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www.ema.europa.eu The main role of the CAT is to evaluate applications for ATMPs submitted to EMA and draft an opinion, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine. CAT is also responsible for...
www.ema.europa.eu The HMPC is the committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market. HMPC prepares EMA’s opinions on herbal substances and preparations, along with...
www.ema.europa.eu EMA has published an overview of its key recommendations of 2025 regarding the authorisation and safety monitoring of veterinary medicines. In 2025, EMA recommended 30 veterinary medicines for marketing authorisation - the highest number of recommendations ever in a year...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion on a marketing authorisation from Elanco for Lotilaner / Milbemycin Elanco (lotilaner / milbemycin oxime), for use in dogs with, or at risk from, mixed infestations/infections by ticks,...
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 In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such...