www.ema.europa.eu EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages...
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EMA business hours over Ascension Day holidays, 18 and 19 May – www.ema.europa.eu
www.ema.europa.eu The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 17 May until 07:30 on Monday 22 May. 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...
EMA annual report 2022 published – www.ema.europa.eu
www.ema.europa.eu EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).The digital report outlines the most important highlights regarding the evaluation and...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12 May 2023 – www.ema.europa.eu
www.ema.europa.eu Review of hydroxyprogesterone startedEMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the EU, these medicines are available as hydroxyprogesterone caproate and are given as...
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects – www.ema.europa.eu
www.ema.europa.eu EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects.These restrictions...
EMA and European medicines regulatory network lift COVID-19 business continuity status – www.ema.europa.eu
www.ema.europa.eu EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully handling the unprecedented operational challenges posed by the pandemic. This was foreseen in EMA’s workplan for 2023-2025 .‘Throughout...