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...

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 EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This...

www.ema.europa.eu EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).Evidence from more than 13 billion doses of COVID-19 vaccines administered worldwide shows that these vaccines aimed...

www.ema.europa.eu Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent...