DateContentStatus
18/03/2024 Page: Transferring a veterinary marketing authorisationUpdated
18/03/2024 Page: EudraVigilance system overviewUpdated
18/03/2024 Document: Template - Application for transfer of marketing authorisation from transferor to transferee, cover letterNew
18/03/2024 Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 2New
18/03/2024 Event: Product Management Service (PMS) Info-DayNew
18/03/2024 Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1New
18/03/2024 Event: Orphan medicines development - ask the European regulatorUpdated
18/03/2024 Medicine: VimpatUpdated
18/03/2024 Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm+EDSNew
18/03/2024 Medicine: TrilocurNew
18/03/2024 Medicine: Divence TetraNew
18/03/2024 Medicine: LotimaxNew
18/03/2024 Medicine: TriloraleNew
18/03/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024New
18/03/2024 Post-authorisation: Prevexxion RN+HVT+IBD - opinion on variation to marketing authorisationNew
18/03/2024 Page: Website outages and upgradesUpdated
18/03/2024 Medicine: EpysqliUpdated
18/03/2024 Page: Union Product Database: release notesUpdated
18/03/2024 Document: Agenda of the CHMP meeting 18-21 March 2024New
15/03/2024 Medicine: BosulifUpdated
15/03/2024 Medicine: PhelinunUpdated
15/03/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2024Updated
15/03/2024 Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meetingUpdated
15/03/2024 Medicine: AccofilUpdated
15/03/2024 Medicine: SkyriziUpdated
15/03/2024 Page: Scientific publicationsUpdated
15/03/2024 PSUSA: PSUSA/00002060/202305 - periodic safety update report single assessmentNew
15/03/2024 Medicine: VidPrevtyn BetaUpdated
14/03/2024 Page: Industry annual bilateral meetingsUpdated
14/03/2024 Event: Third European Medicines Agency (EMA) and MedTech Europe bilateral meetingUpdated
14/03/2024 Page: Union Product DatabaseUpdated
14/03/2024 Document: Record of data processing activity relating to Security Access Control System (public)Updated
14/03/2024 Medicine: Lacosamide AdroiqUpdated
14/03/2024 Document: New Organization First User QPPV/RP or Change of EU QPPV/RPUpdated
14/03/2024 Medicine: Methylthioninium chloride ProveblueUpdated
14/03/2024 Document: EudraVigilance registration documentsUpdated
14/03/2024 Document: EudraVigilance registration manualUpdated
14/03/2024 Page: Data protection and privacyUpdated
14/03/2024 Medicine: PaxlovidUpdated
14/03/2024 Medicine: TalveyUpdated
14/03/2024 Document: Record of data processing activity relating to personal files (public)Updated
14/03/2024 Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control SystemUpdated
14/03/2024 Event: EMA Veterinary Medicines Info Day 2024Updated
14/03/2024 Medicine: VijoiceUpdated
14/03/2024 PSUSA: PSUSA/00010271/202307 - periodic safety update report single assessmentNew
14/03/2024 Medicine: RetsevmoUpdated
14/03/2024 Medicine: SustivaUpdated
13/03/2024 PIP: EMEA-001214-PIP07-21 - paediatric investigation planNew
13/03/2024 Document: Member states contact points for translations reviewUpdated
13/03/2024 PIP: EMEA-001214-PIP04-19 - paediatric investigation planNew
13/03/2024 PIP: EMEA-002229-PIP02-21 - paediatric investigation planNew
13/03/2024 Page: Eligible patients and consumers organisationsUpdated
13/03/2024 PIP: EMEA-002239-PIP02-21 - paediatric investigation planNew
13/03/2024 PIP: EMEA-001196-PIP03-21 - paediatric investigation planNew
13/03/2024 Medicine: ImjudoUpdated
13/03/2024 PIP: EMEA-002431-PIP02-21 - paediatric investigation planNew
13/03/2024 Page: Proline - Scientific guidelineUpdated
13/03/2024 Page: Supporting innovationUpdated
