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www.ema.europa.eu EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects.The previous temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review,...
www.ema.europa.eu EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.These medicines are currently the...
www.ema.europa.eu EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and to support long‑term abstinence.The review was triggered by the assessment of a marketing...
www.ema.europa.eu 13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its June 2025 meeting.The committee recommended granting a marketing authorisation for Austedo (deutetrabenazine), for the treatment of adults with...
www.ema.europa.eu EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Rezdiffra (resmeritom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, in...
www.ema.europa.eu In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public...