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...

www.ema.europa.eu EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects.The previous temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review,...