https://www.ema.europa.eu/en/homepageWhat's newen-gbCopyright: (C) European Medicines AgencyTue, 14 May 2024 17:27:56 +0200Tue, 14 May 2024 17:15:00 +0200https://www.ema.europa.eu/system/files/documents/procurement/guidebook-tenderers-_2_en.pdfGuidebook for tenderershttps://www.ema.europa.eu/system/files/documents/procurement/guidebook-tenderers-_2_en.pdfTue, 14 May 2024 17:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/article-57-product-data_en_3.xlsxArticle 57 product datahttps://www.ema.europa.eu/system/files/documents/other/article-57-product-data_en_3.xlsxTue, 14 May 2024 16:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomedHuman medicines European public assessment report (EPAR): Thalidomide Lipomed, thalidomide, Date of authorisation: 19/09/2022, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomedTue, 14 May 2024 16:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mayzentHuman medicines European public assessment report (EPAR): Mayzent, siponimod, Date of authorisation: 13/01/2020, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mayzentTue, 14 May 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportClinical Trials Information System: training and supporthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportTue, 14 May 2024 14:55:00 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-july-2024Clinical Trials Information System (CTIS): Walk-in clinic - July 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 July 2024, 16:00 (CEST) to 10 July 2024, 17:00 (CEST)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-july-2024Tue, 14 May 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-mylanHuman medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Date of authorisation: 06/10/2008, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-mylanTue, 14 May 2024 14:37:00 +0200What's newhttps://www.ema.europa.eu/en/events/information-qa-session-updated-caps-web-based-eafInformation and Q&A session on updated CAPs in web-based eAF, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 May 2024, 10:00 (CEST) to 7 May 2024, 11:00 (CEST)https://www.ema.europa.eu/en/events/information-qa-session-updated-caps-web-based-eafTue, 14 May 2024 14:34:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-04-07-march-2024_en.pdfMinutes of the PRAC meeting 4-7 March 2024https://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-04-07-march-2024_en.pdfTue, 14 May 2024 14:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vegzelmaHuman medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vegzelmaTue, 14 May 2024 14:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/poteligeoHuman medicines European public assessment report (EPAR): Poteligeo, mogamulizumab, Date of authorisation: 22/11/2018, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/poteligeoTue, 14 May 2024 13:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/eu-iso-idmp-ig_chapter-1_registration-requirements_may-2024-release_en.pdfProducts Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/eu-iso-idmp-ig_chapter-1_registration-requirements_may-2024-release_en.pdfTue, 14 May 2024 12:11:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliHuman medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliTue, 14 May 2024 11:40:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/boarding-users-spor-data-services_may-2024-release_en.pdfOn-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data serviceshttps://www.ema.europa.eu/system/files/documents/other/boarding-users-spor-data-services_may-2024-release_en.pdfTue, 14 May 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/eu-iso-idmp-ig_chapter_update_en.pdfProducts Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guidehttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/eu-iso-idmp-ig_chapter_update_en.pdfTue, 14 May 2024 09:48:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsEMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)https://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsTue, 14 May 2024 09:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/flixabiHuman medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/flixabiMon, 13 May 2024 16:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/gonal-fHuman medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Date of authorisation: 20/10/1995, Revision: 26, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/gonal-fMon, 13 May 2024 16:54:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-prac-agenda-13-16-may-2024-publication_en.pdfAgenda of the PRAC meeting 13-16 May 2024https://www.ema.europa.eu/system/files/documents/agenda/draft-prac-agenda-13-16-may-2024-publication_en.pdfMon, 13 May 2024 16:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/agamreeHuman medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/agamreeMon, 13 May 2024 16:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ryzneutaHuman medicines European public assessment report (EPAR): Ryzneuta, efbemalenograstim alfa, Date of authorisation: 21/03/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ryzneutaMon, 13 May 2024 16:30:30 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/axuminHuman medicines European public assessment report (EPAR): Axumin, fluciclovine (18F), Date of authorisation: 21/05/2017, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/axuminMon, 13 May 2024 16:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bexseroHuman medicines European public assessment report (EPAR): Bexsero, meningococcal group B Vaccine (rDNA, component, adsorbed), Date of authorisation: 13/01/2013, Revision: 34, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bexseroMon, 13 May 2024 16:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ghryvelin-previously-macimorelin-aeterna-zentarisHuman