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...

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...

www.ema.europa.eu 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 and should only be used in the event of a potentially serious problem with a centrally authorised...