| 13/06/2025 | PIP: EMEA-003451-PIP01-23 - paediatric investigation plan | New |
| 13/06/2025 | News: EMA Management Board: highlights of June 2025 meeting | New |
| 13/06/2025 | Referral: Veterinary medicinal products containing albendazole as a single active substance presented as oral suspension in sheep - referral | New |
| 13/06/2025 | PSUSA: PSUSA/00001331/202409 - periodic safety update report single assessment | New |
| 13/06/2025 | PIP: EMEA-002963-PIP01-21-M01 - paediatric investigation plan | Updated |
| 13/06/2025 | News: First vaccine against swine dysentery disease recommended for approval | New |
| 13/06/2025 | Medicine: Rivastigmine Actavis | Updated |
| 13/06/2025 | Medicine: Ahzantive | Updated |
| 13/06/2025 | Medicine: Baiama | Updated |
| 13/06/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 June 2025 | New |
| 13/06/2025 | Post-authorisation: Nobivac L4 - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Post-authorisation: NexGard - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Post-authorisation: Nexgard Spectra - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Post-authorisation: Nobivac LoVo L4 - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Post-authorisation: Poulvac E. coli - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Post-authorisation: Daxocox - opinion on variation to marketing authorisation | New |
| 13/06/2025 | Medicine: Biobhyo | New |
| 13/06/2025 | Medicine: Bravecto CombiUNO | New |
| 13/06/2025 | Medicine: Zenrelia | New |
| 13/06/2025 | Medicine: Humira | Updated |
| 13/06/2025 | News: PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy | Updated |
| 13/06/2025 | Medicine: Viread | Updated |
| 13/06/2025 | Medicine: Invokana | Updated |
| 13/06/2025 | PIP: EMEA-002168-PIP01-17-M06 - paediatric investigation plan | Updated |
| 12/06/2025 | PIP: EMEA-001930-PIP01-16-M05 - paediatric investigation plan | Updated |
| 12/06/2025 | PIP: EMEA-002999-PIP01-21-M01 - paediatric investigation plan | Updated |
| 12/06/2025 | PSUSA: PSUSA/00010067/202410 - periodic safety update report single assessment | New |
| 12/06/2025 | PIP: EMEA-002269-PIP01-17-M03 - paediatric investigation plan | Updated |
| 12/06/2025 | Medicine: Amvuttra | Updated |
| 12/06/2025 | PIP: EMEA-001407-PIP02-15-M07 - paediatric investigation plan | Updated |
| 12/06/2025 | Medicine: Sugammadex Piramal | Updated |
| 12/06/2025 | Medicine: Rybrevant | Updated |
| 12/06/2025 | Medicine: Zerbaxa | Updated |
| 12/06/2025 | PIP: EMEA-001136-PIP01-11-M03 - paediatric investigation plan | Updated |
| 12/06/2025 | Document: Presentation - The summary-of-product-characteristics guideline and paediatric aspects | Updated |
| 12/06/2025 | Medicine: Steqeyma | Updated |
| 12/06/2025 | Event: Eighth European Medicines Agency (EMA) and EFPIA bilateral meeting | New |
| 12/06/2025 | PIP: EMEA-001619-PIP04-17-M03 - paediatric investigation plan | Updated |
| 12/06/2025 | PIP: EMEA-001260-PIP01-11-M03 - paediatric investigation plan | Updated |
| 12/06/2025 | Document: Agenda - Management Board meeting: 11-12 June 2025 | Updated |
| 12/06/2025 | Medicine: Nyxoid | Updated |
| 12/06/2025 | Document: CTIS newsflash - 10 June 2025 | New |
| 12/06/2025 | Medicine: Crysvita | Updated |
| 12/06/2025 | Page: EudraVigilance training and support | Updated |
| 12/06/2025 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 12/06/2025 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 12/06/2025 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 12/06/2025 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 12/06/2025 | Document: CHMP-CAT - D80-210 Overview to final EPAR - Rev 06.25 Revamp | Updated |
| 12/06/2025 | Document: List of metadata for the HMA-EMA Catalogues of real-world data sources and studies | Updated |
| 12/06/2025 | Document: User guide of the HMA-EMA Catalogues of real-world data sources and studies | Updated |
| 12/06/2025 | Document: Agenda - Workshop on the use of Bayesian statistics in clinical development | Updated |
| 12/06/2025 | Page: Medicines for human use under evaluation | Updated |
| 12/06/2025 | Shortage: Perfusion solutions | New |
| 11/06/2025 | Medicine: Columvi | Updated |
| 11/06/2025 | Medicine: Leflunomide Zentiva (previously Leflunomide Winthrop) | Updated |
| 11/06/2025 | PIP: EMEA-001220-PIP01-11-M10 - paediatric investigation plan | Updated |
| 11/06/2025 | PIP: EMEA-002362-PIP02-19-M03 - paediatric investigation plan | Updated |
| 11/06/2025 | PIP: EMEA-001823-PIP01-15-M03 - paediatric investigation plan | Updated |
| 11/06/2025 | PSUSA: PSUSA/00001989/202408 - periodic safety update report single assessment | New |
