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...

www.ema.europa.eu EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove...

www.ema.europa.eu Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Akeega (niraparib/abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2...