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...
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EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign – www.ema.europa.eu
www.ema.europa.eu The campaign was developed jointly with the European Consumer Organisation, the European Association of Hospital Pharmacists, European Association of Nuclear Medicine, the European Paediatric Neurology Society , the European Community Pharmacists and the European Union of...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025 – www.ema.europa.eu
www.ema.europa.eu New safety information for healthcare professionals Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally PRAC agreed on a direct healthcare professional communication (DHPC) to remind healthcare professionals that extreme caution...
ICMRA Summit 2025: EMA concludes its two mandates as chair – www.ema.europa.eu
www.ema.europa.eu At the ICMRA Summit 2025, international medicines authorities addressed the regulators’ role as communicators of reliable, evidence-based, scientific information and the importance of trust and transparency. They highlighted positive examples of reliance pathways saving...
EMA partners with content creators to promote safe and responsible use of GLP-1 medicines – www.ema.europa.eu
www.ema.europa.eu Partnering with content creators The Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical coverage. They were chosen for their credibility in healthcare communication and their alignment...
First treatment for serious chronic lung disease – www.ema.europa.eu
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...