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www.ema.europa.eu EMA's office is closed from 18:00 on Monday 22 December 2025 to 08:30 on Monday 5 January 2026. Outside of working hours and on public holidays, it is possible to call our product emergency hotline on +31(0)88 781 7600. Please note that this is an emergency number and...
www.ema.europa.eu Seven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting. The committee recommended granting a conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept),...
www.ema.europa.eu EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and...
www.ema.europa.eu The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and procedures which have been introduced by different pieces of legislation over the years, namely the existing...
www.ema.europa.eu Sales data of antimicrobials for food-producing animals In 2024, 98% of total sales of antimicrobial VMPs were for food-producing animals. Sales for this group increased by 5% compared to 2023. These results suggest that the overall declining trend observed between 2010...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation from Elanco GmbH for Varenzin (molidustat), for the management of non-regenerative anaemia associated with chronic kidney disease (CKD) in cats, by...