DateContentStatus
05/07/2024 Medicine: ObgemsaUpdated
05/07/2024 PIP: EMEA-000380-PIP10-23 - paediatric investigation planNew
05/07/2024 PIP: EMEA-002961-PIP01-21-M02 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-002899-PIP01-20-M02 - paediatric investigation planUpdated
05/07/2024 Medicine: OlumiantUpdated
05/07/2024 Medicine: MektoviUpdated
05/07/2024 PIP: EMEA-002762-PIP02-20-M01 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-002735-PIP03-20-M02 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-002735-PIP01-19-M01 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-002563-PIP02-19-M02 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-002229-PIP02-21-M01 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001900-PIP02-17-M07 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001766-PIP01-15-M05 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001741-PIP01-14-M06 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001627-PIP01-14-M03 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001299-PIP03-17-M02 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001220-PIP01-11-M08 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001150-PIP02-13-M05 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-001089-PIP02-13-M04 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000902-PIP01-10-M01 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000798-PIP01-09-M04 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000551-PIP04-21-M02 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000468-PIP02-12-M08 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000347-PIP02-16-M05 - paediatric investigation planUpdated
05/07/2024 PIP: EMEA-000207-PIP01-08-M08 - paediatric investigation planUpdated
05/07/2024 Referral: Hydroxyprogesterone caproate-containing medicinal products - referralUpdated
05/07/2024 Medicine: Dovprela (previously Pretomanid FGK)Updated
05/07/2024 Medicine: ComirnatyUpdated
05/07/2024 Document: 2023 annual report of the European Medicines AgencyUpdated
05/07/2024 Page: Pharmacovigilance fees payable to the European Medicines AgencyUpdated
05/07/2024 PSUSA: PSUSA/00000059/202309 - periodic safety update report single assessmentUpdated
05/07/2024 PSUSA: PSUSA/00010342/202309 - periodic safety update report single assessmentUpdated
05/07/2024 Medicine: MounjaroUpdated
05/07/2024 Page: Fees payable to the European Medicines AgencyUpdated
05/07/2024 Document: New Fee Regulation working arrangementsNew
05/07/2024 Medicine: ZometaUpdated
05/07/2024 Document: Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2New
05/07/2024 Medicine: BaracludeUpdated
04/07/2024 Referral: Azithromycin-containing medicinal products for systemic use - referralUpdated
04/07/2024 Medicine: LeqvioUpdated
04/07/2024 Medicine: TecentriqUpdated
04/07/2024 Medicine: SotyktuUpdated
04/07/2024 Medicine: EsperoctUpdated
04/07/2024 Medicine: GrasustekUpdated
04/07/2024 PIP: EMEA-003149-PIP01-21-M01 - paediatric investigation planUpdated
04/07/2024 PIP: EMEA-003001-PIP01-21-M01 - paediatric investigation planUpdated
04/07/2024 PIP: EMEA-002942-PIP02-20-M01 - paediatric investigation planUpdated
04/07/2024 PIP: EMEA-002935-PIP01-20-M03 - paediatric investigation planUpdated
04/07/2024 Medicine: Abilify MaintenaUpdated
04/07/2024 Medicine: Abiraterone AccordUpdated
04/07/2024 PIP: EMEA-002443-PIP01-18-M02 - paediatric investigation planUpdated
04/07/2024 PIP: EMEA-002705-PIP01-19-M01 - paediatric investigation planUpdated
04/07/2024 PIP: EMEA-002597-PIP05-21-M01 - paediatric investigation planUpdated
04/07/2024 Medicine: SpinrazaUpdated
04/07/2024 Medicine: BuccolamUpdated
04/07/2024 News: Recent additions to EMA’s management teamNew
04/07/2024 Medicine: UltomirisUpdated
04/07/2024 Page: Advisory functionsUpdated
04/07/2024 Document: Appendix 1: Acceptable intakes established for N-nitrosaminesUpdated
04/07/2024 Medicine: Spikevax (previously COVID-19 Vaccine Moderna)Updated
04/07/2024 Medicine: Emtricitabine/Tenofovir disoproxil KrkaUpdated
03/07/2024 Medicine: OrkambiUpdated
03/07/2024 Medicine: RozlytrekUpdated
03/07/2024 Medicine: CamzyosUpdated
03/07/2024 Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)Updated
03/07/2024 Page: Website outages and upgradesUpdated
03/07/2024 Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathiesUpdated
03/07/2024 Document: Clinical Trial Information System (CTIS) - Sponsor handbookUpdated
03/07/2024 Medicine: XevudyUpdated
03/07/2024 Page: Big dataUpdated
03/07/2024 Page: International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)Updated
02/07/2024 Medicine: Imatinib AccordUpdated
02/07/2024 Medicine: Emtricitabine/Tenofovir disoproxil Krka d.d.Updated
02/07/2024 Medicine: EvusheldUpdated
02/07/2024 Medicine: Memantine MylanUpdated
02/07/2024 Medicine: KeytrudaUpdated
02/07/2024 Medicine: Duloxetine ZentivaUpdated
02/07/2024 Medicine: OpdivoUpdated
02/07/2024 Medicine: Lenalidomide AccordUpdated
02/07/2024 Medicine: JakaviUpdated
02/07/2024 Medicine: OzurdexUpdated
02/07/2024 Medicine: TavneosUpdated
02/07/2024 Medicine: FilspariUpdated
02/07/2024 Document: European Medicines Agency's data protection notice for the HMA-EMA Catalogue of real-world data sources (and networks and institutions)Updated
02/07/2024 Medicine: IbranceUpdated
02/07/2024 Medicine: LyricaUpdated
02/07/2024 Page: Union Product DatabaseUpdated
02/07/2024 Event: Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methodsUpdated
02/07/2024 Document: European Medicines Agency’s data protection notice for the HMA-EMA Catalogue of real-world data studiesUpdated
02/07/2024 Medicine: RetsevmoUpdated
02/07/2024 Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024Updated
02/07/2024 Page: Union Product Database: release notesUpdated
02/07/2024 Document: Release notes - production release version 1.7.2424-5 July 2024 - Veterinary Medical Products Regulation: Union Product DatabaseNew
02/07/2024 Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7Updated
01/07/2024 Document: Agenda - Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonistsUpdated
01/07/2024 Document: Organisation chart: Advisory functionsUpdated
01/07/2024 Page: Concept paper on the revision of the COVID-19 vaccines guidance documentsNew
01/07/2024 Page: World Health Organization (WHO)Updated
01/07/2024 Medicine: AgilusUpdated
01/07/2024 Document: Mysimba Article-20 procedure - Timetable for the procedureUpdated
01/07/2024 Medicine: Pregabalin PfizerUpdated
01/07/2024 Medicine: Capecitabine AccordUpdated
01/07/2024 Document: Annual accounts: Financial year 2023New
01/07/2024 Page: SME Regulation and reportsUpdated
01/07/2024 Medicine: IlumetriUpdated
01/07/2024 Page: Clinical investigation of medicinal products for the treatment of psoriatic arthritis - Scientific guidelineUpdated
01/07/2024 Document: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritisNew
01/07/2024 Document: Policy 1: Quality Management PolicyUpdated