13/03/2024 PIP: EMEA-002839-PIP01-20-M01 - paediatric investigation planUpdated
13/03/2024 Event: Quarterly System Demo Q1 2024Updated
13/03/2024 PIP: EMEA-002700-PIP01-19-M01 - paediatric investigation planUpdated
13/03/2024 Event: EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?Updated
13/03/2024 Medicine: XevudyUpdated
13/03/2024 Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca)Updated
13/03/2024 Medicine: BlenrepUpdated
13/03/2024 Medicine: IlarisUpdated
13/03/2024 Document: Blenrep : EPAR - Public assessment reportUpdated
13/03/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
13/03/2024 Medicine: KrazatiUpdated
13/03/2024 Document: Innovation Task Force (ITF) briefing meeting request formUpdated
13/03/2024 Event: Paediatric Committee (PDCO): 16-19 January 2024Updated
13/03/2024 Event: Committee for Advanced Therapies (CAT): 13-15 March 2024Updated
13/03/2024 Orphan: EU/3/05/314 - orphan designation for treatment of tuberculosisUpdated
13/03/2024 Medicine: SirturoUpdated
12/03/2024 Event: Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reportingUpdated
12/03/2024 Event: CTIS Bitesize Talk: How to submit a transitional trial in CTISUpdated
12/03/2024 Medicine: Pomalidomide ViatrisUpdated
12/03/2024 Medicine: Prevenar 20 (previously Apexxnar)Updated
12/03/2024 PSUSA: PSUSA/00000906/202305 - periodic safety update report single assessmentNew
12/03/2024 PSUSA: PSUSA/00010913/202306 - periodic safety update report single assessmentNew
12/03/2024 Medicine: StriascanUpdated
12/03/2024 Page: Coordination of pharmacovigilance inspectionsUpdated
12/03/2024 Document: Applications for new human medicines under evaluation: March 2024New
12/03/2024 Document: DARWIN EU Advisory Board: MembershipUpdated
12/03/2024 Medicine: Ibuprofen Gen.OrphUpdated
12/03/2024 Medicine: EvkeezaUpdated
12/03/2024 Medicine: DaxasUpdated
12/03/2024 Medicine: VerzeniosUpdated
12/03/2024 Medicine: KaftrioUpdated
12/03/2024 Medicine: IdefirixUpdated
11/03/2024 Medicine: Pramipexole AccordUpdated
11/03/2024 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024Updated
11/03/2024 Medicine: UpstazaUpdated
11/03/2024 Medicine: Innovax-ILT-IBDNew
11/03/2024 Medicine: Prevexxion RN+HVTNew
11/03/2024 Medicine: Eurican L4New
11/03/2024 Medicine: XultophyUpdated
11/03/2024 Medicine: NexviadymeUpdated
11/03/2024 Medicine: ComirnatyUpdated
11/03/2024 Herbal: Symphyti radix - herbal medicinal productUpdated
11/03/2024 Document: Agenda of the COMP meeting 12-14 March 2024New
11/03/2024 Event: Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2024Updated
11/03/2024 Page: Product-specific bioequivalence guidanceUpdated
11/03/2024 Document: Minutes of the CHMP meeting 22-25 January 2024New
11/03/2024 Document: Procedural advice for orphan medicinal product designation: Guidance for sponsorsUpdated
11/03/2024 Document: Fludarabine supply shortageNew
08/03/2024 Medicine: EmendUpdated
08/03/2024 PSUSA: PSUSA/00010007/202307 - periodic safety update report single assessmentNew
08/03/2024 Medicine: Prevenar 13Updated
08/03/2024 PIP: EMEA-001397-PIP04-17-M01 - paediatric investigation planUpdated
08/03/2024 PIP: EMEA-001312-PIP02-19 - paediatric investigation planUpdated
08/03/2024 PIP: EMEA-001312-PIP03-19 - paediatric investigation planUpdated
08/03/2024 PSUSA: PSUSA/00001738/202307 - periodic safety update report single assessmentNew
08/03/2024 Medicine: ZalastaUpdated
08/03/2024 Medicine: KinpeygoUpdated
08/03/2024 Medicine: SkyclarysUpdated
08/03/2024 Medicine: EliquisUpdated
08/03/2024 Medicine: IvemendUpdated
08/03/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024New
08/03/2024 Medicine: QuofenixUpdated