medicines European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris), macimorelin, Date of authorisation: 11/01/2019, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ghryvelin-previously-macimorelin-aeterna-zentarisMon, 13 May 2024 16:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/scenesseHuman medicines European public assessment report (EPAR): Scenesse, afamelanotide, Date of authorisation: 22/12/2014, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/scenesseMon, 13 May 2024 16:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/anagrelide-viatris-previously-anagrelide-mylanHuman medicines European public assessment report (EPAR): Anagrelide Viatris (previously Anagrelide Mylan), anagrelide, Date of authorisation: 15/02/2018, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/anagrelide-viatris-previously-anagrelide-mylanMon, 13 May 2024 16:04:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/myozymeHuman medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Date of authorisation: 28/03/2006, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/myozymeMon, 13 May 2024 16:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zepatierHuman medicines European public assessment report (EPAR): Zepatier, elbasvir,grazoprevir, Date of authorisation: 22/07/2016, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zepatierMon, 13 May 2024 15:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fabrazymeHuman medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Date of authorisation: 03/08/2001, Revision: 36, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/fabrazymeMon, 13 May 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kaulivHuman medicines European public assessment report (EPAR): Kauliv, teriparatide, Date of authorisation: 12/01/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kaulivMon, 13 May 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/onglyzaHuman medicines European public assessment report (EPAR): Onglyza, saxagliptin, Date of authorisation: 30/09/2009, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/onglyzaMon, 13 May 2024 15:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-accordHuman medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod, Date of authorisation: 25/06/2020, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-accordMon, 13 May 2024 15:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rasagiline-mylanHuman medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline, Date of authorisation: 04/04/2016, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rasagiline-mylanMon, 13 May 2024 15:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/plerixafor-accordHuman medicines European public assessment report (EPAR): Plerixafor Accord, plerixafor, Date of authorisation: 16/12/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/plerixafor-accordMon, 13 May 2024 14:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-mylanHuman medicines European public assessment report (EPAR): Pregabalin Mylan, pregabalin, Date of authorisation: 24/06/2015, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-mylanMon, 13 May 2024 14:29:29 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/atrianceHuman medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 28, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/atrianceMon, 13 May 2024 14:22:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/spinrazaHuman medicines European public assessment report (EPAR): Spinraza, nusinersen, Date of authorisation: 30/05/2017, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/spinrazaMon, 13 May 2024 14:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-mylanHuman medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, Date of authorisation: 03/01/2017, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-mylanMon, 13 May 2024 14:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/granupas-previously-para-aminosalicylic-acid-lucaneHuman medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), para-aminosalicylic acid, Date of authorisation: 07/04/2014, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/granupas-previously-para-aminosalicylic-acid-lucaneMon, 13 May 2024 14:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vyndaqelHuman medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Date of authorisation: 16/11/2011, Revision: 28, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vyndaqelMon, 13 May 2024 14:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dupixentHuman medicines European public assessment report (EPAR): Dupixent, dupilumab, Date of authorisation: 26/09/2017, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dupixentMon, 13 May 2024 13:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/telmisartan-actavisHuman medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Date of authorisation: 29/09/2010, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/telmisartan-actavisMon, 13 May 2024 12:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/luxturnaHuman medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Date of authorisation: 22/11/2018, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/luxturnaMon, 13 May 2024 12:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/leqvioHuman medicines European public assessment report (EPAR): Leqvio, inclisiran, Date of authorisation: 09/12/2020, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/leqvioMon, 13 May 2024 12:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-bHuman medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Date of authorisation: 18/02/2021, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-bMon, 13 May 2024 12:04:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/orkambiHuman medicines