| 11/06/2025 | PSUSA: PSUSA/00001455/202410 - periodic safety update report single assessment | New |
| 11/06/2025 | PIP: EMEA-002780-PIP02-20-M01 - paediatric investigation plan | Updated |
| 11/06/2025 | PSUSA: PSUSA/00010386/202410 - periodic safety update report single assessment | New |
| 11/06/2025 | PIP: EMEA-002486-PIP04-21-M01 - paediatric investigation plan | Updated |
| 11/06/2025 | Medicine: MenQuadfi | Updated |
| 11/06/2025 | Medicine: Bimervax | Updated |
| 11/06/2025 | PIP: EMEA-000813-PIP01-09-M01 - paediatric investigation plan | Updated |
| 11/06/2025 | Medicine: Dexdor | Updated |
| 11/06/2025 | PIP: EMEA-000183-PIP02-12-M05 - paediatric investigation plan | Updated |
| 11/06/2025 | PIP: EMEA-003624-PIP01-24 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003623-PIP01-24 - paediatric investigation plan | New |
| 11/06/2025 | Medicine: Sugammadex Mylan | Updated |
| 11/06/2025 | PIP: EMEA-003573-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003570-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003567-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003448-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-002597-PIP10-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003566-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-000520-PIP03-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003546-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003563-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | Medicine: Skyrizi | Updated |
| 11/06/2025 | PIP: EMEA-003390-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | Medicine: Absimky | Updated |
| 11/06/2025 | PIP: EMEA-003562-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003561-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003559-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003557-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003555-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003554-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003552-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003534-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003530-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | Event: 14th industry stakeholder platform on research and development support | New |
| 11/06/2025 | Medicine: Zostavax | Updated |
| 11/06/2025 | PIP: EMEA-003485-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003481-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003478-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003465-PIP01-23 - paediatric investigation plan | New |
| 11/06/2025 | Medicine: Numelvi | New |
| 10/06/2025 | PIP: EMEA-002958-PIP01-21-M01 - paediatric investigation plan | Updated |
| 10/06/2025 | PIP: EMEA-001585-PIP01-13-M06 - paediatric investigation plan | Updated |
| 10/06/2025 | PIP: EMEA-002208-PIP01-17-M04 - paediatric investigation plan | Updated |
| 10/06/2025 | PIP: EMEA-003071-PIP01-21-M01 - paediatric investigation plan | Updated |
| 10/06/2025 | PIP: EMEA-003453-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Imuldosa | Updated |
| 10/06/2025 | PIP: EMEA-001198-PIP04-23 - paediatric investigation plan | New |
| 10/06/2025 | PSUSA: PSUSA/00010988/202410 - periodic safety update report single assessment | New |
| 10/06/2025 | PIP: EMEA-003439-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Rozlytrek | Updated |
| 10/06/2025 | Medicine: Rinvoq | Updated |
| 10/06/2025 | PIP: EMEA-002208-PIP02-24 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003543-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Vokanamet | Updated |
| 10/06/2025 | PIP: EMEA-003542-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Capvaxive | Updated |
| 10/06/2025 | PIP: EMEA-003443-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003551-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Zirabev | Updated |
| 10/06/2025 | Medicine: Apexelsin | Updated |
| 10/06/2025 | PIP: EMEA-003457-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | Document: Minutes of the COMP meeting 14-15 April 2025 | New |
| 10/06/2025 | Document: QRD Appendix V - Adverse-drug-reaction reporting details | Updated |
| 10/06/2025 | PIP: EMEA-003395-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003454-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003248-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003434-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-002883-PIP03-23 - paediatric investigation plan | New |
| 10/06/2025 | Page: Annual reports and work programmes | Updated |
