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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...
www.ema.europa.eu EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.Patients’ perspectives...
www.ema.europa.eu EMA’s Patients and Consumer Working Party (PCWP) has elected Marco Greco of the European Patients Forum as its new co-chair. The Healthcare Professionals’ Working Party (HCPWP)…, Marco Greco is a lawyer by training and has extensive advocacy experience. He is a...