www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EC) No 726/2004The Committee adopted by consensus a positive opinion for a marketing authorisation of Newflend ND H9, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of one-day-old...

www.ema.europa.eu EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.“The achievements...

www.ema.europa.eu The Management Board was updated on the ongoing efforts of EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to closely monitor several critical shortages of medicines in the EU/EEA, in particular medicines containing the antibiotic...

www.ema.europa.eu At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EU) 2019/6The Committee adopted by consensus a positive opinion for a marketing authorisation application for Brucellin Aquilon (Brucella abortus), from Aquilon Cyl S.L., a new product for in vivo diagnosis of...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsThe Committee adopted, by consensus, a positive opinion for a marketing authorisation application for Prolevare, an informed consent application, from Zoetis Belgium, a new product for the treatment of pruritus associated with...