| 10/06/2025 | Document: Annexes - 2024 annual report of the European Medicines Agency | New |
| 10/06/2025 | Document: Annex 10 - 2024 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication | New |
| 10/06/2025 | Document: 2024 annual report of the European Medicines Agency | New |
| 10/06/2025 | Medicine: Jyseleca | Updated |
| 10/06/2025 | PIP: EMEA-003393-PIP01-23 - paediatric investigation plan | New |
| 10/06/2025 | News: 2024 annual report is published | New |
| 10/06/2025 | PIP: EMEA-003333-PIP01-22 - paediatric investigation plan | New |
| 10/06/2025 | PIP: EMEA-003299-PIP01-22 - paediatric investigation plan | New |
| 10/06/2025 | Medicine: Qoyvolma | Updated |
| 10/06/2025 | PIP: EMEA-003277-PIP02-23 - paediatric investigation plan | New |
| 10/06/2025 | Event: Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs | New |
| 10/06/2025 | Document: Network Portfolio Roadmap | Updated |
| 10/06/2025 | Event: 1st EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection | New |
| 10/06/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities | Updated |
| 10/06/2025 | Document: Quality control of medicinal product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No. 726/2004 | Updated |
| 10/06/2025 | Document: Day 80 assessment report - Non-clinical template with guidance - Rev 06.25 Revamp | Updated |
| 10/06/2025 | Document: Agenda of the COMP meeting 10-12 June 2025 | New |
| 10/06/2025 | Document: Agenda of the CVMP meeting 10-12 June 2025 | New |
| 10/06/2025 | Orphan: EU/3/18/2012 - orphan designation for treatment of epidermolysis bullosa | Updated |
| 10/06/2025 | Orphan: EU/3/22/2736 - orphan designation for treatment of ornithine transcarbamylase deficiency | Updated |
| 10/06/2025 | Orphan: EU/3/19/2140 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's syndrome) | Updated |
| 10/06/2025 | Orphan: EU/3/20/2379 - orphan designation for treatment of Angelman syndrome | Updated |
| 10/06/2025 | Orphan: EU/3/21/2498 - orphan designation for treatment of frontotemporal dementia | Updated |
| 10/06/2025 | Orphan: EU/3/17/1922 - orphan designation for treatment of acute myeloid leukaemia | Updated |
| 10/06/2025 | Orphan: EU/3/21/2462 - orphan designation for treatment of propionic acidaemia | Updated |
| 10/06/2025 | Orphan: EU/3/21/2461 - orphan designation for treatment of pantothenate kinase-associated neurodegeneration | Updated |
| 10/06/2025 | Orphan: EU/3/24/2931 - orphan designation for treatment of idiopathic pulmonary fibrosis | Updated |
| 10/06/2025 | Orphan: EU/3/21/2425 - orphan designation for treatment of cutaneous T-cell lymphoma | Updated |
| 10/06/2025 | Orphan: EU/3/20/2267 - orphan designation for treatment of progressive familial intrahepatic cholestasis | Updated |
| 10/06/2025 | Orphan: EU/3/25/3045 - orphan designation for prevention of fetal and neonatal alloimmune thrombocytopenia | New |
| 10/06/2025 | Orphan: EU/3/25/3051 - orphan designation for treatment of familial adenomatous polyposis (FAP) | New |
| 10/06/2025 | Orphan: EU/3/25/3052 - orphan designation for treatment of primary ubiquinone deficiency | New |
| 10/06/2025 | Orphan: EU/3/25/3048 - orphan designation for treatment of primary IgA nephropathy | New |
| 10/06/2025 | Orphan: EU/3/25/3047 - orphan designation for treatment of Duchenne muscular dystrophy | New |
| 06/06/2025 | PIP: EMEA-002924-PIP02-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002727-PIP03-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002573-PIP02-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002490-PIP01-18 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002475-PIP04-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002341-PIP02-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002042-PIP03-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-001039-PIP04-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002861-PIP02-20-M07 - paediatric investigation plan | Updated |
| 06/06/2025 | PIP: EMEA-002746-PIP01-20-M03 - paediatric investigation plan | Updated |
| 06/06/2025 | PIP: EMEA-002736-PIP02-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-002618-PIP02-20-M01 - paediatric investigation plan | Updated |
| 06/06/2025 | PIP: EMEA-003569-PIP01-23 - paediatric investigation plan | New |
| 06/06/2025 | Medicine: Bylvay | Updated |
| 06/06/2025 | PIP: EMEA-003405-PIP01-23 - paediatric investigation plan | New |
| 06/06/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025 | New |
| 06/06/2025 | PSUSA: PSUSA/00001842/202410 - periodic safety update report single assessment | New |
| 06/06/2025 | Medicine: Epruvy (previously Ranibizumab Midas) | Updated |