08/03/2024 Medicine: HyQviaUpdated
08/03/2024 Page: Liposomal amphotericin B product-specific bioequivalence guidanceUpdated
08/03/2024 Document: Note on the HORIZON-JU-IHI-2024-06-two-stage funding call: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidenceNew
07/03/2024 Page: Scientific and technical recommendations: Veterinary Medicines RegulationUpdated
07/03/2024 Document: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilanceUpdated
07/03/2024 Document: EudraVigilance Form AUpdated
07/03/2024 Document: Connection template - EMA ESTRI Gateway using an AS2 compatible productUpdated
07/03/2024 Document: Connecting to the Agency ESTRI Gateway using an AS2 compatible productUpdated
07/03/2024 Document: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedureUpdated
07/03/2024 Document: EudraVigilance - EVWEB user manualUpdated
07/03/2024 Document: EudraVigilance support guideUpdated
07/03/2024 PSUSA: PSUSA/00002151/202308 - periodic safety update report single assessmentNew
07/03/2024 PSUSA: PSUSA/00011039/202307 - periodic safety update report single assessmentNew
07/03/2024 PSUSA: PSUSA/00000210/202308 - periodic safety update report single assessmentNew
07/03/2024 Page: Vaccine Monitoring PlatformUpdated
07/03/2024 Medicine: ImbruvicaUpdated
07/03/2024 PIP: EMEA-002440-PIP01-18-M04 - paediatric investigation planUpdated
07/03/2024 Document: Vaccine Monitoring Platform: List of EMA-funded studiesNew
07/03/2024 Event: Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studiesUpdated
07/03/2024 PIP: EMEA-002435-PIP01-18-M03 - paediatric investigation planUpdated
07/03/2024 PIP: EMEA-002298-PIP01-17-M05 - paediatric investigation planUpdated
07/03/2024 Medicine: MekinistUpdated
07/03/2024 Document: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025Updated
07/03/2024 Medicine: TafinlarUpdated
07/03/2024 Document: Meeting Report of the second Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)New
07/03/2024 Page: Big dataUpdated
07/03/2024 Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024New
07/03/2024 Event: 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work planUpdated
07/03/2024 PIP: EMEA-003341-PIP01-22 - paediatric investigation planNew
07/03/2024 PIP: EMEA-003342-PIP01-22 - paediatric investigation planNew
07/03/2024 PIP: EMEA-003340-PIP01-22 - paediatric investigation planNew
07/03/2024 Page: Opinions and letters of support on the qualification of novel methodologies for medicine developmentUpdated
06/03/2024 Medicine: MounjaroUpdated
06/03/2024 Medicine: ApealeaUpdated
06/03/2024 Medicine: DopteletUpdated
06/03/2024 Medicine: RevestiveUpdated
06/03/2024 Page: Data Analysis and Real World Interrogation Network (DARWIN EU)Updated
06/03/2024 Document: DARWIN EU data partners onboarded in phases I and IIUpdated
06/03/2024 Document: DARWIN EU: Making health data countNew
06/03/2024 News: DARWIN EU® continues expanding its capacity to deliver real-world data studiesNew
06/03/2024 PSUSA: PSUSA/00001504/202304 - periodic safety update report single assessmentNew
06/03/2024 Medicine: CholibUpdated
06/03/2024 Document: List of signals discussed at PRAC since September 2012Updated
06/03/2024 Document: PRAC recommendations on signals adopted at the 5-8 February 2024 PRAC meetingNew
05/03/2024 Medicine: FilspariUpdated
05/03/2024 Medicine: DynastatUpdated
05/03/2024 Medicine: VeraSealUpdated
05/03/2024 Herbal: Silybi mariani fructus - herbal medicinal productUpdated
05/03/2024 Document: Minutes of the PRAC meeting 8-11 January 2024New
05/03/2024 Medicine: EnhertuUpdated
05/03/2024 Page: Templates for assessorsUpdated