European public assessment report (EPAR): Orkambi, lumacaftor,ivacaftor, Date of authorisation: 19/11/2015, Revision: 34, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/orkambiMon, 13 May 2024 11:41:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/reblozylHuman medicines European public assessment report (EPAR): Reblozyl, luspatercept, Date of authorisation: 25/06/2020, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/reblozylMon, 13 May 2024 11:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abrysvoHuman medicines European public assessment report (EPAR): Abrysvo, Respiratory syncytial virus vaccine (bivalent, recombinant), Date of authorisation: 23/08/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abrysvoMon, 13 May 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudaHuman medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 57, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudaMon, 13 May 2024 10:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tresibaHuman medicines European public assessment report (EPAR): Tresiba, insulin degludec, Date of authorisation: 20/01/2013, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tresibaMon, 13 May 2024 10:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/isentressHuman medicines European public assessment report (EPAR): Isentress, raltegravir, Date of authorisation: 19/12/2007, Revision: 43, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/isentressMon, 13 May 2024 10:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ryzodegHuman medicines European public assessment report (EPAR): Ryzodeg, insulin degludec,insulin aspart, Date of authorisation: 21/01/2013, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ryzodegMon, 13 May 2024 10:20:00 +0200What's newhttps://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/veterinary-limited-markets/cvmp-recommendations-limited-market-classification-eligibility-authorisation-under-article-23CVMP recommendations on limited market classification and eligibility for authorisation under Article 23https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/veterinary-limited-markets/cvmp-recommendations-limited-market-classification-eligibility-authorisation-under-article-23Wed, 08 May 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-safety-study-pass-protocols-final-results-en.xlsxTimetable: Post-authorisation safety study (PASS) protocols and final resultshttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-safety-study-pass-protocols-final-results-en.xlsxWed, 08 May 2024 15:29:29 +0200What's newhttps://www.ema.europa.eu/en/about-us/about-website/website-outages-upgradesWebsite outages and upgradeshttps://www.ema.europa.eu/en/about-us/about-website/website-outages-upgradesWed, 08 May 2024 12:13:13 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-atmp_en_0.xlsxTimetable: Initial (Full) marketing authorisation application - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-atmp_en_0.xlsxWed, 08 May 2024 10:22:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/advisory-functions-chart_source_masterorgchart_a3_en.pdfOrganisation chart: Advisory functionshttps://www.ema.europa.eu/system/files/documents/other/advisory-functions-chart_source_masterorgchart_a3_en.pdfTue, 07 May 2024 16:39:00 +0200What's newhttps://www.ema.europa.eu/en/need-maximum-residue-limit-mrl-evaluation-biological-substances-scientific-guidelineNeed for maximum residue limit (MRL) evaluation for biological substances - Scientific guidelinehttps://www.ema.europa.eu/en/need-maximum-residue-limit-mrl-evaluation-biological-substances-scientific-guidelineTue, 07 May 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazenecaHuman medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 Vaccine (ChAdOx1-S [recombinant]), Date of authorisation: 29/01/2021, Revision: 32, Status: Withdrawnhttps://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazenecaTue, 07 May 2024 15:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/hippocastani-cortexHerbal medicinal product: Hippocastani cortexArray, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/hippocastani-cortexTue, 07 May 2024 14:51:59 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Tue, 07 May 2024 14:17:00 +0200What's newhttps://www.ema.europa.eu/en/news/ema-closed-9-10-mayEMA closed 9-10 Mayhttps://www.ema.europa.eu/en/news/ema-closed-9-10-mayTue, 07 May 2024 14:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/information-session-call-proposals-eu-4-ama-leveraging-european-expertise-medicines-regulation-africaInformation session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa", Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2024, 10:00 (CEST) to 22 May 2024, 11:00 (CEST)https://www.ema.europa.eu/en/events/information-session-call-proposals-eu-4-ama-leveraging-european-expertise-medicines-regulation-africaTue, 07 May 2024 13:37:40 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicinesPRIME: priority medicineshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicinesTue, 07 May 2024 13:27:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-april-2024_en.xlsxList of medicines currently in PRIME schemehttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-april-2024_en.xlsxTue, 07 May 2024 13:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/emblaveoHuman medicines European public assessment report (EPAR): Emblaveo, aztreonam,avibactam, Date of authorisation: 22/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/emblaveoTue, 07 May 2024 12:43:00 +0200What's newhttps://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agenciesOne Health: a joint framework for action published by five EU agencieshttps://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agenciesTue, 07 May 