www.ema.europa.eu EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an...

www.ema.europa.eu EMA has recommended a marketing authorisation in the European Union (EU) for Arexvy (recombinant, adjuvanted), the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial...

www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its April 2023 meeting.The CHMP recommended granting a marketing authorisation for Arexvy (recombinant, adjuvanted), the first vaccine for active...

www.ema.europa.eu The European Medicines Agency's (EMA) office is closed for King's Day on Thursday 27 April and for Labour Day on Monday 1 May 2023.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...

www.ema.europa.eu This year, European Immunization Week, marked between 23 and 29 April, reminds us about the importance of timely routine vaccination and why we need to catch up on any missed or postponed vaccines and booster doses.Several routine vaccines are available for all age groups...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EU) 2019/6The Committee adopted by consensus a positive opinion for a variation requiring assessment for Gumbohatch (live Avian infectious bursal disease vaccine) concerning the amendment of the indication by...