DateContentStatus
06/12/2024 Referral: Metamizole-containing medicinal products - referralUpdated
06/12/2024 Event: Q&A Clinic on post-authorisation procedure management in IRIS (2)New
06/12/2024 Page: Quality of medicines questions and answers: Part 1Updated
06/12/2024 Event: European Commission/EMA meeting with stakeholders on Translarna (ataluren)New
06/12/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024New
06/12/2024 Medicine: Icthiovac ERMNew
06/12/2024 Medicine: Poulvac Procerta HVT-IBD-ND New
06/12/2024 Medicine: Tolfenamic acid VMDNew
06/12/2024 Document: European Medicines Agency’s data protection notice regarding the experts database and the handling of competing interests of scientific committees’ members and expertsUpdated
06/12/2024 Medicine: LixianaUpdated
06/12/2024 Medicine: VotubiaUpdated
06/12/2024 Page: Artificial intelligenceUpdated
06/12/2024 Document: Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trialsNew
06/12/2024 Event: Q&A Clinic on post-authorisation procedure management in IRIS (1)New
06/12/2024 Medicine: Bemrist BreezhalerUpdated
06/12/2024 Medicine: Atectura BreezhalerUpdated
06/12/2024 Referral: Finasteride- and dutasteride-containing medicinal products - referralUpdated
05/12/2024 Medicine: TafinlarUpdated
05/12/2024 Event: 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA) Updated
05/12/2024 Event: 2024 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)New
05/12/2024 Medicine: Pregabalin Viatris (previously Pregabalin Mylan)Updated
05/12/2024 Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRACUpdated
05/12/2024 DHPC: Ibandronic acid Accord - direct healthcare professional communication (DHPC)New
05/12/2024 Medicine: MekinistUpdated
05/12/2024 Medicine: Alli (previously Orlistat GSK)Updated
05/12/2024 Medicine: HemgenixUpdated
05/12/2024 Medicine: Vantavo (previously Alendronate sodium and colecalciferol, MSD)Updated
05/12/2024 Medicine: AdrovanceUpdated
05/12/2024 Medicine: EsperoctUpdated
05/12/2024 Medicine: PyzchivaUpdated
05/12/2024 Medicine: Nexium ControlUpdated
05/12/2024 Medicine: SpexotrasUpdated
05/12/2024 Medicine: BaqsimiUpdated
05/12/2024 Medicine: Posaconazole AccordUpdated
05/12/2024 Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guidelineUpdated
05/12/2024 Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathiesUpdated
05/12/2024 Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2024Updated
05/12/2024 Medicine: SupemtekUpdated
05/12/2024 Medicine: Arsenic trioxide AccordUpdated
05/12/2024 Document: Guidance for applicants seeking scientific support and advice on traditional herbal medicinal productsUpdated
05/12/2024 Medicine: OvaleapUpdated
05/12/2024 Medicine: MoventigUpdated
05/12/2024 Medicine: TheralugandUpdated
05/12/2024 Medicine: FosavanceUpdated
05/12/2024 Medicine: KevzaraUpdated
05/12/2024 Event: Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS)Updated
05/12/2024 Event: UPD refresher webinar for marketing authorisation holders on volume of sales submissionUpdated
05/12/2024 Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilanceUpdated
05/12/2024 Document: Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC)Updated
05/12/2024 Document: Data protection notice for the Experts Management Tool and the handling of competing interestsNew
05/12/2024 Medicine: Jcovden (previously COVID-19 Vaccine Janssen)Updated
05/12/2024 Document: Jcovden : Periodic safety update report assessment 25 February 2023 to 24 February 2024New
04/12/2024 Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)Updated
04/12/2024 Medicine: ErleadaUpdated
04/12/2024 Event: Seventh European Medicines Agency (EMA) and EFPIA bilateral meeting Updated
04/12/2024 Medicine: AdvateUpdated
04/12/2024 Medicine: KovaltryUpdated
04/12/2024 Medicine: Duloxetine Viatris (previously Duloxetine Mylan)Updated
04/12/2024 Page: How to payUpdated
04/12/2024 Document: How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicantsNew
04/12/2024 PSUSA: PSUSA/00000772/202404 - periodic safety update report single assessmentNew
04/12/2024 Medicine: BimervaxUpdated
04/12/2024 Document: Bimervax: Periodic safety update report assessment 30 March 2023 to 29 September 2023New
04/12/2024 Document: EVVet3 EVWeb Production - Release notesUpdated
04/12/2024 Document: Record of data processing activity relating to Security Access Control SystemUpdated
