www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth...

www.ema.europa.eu EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines, such as medicines with the potential to address antimicrobial resistance (AMR), respiratory syncytial virus (RSV) infections or newly diagnosed...

www.ema.europa.eu EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation,...

www.ema.europa.eu The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EU) 2019/6, the Committee adopted, by consensus, a positive opinion for a marketing authorisation for Yurvac RHD, from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of rabbits from 30...

www.ema.europa.eu EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These medicines are used for...