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www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Brinsupri (brensocatib) 25 mg tablets, for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older who have had two or more exacerbations...
www.ema.europa.eu Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its October 2025 meeting. The committee recommended granting a marketing authorisation for Brinsupri (brensocatib), the first treatment for...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation from Zoetis Belgium for Lenivia (izenivetmab), for the reduction of pain associated with osteoarthritis in dogs. The Committee adopted a...
www.ema.europa.eu EMA mid-year report 2025 EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan and non-orphan) remain at the same high level as last year (29 vs 30 applications in Q1-Q2 2024)....
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 is advising marketing authorisation holders to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23...