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/product-management-service-pms-info-dayProduct Management Service (PMS) Info-Day, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024, 09:15 (CEST) to 16 April 2024, 17:30 (CEST)https://www.ema.europa.eu/en/events/product-management-service-pms-info-dayTue, 07 May 2024 11:50:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-factsCOVID-19 vaccines: key factshttps://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-factsTue, 07 May 2024 11:39:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-035-ropa-access-control-system-public-en.pdfRecord of data processing activity relating to Security Access Control System (public)https://www.ema.europa.eu/system/files/documents/other/ema-035-ropa-access-control-system-public-en.pdfMon, 06 May 2024 16:57:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-065-ropa-audiovisual_cameras-public-en.pdfRecords of data processing activity (public) for audiovisual tool for checking presence in meeting roomshttps://www.ema.europa.eu/system/files/documents/other/ema-065-ropa-audiovisual_cameras-public-en.pdfMon, 06 May 2024 16:54:16 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-035-dpn-access-control-system-public-en.pdfEuropean Medicines Agency’s privacy statement for the operation of the Security Access Control Systemhttps://www.ema.europa.eu/system/files/documents/other/ema-035-dpn-access-control-system-public-en.pdfMon, 06 May 2024 16:51:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-065-dpn-audiovisual_cameras-public-en.pdfEuropean Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting roomshttps://www.ema.europa.eu/system/files/documents/other/ema-065-dpn-audiovisual_cameras-public-en.pdfMon, 06 May 2024 16:47:54 +0200What's newhttps://www.ema.europa.eu/en/about-us/procurementProcurementhttps://www.ema.europa.eu/en/about-us/procurementMon, 06 May 2024 16:38:54 +0200What's newhttps://www.ema.europa.eu/en/events/ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaEMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma, Online, European Medicines Agency, Amsterdam, the Netherlands, 12 January 2024https://www.ema.europa.eu/en/events/ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaMon, 06 May 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/report/meeting-report-joint-ema-eortc-workshop-soft-tissue-bone-sarcoma-workshop_en.pdfMeeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma Workshophttps://www.ema.europa.eu/system/files/documents/report/meeting-report-joint-ema-eortc-workshop-soft-tissue-bone-sarcoma-workshop_en.pdfMon, 06 May 2024 14:45:31 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/comp-minutes-12-14-march-2024_en.pdfMinutes of the COMP meeting 12-14 March 2024https://www.ema.europa.eu/system/files/documents/minutes/comp-minutes-12-14-march-2024_en.pdfMon, 06 May 2024 13:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/synapseReferral: Synapse Article 31 referrals CHMP opinion, 21/03/2024, 06/05/2024https://www.ema.europa.eu/en/medicines/human/referrals/synapseMon, 06 May 2024 12:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/adynoviHuman medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Date of authorisation: 08/01/2018, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/adynoviMon, 06 May 2024 11:43:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/advateHuman medicines European public assessment report (EPAR): Advate, octocog alfa, Date of authorisation: 02/03/2004, Revision: 32, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/advateMon, 06 May 2024 11:39:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/ctis-structured-data-form-additional-msc-sm-non-sm_en.xlsxClinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationhttps://www.ema.europa.eu/system/files/documents/template-form/ctis-structured-data-form-additional-msc-sm-non-sm_en.xlsxMon, 06 May 2024 11:37:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_5.xlsxList of signals discussed at PRAC since September 2012https://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_5.xlsxMon, 06 May 2024 10:33:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/prac-recommendations-signals-adopted-8-11-april-2024-prac_en.pdfPRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetinghttps://www.ema.europa.eu/system/files/documents/other/prac-recommendations-signals-adopted-8-11-april-2024-prac_en.pdfMon, 06 May 2024 09:36:49 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiHuman medicines European public assessment report (EPAR): MenQuadfi, meningococcal group A, C, W-135 and Y conjugate vaccine, Date of authorisation: 18/11/2020, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiFri, 03 May 2024 16:41:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002754-pip01-19EMEA-002754-PIP01-19https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002754-pip01-19Fri, 03 May 2024 16:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002693-pip01-19EMEA-002693-PIP01-19https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002693-pip01-19Fri, 03 May 2024 16:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003157-pip01-21EMEA-003157-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003157-pip01-21Fri, 03 May 2024 16:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001666-pip01-14-m01EMEA-001666-PIP01-14-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001666-pip01-14-m01Fri, 03 May 2024 16:08:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods_adjusted_en.pdfAgenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodshttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods_adjusted_en.pdfFri, 03 May 2024 