www.ema.europa.eu This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk. The initial recommendation followed the full re-evaluation of...

www.ema.europa.eu EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.In 2023, EMA recommended 14 medicines for marketing authorisation. Of these, nine had a new active substance - a threefold increase...

www.ema.europa.eu The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development, and...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Metacam (meloxicam), from Boehringer Ingelheim Vetmedica GmbH, to modify the indication for use in cats for Metacam 5...

www.ema.europa.eu In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public...

www.ema.europa.eu EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during...