www.ema.europa.eu On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about what this means for...
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EMA business hours on Europe Day, Tuesday 9 May – www.ema.europa.eu
www.ema.europa.eu The European Medicines Agency's (EMA) office is closed from 18:30 on Monday 8 May until 07:30 on Wednesday 10 May 2023.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...
Review of transparency rules for the EU Clinical Trials Information System (CTIS) – www.ema.europa.eu
www.ema.europa.eu EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an...
First vaccine to protect older adults from respiratory syncytial virus (RSV) infection – www.ema.europa.eu
www.ema.europa.eu EMA has recommended a marketing authorisation in the European Union (EU) for Arexvy (recombinant, adjuvanted), the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 – 26 April 2023 – www.ema.europa.eu
www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its April 2023 meeting.The CHMP recommended granting a marketing authorisation for Arexvy (recombinant, adjuvanted), the first vaccine for active...
EMA business hours over King’s Day and Labour Day, 27 April and 1 May – www.ema.europa.eu
www.ema.europa.eu The European Medicines Agency's (EMA) office is closed for King's Day on Thursday 27 April and for Labour Day on Monday 1 May 2023.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...