15:44:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/external-agenda-12th-meeting-industry-stakeholder-platform-operation-ce_en.pdfAgenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicineshttps://www.ema.europa.eu/system/files/documents/agenda/external-agenda-12th-meeting-industry-stakeholder-platform-operation-ce_en.pdfFri, 03 May 2024 14:30:00 +0200What's newhttps://www.ema.europa.eu/en/events/third-european-medicines-agency-affordable-medicines-europe-bilateral-meetingThird European Medicines Agency and Affordable Medicines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 April 2024https://www.ema.europa.eu/en/events/third-european-medicines-agency-affordable-medicines-europe-bilateral-meetingFri, 03 May 2024 14:09:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/briumviHuman medicines European public assessment report (EPAR): Briumvi, ublituximab, Date of authorisation: 31/05/2023, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/briumviFri, 03 May 2024 12:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm23-quick-guide_sponsor_en.pdfSponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23https://www.ema.europa.eu/system/files/documents/other/cttm23-quick-guide_sponsor_en.pdfFri, 03 May 2024 12:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tevimbraHuman medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tevimbraFri, 03 May 2024 12:09:00 +0200What's newhttps://www.ema.europa.eu/en/events/qa-clinic-iris-network-users-transitioned-regulatory-proceduresQ&A Clinic for IRIS Network users for transitioned regulatory procedures, Online, from 23 May 2024, 11:00 (CEST) to 23 May 2024, 12:00 (CEST)https://www.ema.europa.eu/en/events/qa-clinic-iris-network-users-transitioned-regulatory-proceduresFri, 03 May 2024 11:16:53 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sivextroHuman medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Date of authorisation: 23/03/2015, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sivextroFri, 03 May 2024 10:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/talzennaHuman medicines European public assessment report (EPAR): Talzenna, talazoparib, Date of authorisation: 20/06/2019, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/talzennaFri, 03 May 2024 10:48:00 +0200What's newhttps://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guidelineICH M10 on bioanalytical method validation - Scientific guidelinehttps://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guidelineFri, 03 May 2024 10:45:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificatesPlasma master file certificateshttps://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificatesFri, 03 May 2024 10:45:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/real-world-evidenceReal-world evidencehttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/real-world-evidenceFri, 03 May 2024 09:55:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/how-we-work/big-dataBig datahttps://www.ema.europa.eu/en/about-us/how-we-work/big-dataFri, 03 May 2024 09:55:00 +0200What's newhttps://www.ema.europa.eu/en/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-scientific-guidelineReflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guidelinehttps://www.ema.europa.eu/en/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-scientific-guidelineFri, 03 May 2024 09:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/reflection-paper-real-world-evidence_draft-public-consultation_may_august_2024_en.pdfReflection paper on use of real-world data in non-interventional studies to generate real-world evidencehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/reflection-paper-real-world-evidence_draft-public-consultation_may_august_2024_en.pdfFri, 03 May 2024 09:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/template-scientific-document_part-b-f_en.docxTemplate for scientific document (part B-F)https://www.ema.europa.eu/system/files/documents/template-form/template-scientific-document_part-b-f_en.docxThu, 02 May 2024 16:29:00 +0200What's newhttps://www.ema.europa.eu/en/events/cvmp-interested-parties-meeting-4CVMP Interested Parties’ meeting, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2024, 17:00 (CEST) to 22 May 2024, 19:00 (CEST)https://www.ema.europa.eu/en/events/cvmp-interested-parties-meeting-4Thu, 02 May 2024 16:26:53 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/publication-atmp-classification-recommendations-q1-2024_apr-2024_en.xlsxScientific recommendations on classification of advanced therapy medicinal productshttps://www.ema.europa.eu/system/files/documents/other/publication-atmp-classification-recommendations-q1-2024_apr-2024_en.xlsxThu, 02 May 2024 16:26:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/nitrosamines-qa_appendix1_excel-ema-rev-4_en.xlsxAppendix 1: Acceptable intakes established for N-nitrosamineshttps://www.ema.europa.eu/system/files/documents/other/nitrosamines-qa_appendix1_excel-ema-rev-4_en.xlsxThu, 02 May 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/who-we-are/information-managementInformation Managementhttps://www.ema.europa.eu/en/about-us/who-we-are/information-managementThu, 02 May 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/malvae-sylvestris-flosHerbal medicinal product: Malvae sylvestris flosArray, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/malvae-sylvestris-flosThu, 02 May 2024 15:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pelmegHuman medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pelmegThu, 02 May 2024 15:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/noxafilHuman medicines European public assessment report (EPAR): Noxafil, posaconazole, Date of authorisation: 25/10/2005, Revision: 38, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/noxafilThu, 02 May 2024 15:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accordHuman medicines European public assessment report (EPAR): Teriflunomide