04/12/2024 Document: European Medicines Agency’s data protection notice for the operation of the Security Access Control SystemUpdated
04/12/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
04/12/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 5 December 2024New
04/12/2024 Page: Clinical requirements for non replacement therapy in haemophilia A and B - Scientific guidelineUpdated
04/12/2024 Document: Medicine shortage mitigation plan - templateUpdated
04/12/2024 Document: Medicine shortage prevention plan - templateUpdated
04/12/2024 Medicine: MenveoUpdated
04/12/2024 Medicine: ScintimunUpdated
04/12/2024 Medicine: OcalivaUpdated
04/12/2024 Document: Scintimun-H-C-PSUSA-00000385-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisationNew
04/12/2024 Page: Submission deadlines for orphan designationsUpdated
04/12/2024 Document: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025Updated
03/12/2024 Medicine: Bevespi AerosphereUpdated
03/12/2024 Document: List of substances and products subject to worksharing for signal managementUpdated
03/12/2024 Medicine: TauvidUpdated
03/12/2024 Medicine: ZolgensmaUpdated
03/12/2024 Medicine: EnhertuUpdated
03/12/2024 Document: Pediatric Cluster Terms of ReferenceUpdated
03/12/2024 Medicine: FluadUpdated
03/12/2024 Medicine: CelsentriUpdated
03/12/2024 Medicine: XolairUpdated
03/12/2024 Medicine: CasgevyUpdated
03/12/2024 Referral: Ocaliva - referralUpdated
03/12/2024 Medicine: TasignaUpdated
03/12/2024 Event: Translating innovation into access for ATMPs: third EU-Innovation network multi-stakeholder meetingUpdated
03/12/2024 Orphan: EU/3/23/2828 - orphan designation for treatment of transthyretin-mediated amyloidosisUpdated
03/12/2024 Medicine: Briviact (in Italy: Nubriveo)Updated
03/12/2024 Document: Briviact-H-C-PSUSA-00010447-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisationNew
03/12/2024 Event: EU NTC ten year anniversary eventUpdated
03/12/2024 Document: Report - EU NTC ten year anniversary eventNew
03/12/2024 Event: Quarterly system demo - Q4 2024Updated
03/12/2024 Medicine: KimmtrakUpdated
03/12/2024 Page: Clinical evaluation of medicinal products used in weight control - Scientific guidelineUpdated
03/12/2024 Document: Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control New
03/12/2024 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 December 2024Updated
03/12/2024 Document: Agenda of the COMP meeting 3-5 December 2024New
03/12/2024 Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product informationUpdated
03/12/2024 Medicine: LumykrasUpdated
03/12/2024 Document: Lumykras : EPAR - Risk management planNew
03/12/2024 Document: Agenda of the CVMP meeting 3-5 December 2024New
03/12/2024 Document: Record of data processing activity for the Experts Management Tool and the handling of competing interestsUpdated
03/12/2024 Document: Expected publication dates of PRAC recommendations on safety signalsUpdated
03/12/2024 DHPC: Metamizole - direct healthcare professional communication (DHPC)New
03/12/2024 Orphan: EU/3/16/1752 - orphan designation for treatment of haemophilia AUpdated
02/12/2024 Medicine: Eribulin BaxterUpdated
02/12/2024 Medicine: TavlesseUpdated
02/12/2024 PSUSA: PSUSA/00002204/202404 - periodic safety update report single assessmentNew
02/12/2024 Medicine: Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)Updated
02/12/2024 Medicine: NustendiUpdated
02/12/2024 Medicine: NilemdoUpdated
02/12/2024 Medicine: CabliviUpdated
02/12/2024 Medicine: Prevexxion RN+HVT+IBDUpdated
02/12/2024 Page: National competent authorities (human)Updated
02/12/2024 Medicine: MetacamUpdated
02/12/2024 Medicine: SancusoUpdated
02/12/2024 Medicine: Frontpro (previously known as Afoxolaner Merial)Updated
02/12/2024 Medicine: CerezymeUpdated
02/12/2024 Medicine: DupixentUpdated
02/12/2024 Event: Committee for Advanced Therapies (CAT): 4-6 December 2024Updated
02/12/2024 Medicine: FabhaltaUpdated
02/12/2024 Document: Agenda of the CAT meeting 4-6 December 2024New
02/12/2024 Document: Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activitiesUpdated
02/12/2024 Document: QRD Appendix I - Adverse event (PhV) MSs reporting detailsUpdated
02/12/2024 Event: Paediatric Committee (PDCO): 15-18 October 2024Updated
02/12/2024 Document: Minutes - PDCO minutes of the 15-18 October 2024 meetingNew
02/12/2024 Event: Thirteenth meeting of the industry stakeholder platform on research and development supportNew