www.ema.europa.eu The European Medicines Agency's (EMA) office is closed from 18:00 on Thursday 14 August 2025 to 08:30 on Monday 18 August 2025.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...

www.ema.europa.eu EMA has recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global warming potential (GWP) gas alternative. The new low GWP alternative propellant has a 1000-fold...

www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1)...

www.ema.europa.eu The main role of the PDCO is to prospectively guide sponsors or companies on how to consider a medicine’s use in children during its development. In this context, the committee assesses the content of paediatric investigation plans as well as applications for a full or...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Axience for Hemosyvet(etamsylate) for prevention and treatment of surgical, post traumatic, obstetric and gynaecological haemorrhages in...