Accord, teriflunomide, Date of authorisation: 09/11/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accordThu, 02 May 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/byoovizHuman medicines European public assessment report (EPAR): Byooviz, ranibizumab, Date of authorisation: 18/08/2021, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/byoovizThu, 02 May 2024 15:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pluvictoHuman medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Date of authorisation: 09/12/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pluvictoThu, 02 May 2024 15:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rotateqHuman medicines European public assessment report (EPAR): RotaTeq, rotavirus vaccine, live, Date of authorisation: 26/06/2006, Revision: 37, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rotateqThu, 02 May 2024 15:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tracleerHuman medicines European public assessment report (EPAR): Tracleer, bosentan, Date of authorisation: 14/05/2002, Revision: 43, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tracleerThu, 02 May 2024 15:02:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/stayveerHuman medicines European public assessment report (EPAR): Stayveer, bosentan monohydrate, Date of authorisation: 24/06/2013, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/stayveerThu, 02 May 2024 14:54:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/nirs-scope-addendum-nir-guideline-revised-clean_en.pdfAddendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedurehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/nirs-scope-addendum-nir-guideline-revised-clean_en.pdfThu, 02 May 2024 14:50:47 +0200What's newhttps://www.ema.europa.eu/en/events/eu-ntc-ten-year-anniversary-eventEU NTC ten year anniversary event, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 30 May 2024, 09:00 (CEST) to 30 May 2024, 16:30 (CEST)https://www.ema.europa.eu/en/events/eu-ntc-ten-year-anniversary-eventThu, 02 May 2024 14:46:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/volibrisHuman medicines European public assessment report (EPAR): Volibris, ambrisentan, Date of authorisation: 20/04/2008, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/volibrisThu, 02 May 2024 14:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/malvae-foliumHerbal medicinal product: Malvae foliumArray,Array, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/malvae-foliumThu, 02 May 2024 14:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vafseoHuman medicines European public assessment report (EPAR): Vafseo, vadadustat, Date of authorisation: 24/04/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vafseoThu, 02 May 2024 14:31:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/incellipanHuman medicines European public assessment report (EPAR): Incellipan, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/incellipanThu, 02 May 2024 14:25:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/how-we-work/handling-competing-interestsHandling competing interestshttps://www.ema.europa.eu/en/about-us/how-we-work/handling-competing-interestsThu, 02 May 2024 14:04:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/celldemicHuman medicines European public assessment report (EPAR): Celldemic, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/celldemicThu, 02 May 2024 13:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zynyz-0Human medicines European public assessment report (EPAR): Zynyz, retifanlimab, Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zynyz-0Thu, 02 May 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/committee-report/cat-quarterly-highlights-approved-atmps-february-april-2024_en.pdfCAT quarterly highlights and approved ATMPs - February - April 2024https://www.ema.europa.eu/system/files/documents/committee-report/cat-quarterly-highlights-approved-atmps-february-april-2024_en.pdfThu, 02 May 2024 11:11:01 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-answers-part-1Quality of medicines questions and answers: Part 1https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-answers-part-1Thu, 02 May 2024 09:42:00 +0200What's newhttps://www.ema.europa.eu/en/stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products-scientific-guidelineStability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guidelinehttps://www.ema.europa.eu/en/stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products-scientific-guidelineThu, 02 May 2024 09:29:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/guideline-stability-variations-vmps_en.pdfGuideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productshttps://www.ema.europa.eu/system/files/documents/scientific-guideline/guideline-stability-variations-vmps_en.pdfThu, 02 May 2024 09:25:30 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mirapexinHuman medicines European public assessment report (EPAR): Mirapexin, pramipexole, Date of authorisation: 23/02/1998, Revision: 42, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mirapexinThu, 02 May 2024 09:18:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/concept-paper-revision-gl-risk-assessment-human-reproduction-lactation-pc_2_en.pdfConcept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labellinghttps://www.ema.europa.eu/system/files/documents/scientific-guideline/concept-paper-revision-gl-risk-assessment-human-reproduction-lactation-pc_2_en.pdfThu, 02 May 2024 09:10:57 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-eligible-industry-stakeholder-organisations_en_1.pdfList of eligible industry stakeholder organisationshttps://www.ema.europa.eu/system/files/documents/other/list-eligible-industry-stakeholder-organisations_en_1.pdfThu, 02 May 2024 08:48:00 +0200What's new