https://www.ema.europa.eu/en/homepageNews and press releasesen-gbCopyright: (C) European Medicines AgencyWed, 17 Jul 2024 12:33:21 +0200Fri, 12 Jul 2024 12:00:00 +0200https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024PRAC elects new chairThe July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after serving for…, Agenda Agenda of the PRAC meeting 8-11 July 2024DraftReference Number: EMA/PRAC/276333/2024 English (EN…, PRAC statistics: July 2024 , PRAC statistics: July 2024 English (EN) (33.15 MB - PDF)First published: 12/07/2024View, Glossary: Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…, Ongoing referrals ProcedureStatusUpdateMetamizole containing medicinal products - referralUnder evaluationPRAC continued its assessmenthttps://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024Fri, 12 Jul 2024 12:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0Update as of 11 July 2024:The company for Translarna has requested a re-examination of EMA’s June 2024 opinion. Upon receipt of the grounds of this request, the Agency will re-…https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0Thu, 11 Jul 2024 15:30:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/emas-safety-committee-elects-new-chairAt its July 2024 meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) elected Ulla Wändel Liminga as its new Chair for a three-year mandate starting in…, Dr Wändel Liminga has been one of the Swedish PRAC delegates since the committee was established in 2012.“As a chair, I want to build on the collective experience of PRAC and…https://www.ema.europa.eu/en/news/emas-safety-committee-elects-new-chairThu, 11 Jul 2024 12:58:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/recent-additions-emas-management-teamGeorgia Gavriilidou joined EMA on 1 July 2024 as the new Head of the Legal Department, following the retirement of Stefano Marino. She brings over 17 years of in-depth legal and…https://www.ema.europa.eu/en/news/recent-additions-emas-management-teamThu, 04 Jul 2024 12:25:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.The committee recommended granting a marketing authorisation …, Positive recommendations on new medicines , Balversa Common name erdafitinib  Marketing-authorisation applicant…, Eurneffy INN epinephrine Marketing-authorisation applicant Ars…, mResvia INN Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the…, Ordspono INN odronextamab  Marketing-authorisation applicant…, Piasky Common name crovalimab Marketing-authorisation applicant…, Tauvid INN Flortaucipir (18F) Marketing-authorisation applicant Eli…, Winrevair Common name sotatercept Marketing-authorisation applicant…, Positive recommendation on new biosimilar medicine , Steqeyma INN ustekinumab Marketing-authorisation applicant…, Positive recommendations on new generic medicines , Enzalutamide Viatris INN enzalutamide Marketing-authorisation applicant…, Nilotinib Accord INN nilotinib Marketing-authorisation applicant…, Negative recommendations on new medicines , Masitinib AB Science INN masitinib Marketing-authorisation applicant…, Syfovre INN pegcetacoplan Marketing-authorisation applicant Apellis…, Non-renewal of conditional marketing authorisation , Translarna INN ataluren  Marketing authorisation applicant PTC…, Positive recommendations on extensions of indications , Betmiga INN mirabegron Marketing-authorisation holder Astellas…, Beyfortus INN nirsevimab Marketing-authorisation holder Sanofi…, Cresemba INN isavuconazole Marketing-authorisation holder Basilea…, Imcivree INN setmelanotide Marketing-authorisation holder Rhythm…, Imfinzi INN durvalumab Marketing-authorisation holder AstraZeneca…, Infanrix hexa INN diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inact.) and…, Lynparza INN olaparib Marketing-authorisation holder AstraZeneca…, Pegasys INN peginterferon alfa-2a Marketing-authorisation holder…, Tepkinly INN epcoritamab Marketing-authorisation holder AbbVie…, Vabysmo INN faricimab Marketing-authorisation holder Roche…, Xalkori INN crizotinib Marketing-authorisation holder Pfizer Europe…, Withdrawal of initial marketing authorisation application , Dabigatran etexilate Teva INN dabigatran etexilate  Marketing-authorisation holder…, Outcome of referrals , Havrix INN Hepatitis A virus (inactivated, adsorbed) Marketing-authorisation holder…, Lorazepam Macure INN lorazepam Marketing-authorisation holder…, Ocaliva INN obeticholic acid Marketing-authorisation holder Advanz…https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024Fri, 28 Jun 2024 12:01:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertensionEMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (…https://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertensionFri, 28 Jun 2024 12:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonistsEMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle…, “We need to step up actions now - industry, regulators, healthcare professionals, patients and the public at large all have a role to play in resolving these shortages and we…, Member States should consider, jointly with marketing authorisation holders, measures to control and optimise the distribution of these medicines. Member States’ continuous…, “Bringing everyone to the table is the most effective way to solve these complex shortages.” Professor Karl Broich, President of the Federal Institute for Drugs and…, The MSSG is also appealing to healthcare professionals and members of the public to follow some key recommendations.Information for healthcare professionalsThe GLP-1 receptor…https://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonistsWed, 26 Jun 2024 15:29:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-19-june-2024The Committee adopted by consensus a positive opinion for a marketing authorisation for DIVENCE IBR Marker Live from Laboratorios Hipra, S.A., a new vaccine intended for the…https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-19-june-2024Fri, 21 Jun 2024 14:37:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europeThe launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European…https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europeTue, 18 Jun 2024 11:12:00 +0200News and press releases