMP) recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease.This...

www.ema.europa.eu EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies. The actions presented in the report aim...

www.ema.europa.eu 14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant), a vaccine to protect small infants...