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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 The European Commission has launched a call for expressions of interest to represent patient and healthcare professional organisations in EMA’s Paediatric Committee (PDCO). Three members and alternates from patient organisations and three members and alternates from...
www.ema.europa.eu The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The overall goal is to ensure alignment between the regulatory approval requirements and national or ethics perspective on clinical trial...
www.ema.europa.eu Ten new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting. The committee recommended granting a marketing authorisation for Dawnzera (donidalorsen), for the routine prevention of...
www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and in children from 8 years of age with stage 2 type 1 diabetes. Type 1 diabetes is a chronic autoimmune...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Vaxxinact H5 (Avian influenza vaccine (subunit recombinant)) intended for the following indications associated with...