05/03/2024 Document: CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46Updated
05/03/2024 Document: Assessment report for post-authorisation measures (PAMs)Updated
05/03/2024 Medicine: Clopidogrel TADUpdated
05/03/2024 Medicine: ImcivreeUpdated
05/03/2024 Medicine: KalydecoUpdated
05/03/2024 Medicine: AmeluzUpdated
05/03/2024 Medicine: VafseoUpdated
05/03/2024 Event: Sixth European Medicines Agency (EMA) and EFPIA bilateral meetingUpdated
05/03/2024 Medicine: OtezlaUpdated
05/03/2024 Medicine: DupixentUpdated
05/03/2024 Document: CHMP PROM minutes for the meeting on 12 February 2024New
05/03/2024 Document: CHMP PROM minutes for the meeting on 15 January 2024New
04/03/2024 Medicine: AclastaUpdated
04/03/2024 PSUSA: PSUSA/00001506/202304 - periodic safety update report single assessmentNew
04/03/2024 Document: Agenda of the PRAC meeting 4-7 March 2024New
04/03/2024 Medicine: ZyclaraUpdated
04/03/2024 Event: Eight Nitrosamine Implementation Oversight Group (NIOG) meetingNew
04/03/2024 Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan)Updated
04/03/2024 Page: Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'Updated
04/03/2024 Event: Training webinar on the use of Scientific Explorer in scientific advice regulatory proceduresNew
04/03/2024 EU-M4all: Dapivirine Vaginal Ring 25 mgUpdated
04/03/2024 Medicine: ReblozylUpdated
04/03/2024 Page: Procedures for monograph and list entry establishmentUpdated
04/03/2024 Herbal: Gentianae radix - herbal medicinal productUpdated
04/03/2024 Herbal: Calendulae flos - herbal medicinal productUpdated
04/03/2024 Herbal: Boldi folium - herbal medicinal productUpdated
04/03/2024 Herbal: Avenae herba - herbal medicinal productUpdated
04/03/2024 Herbal: Avenae fructus - herbal medicinal productUpdated
01/03/2024 Herbal: Lupuli flos - herbal medicinal productUpdated
01/03/2024 Herbal: Lini semen - herbal medicinal productUpdated
01/03/2024 Herbal: Combination: Thymi herba and Primulae radix - herbal medicinal productUpdated
01/03/2024 Herbal: Rusci rhizoma - herbal medicinal productUpdated
01/03/2024 Herbal: Sambuci flos - herbal medicinal productUpdated
01/03/2024 Document: ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1New
01/03/2024 PSUSA: PSUSA-00002110-202305 - periodic safety update report single assessmentNew
01/03/2024 PSUSA: PSUSA/00000613/202305 - periodic safety update report single assessmentNew
01/03/2024 PSUSA: PSUSA/00001500/202304 - periodic safety update report single assessmentNew
01/03/2024 Medicine: ZinplavaUpdated
01/03/2024 Medicine: MabTheraUpdated
01/03/2024 Medicine: RxultiUpdated
01/03/2024 Medicine: BlincytoUpdated
01/03/2024 Medicine: SaxendaUpdated
01/03/2024 Document: List of centrally authorised products requiring a notification of a change for update of annexesUpdated
01/03/2024 Medicine: ToviazUpdated
01/03/2024 Herbal: Foeniculi dulcis fructus - herbal medicinal productUpdated
01/03/2024 Herbal: Foeniculi amari fructus - herbal medicinal productUpdated
01/03/2024 Document: QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)Updated
01/03/2024 Medicine: AldaraUpdated
01/03/2024 Page: Network PortfolioUpdated
01/03/2024 Medicine: TepadinaUpdated
01/03/2024 Document: Organisation chart: Information ManagementUpdated
01/03/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2024Updated
01/03/2024 Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (29 January 2024)New
01/03/2024 Document: Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))Updated
01/03/2024 Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 February 2024New
01/03/2024 Document: List of medicines currently in PRIME schemeUpdated