www.ema.europa.eu International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition based on the emerging evidence on coronavirus SARS-CoV-2 variants and lessons learned from...

www.ema.europa.eu The European Medicines Agency's (EMA) office is closed on Monday 29 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 this is an emergency number and should only be used in...

www.ema.europa.eu Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting.The committee recommended granting a marketing authorisation for Pylclari (piflufolastat (18F)), intended for the diagnosis of...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease.This follows a...

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 Eluracat (capromorelin tartrate), from Elanco GmbH, a new product for body weight gain in cats...

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 Eluracat (capromorelin tartrate), from Elanco GmbH, a new product for body weight gain in cats...