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www.ema.europa.eu EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizoleProduct information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosisEMA’s safety committee (PRAC) has...
www.ema.europa.eu EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work.LLMs are a category of generative AI, whose...
www.ema.europa.eu Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number that should… Vai all'articolo completo.
www.ema.europa.eu EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies...
www.ema.europa.eu EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation of medicines in Africa.AUDA-NEPAD has been working on...
www.ema.europa.eu 10 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of...