05/07/2024 | Medicine: Obgemsa | Updated |
05/07/2024 | PIP: EMEA-000380-PIP10-23 - paediatric investigation plan | New |
05/07/2024 | PIP: EMEA-002961-PIP01-21-M02 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-002899-PIP01-20-M02 - paediatric investigation plan | Updated |
05/07/2024 | Medicine: Olumiant | Updated |
05/07/2024 | Medicine: Mektovi | Updated |
05/07/2024 | PIP: EMEA-002762-PIP02-20-M01 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-002735-PIP03-20-M02 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-002735-PIP01-19-M01 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-002563-PIP02-19-M02 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-002229-PIP02-21-M01 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001900-PIP02-17-M07 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001766-PIP01-15-M05 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001741-PIP01-14-M06 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001627-PIP01-14-M03 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001299-PIP03-17-M02 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001220-PIP01-11-M08 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001150-PIP02-13-M05 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-001089-PIP02-13-M04 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000902-PIP01-10-M01 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000798-PIP01-09-M04 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000551-PIP04-21-M02 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000468-PIP02-12-M08 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000347-PIP02-16-M05 - paediatric investigation plan | Updated |
05/07/2024 | PIP: EMEA-000207-PIP01-08-M08 - paediatric investigation plan | Updated |
05/07/2024 | Referral: Hydroxyprogesterone caproate-containing medicinal products - referral | Updated |
05/07/2024 | Medicine: Dovprela (previously Pretomanid FGK) | Updated |
05/07/2024 | Medicine: Comirnaty | Updated |
05/07/2024 | Document: 2023 annual report of the European Medicines Agency | Updated |
05/07/2024 | Page: Pharmacovigilance fees payable to the European Medicines Agency | Updated |
05/07/2024 | PSUSA: PSUSA/00000059/202309 - periodic safety update report single assessment | Updated |
05/07/2024 | PSUSA: PSUSA/00010342/202309 - periodic safety update report single assessment | Updated |
05/07/2024 | Medicine: Mounjaro | Updated |
05/07/2024 | Page: Fees payable to the European Medicines Agency | Updated |
05/07/2024 | Document: New Fee Regulation working arrangements | New |
05/07/2024 | Medicine: Zometa | Updated |
05/07/2024 | Document: Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2 | New |
05/07/2024 | Medicine: Baraclude | Updated |
04/07/2024 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
04/07/2024 | Medicine: Leqvio | Updated |
04/07/2024 | Medicine: Tecentriq | Updated |
04/07/2024 | Medicine: Sotyktu | Updated |
04/07/2024 | Medicine: Esperoct | Updated |
04/07/2024 | Medicine: Grasustek | Updated |
04/07/2024 | PIP: EMEA-003149-PIP01-21-M01 - paediatric investigation plan | Updated |
04/07/2024 | PIP: EMEA-003001-PIP01-21-M01 - paediatric investigation plan | Updated |
04/07/2024 | PIP: EMEA-002942-PIP02-20-M01 - paediatric investigation plan | Updated |
04/07/2024 | PIP: EMEA-002935-PIP01-20-M03 - paediatric investigation plan | Updated |
04/07/2024 | Medicine: Abilify Maintena | Updated |
04/07/2024 | Medicine: Abiraterone Accord | Updated |
04/07/2024 | PIP: EMEA-002443-PIP01-18-M02 - paediatric investigation plan | Updated |
04/07/2024 | PIP: EMEA-002705-PIP01-19-M01 - paediatric investigation plan | Updated |
04/07/2024 | PIP: EMEA-002597-PIP05-21-M01 - paediatric investigation plan | Updated |
04/07/2024 | Medicine: Spinraza | Updated |
04/07/2024 | Medicine: Buccolam | Updated |
04/07/2024 | News: Recent additions to EMA’s management team | New |
04/07/2024 | Medicine: Ultomiris | Updated |
04/07/2024 | Page: Advisory functions | Updated |
04/07/2024 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
04/07/2024 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
04/07/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Krka | Updated |
03/07/2024 | Medicine: Orkambi | Updated |
03/07/2024 | Medicine: Rozlytrek | Updated |
03/07/2024 | Medicine: Camzyos | Updated |
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 upgrades | Updated |
03/07/2024 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies | Updated |
03/07/2024 | Document: Clinical Trial Information System (CTIS) - Sponsor handbook | Updated |
03/07/2024 | Medicine: Xevudy | Updated |
03/07/2024 | Page: Big data | Updated |
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 Accord | Updated |
02/07/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Krka d.d. | Updated |
02/07/2024 | Medicine: Evusheld | Updated |
02/07/2024 | Medicine: Memantine Mylan | Updated |
02/07/2024 | Medicine: Keytruda | Updated |
02/07/2024 | Medicine: Duloxetine Zentiva | Updated |
02/07/2024 | Medicine: Opdivo | Updated |
02/07/2024 | Medicine: Lenalidomide Accord | Updated |
02/07/2024 | Medicine: Jakavi | Updated |
02/07/2024 | Medicine: Ozurdex | Updated |
02/07/2024 | Medicine: Tavneos | Updated |
02/07/2024 | Medicine: Filspari | Updated |
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: Ibrance | Updated |
02/07/2024 | Medicine: Lyrica | Updated |
02/07/2024 | Page: Union Product Database | Updated |
02/07/2024 | Event: Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
02/07/2024 | Document: European Medicines Agency’s data protection notice for the HMA-EMA Catalogue of real-world data studies | Updated |
02/07/2024 | Medicine: Retsevmo | Updated |
02/07/2024 | Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024 | Updated |
02/07/2024 | Page: Union Product Database: release notes | Updated |
02/07/2024 | Document: Release notes - production release version 1.7.2424-5 July 2024 - Veterinary Medical Products Regulation: Union Product Database | New |
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 7 | Updated |
01/07/2024 | Document: Agenda - Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists | Updated |
01/07/2024 | Document: Organisation chart: Advisory functions | Updated |
01/07/2024 | Page: Concept paper on the revision of the COVID-19 vaccines guidance documents | New |
01/07/2024 | Page: World Health Organization (WHO) | Updated |
01/07/2024 | Medicine: Agilus | Updated |
01/07/2024 | Document: Mysimba Article-20 procedure - Timetable for the procedure | Updated |
01/07/2024 | Medicine: Pregabalin Pfizer | Updated |
01/07/2024 | Medicine: Capecitabine Accord | Updated |
01/07/2024 | Document: Annual accounts: Financial year 2023 | New |
01/07/2024 | Page: SME Regulation and reports | Updated |
01/07/2024 | Medicine: Ilumetri | Updated |
01/07/2024 | Page: Clinical investigation of medicinal products for the treatment of psoriatic arthritis - Scientific guideline | Updated |
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 arthritis | New |
01/07/2024 | Document: Policy 1: Quality Management Policy | Updated |