www.ema.europa.eu The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024.The deadline for submission of...
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Call for expressions of interest for patients’ organisations representatives to join Committee for Orphan Medicinal Products (COMP) – www.ema.europa.eu
www.ema.europa.eu The European Commission has launched a call for expressions of interest to represent patients’ organisations in EMA's Committee for Orphan Medicinal Products (COMP).The call aims to fill three positions for COMP members nominated by the European Commission to represent...
EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5 – www.ema.europa.eu
www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12...
EMA business hours over All Saints’ Day and All Souls’ Day, 1 and 2 November – www.ema.europa.eu
www.ema.europa.eu The European Medicines Agency's (EMA) office is closed on Wednesday 1 November and Thursday 2 November 2023 for All Saints’ Day and All Souls’ Day.Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 – www.ema.europa.eu
www.ema.europa.eu GLP-1 receptor agonists: available evidence not supporting link with thyroid cancerEMA’s safety committee (PRAC) has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1) - exenatide,...
EMA takes further steps to address critical shortages of medicines in the EU – www.ema.europa.eu
www.ema.europa.eu Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage.The solidarity mechanism,...