| 06/06/2025 | Medicine: Ranivisio | Updated |
| 06/06/2025 | PIP: EMEA-003313-PIP03-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-003540-PIP01-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-003537-PIP01-23 - paediatric investigation plan | New |
| 06/06/2025 | PIP: EMEA-003528-PIP01-23 - paediatric investigation plan | New |
| 06/06/2025 | Medicine: Eydenzelt | Updated |
| 06/06/2025 | Event: Quarterly System Demo - Q2 2025 | Updated |
| 06/06/2025 | PIP: EMEA-002016-PIP05-23 - paediatric investigation plan | New |
| 06/06/2025 | Medicine: Zyprexa | Updated |
| 06/06/2025 | Medicine: HBVaxPro | Updated |
| 06/06/2025 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products | Updated |
| 06/06/2025 | Document: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) annual activity report 2024 | New |
| 06/06/2025 | Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services | Updated |
| 05/06/2025 | PIP: EMEA-002600-PIP01-19-M02 - paediatric investigation plan | Updated |
| 05/06/2025 | PIP: EMEA-002418-PIP01-18-M03 - paediatric investigation plan | Updated |
| 05/06/2025 | PIP: EMEA-003220-PIP01-22-M01 - paediatric investigation plan | Updated |
| 05/06/2025 | PIP: EMEA-003215-PIP01-22-M01 - paediatric investigation plan | Updated |
| 05/06/2025 | Shortage: NovoSeven (eptacog alfa) | Updated |
| 05/06/2025 | PSUSA: PSUSA/00000795/202410 - periodic safety update report single assessment | New |
| 05/06/2025 | Document: Highlights - Second EMA / Alliance for Regenerative Medicine bilateral meeting | New |
| 05/06/2025 | Orphan: EU/3/04/211 - orphan designation for prevention of hepatic veno-occlusive disease | Updated |
| 05/06/2025 | Orphan: EU/3/13/1201 - orphan designation for prevention of graft-versus-host disease | Updated |
| 05/06/2025 | Orphan: EU/3/19/2224 - orphan designation for treatment of CDKL5 deficiency disorder | Updated |
| 05/06/2025 | Orphan: EU/3/21/2419 - orphan designation for treatment of ATTR amyloidosis | Updated |
| 05/06/2025 | Orphan: EU/3/22/2727 - orphan designation for diagnosis of neuroendocrine neoplasms | Updated |
| 05/06/2025 | Orphan: EU/3/21/2503 - orphan designation for treatment of tuberous sclerosis | Updated |
| 05/06/2025 | Orphan: EU/3/11/930 - orphan designation for treatment of Hodgkin's lymphoma | Updated |
| 05/06/2025 | Orphan: EU/3/17/1928 - orphan designation for treatment of Leber's congenital amaurosis | Updated |
| 05/06/2025 | Orphan: EU/3/11/913 - orphan designation for treatment of hepatocellular carcinoma | Updated |
| 05/06/2025 | Orphan: EU/3/22/2664 - orphan designation for treatment of epidermolysis bullosa | Updated |
| 05/06/2025 | Orphan: EU/3/21/2560 - orphan designation for treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) | Updated |
| 05/06/2025 | Orphan: EU/3/21/2405 - orphan designation for treatment of gastric cancer | Updated |
| 05/06/2025 | Orphan: EU/3/25/3050 - orphan designation for treatment of pre-eclampsia | New |
| 05/06/2025 | Orphan: EU/3/25/3049 - orphan designation for treatment of spinal muscular atrophy | New |
| 05/06/2025 | Orphan: EU/3/25/3046 - orphan designation for treatment of non-infectious uveitis | New |
| 05/06/2025 | PSUSA: PSUSA/00000051/202410 - periodic safety update report single assessment | New |
| 05/06/2025 | Event: EU Medicines Assessment - Opportunities for expert involvement | New |
| 05/06/2025 | News: EMA closed 9 June | New |
| 05/06/2025 | Medicine: Tigecycline Accord | Updated |
| 05/06/2025 | Event: EMA/FVE info session for veterinary practitioners : Understanding the first report of sales and use of antimicrobials in animals | Updated |
| 05/06/2025 | Document: QRD veterinary product-information highlighted template version 9.1 | Updated |
| 05/06/2025 | Document: QRD veterinary product-information template version 9.1 | Updated |
| 05/06/2025 | Document: QRD veterinary combined label-leaflet template v.9.1 | Updated |
| 05/06/2025 | Document: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations | Updated |
| 05/06/2025 | Document: Minutes - PDCO minutes of the 22-25 April 2025 meeting | New |
| 05/06/2025 | Document: Minutes of the CHMP meeting 27-30 January 2025 | Updated |
| 05/06/2025 | Event: HMA/EMA multi-stakeholder workshop on artificial intelligence | New |
| 05/06/2025 | Shortage: Pegasys | Updated |
| 05/06/2025 | PIP: EMEA-003394-PIP01-23 - paediatric investigation plan | New |
| 05/06/2025 | Medicine: Efmody | Updated |
| 05/06/2025 | Medicine: Ztalmy | Updated |
| 04/06/2025 | Medicine: Pelgraz Paediatric | Updated |
| 04/06/2025 | PSUSA: PSUSA/00010855/202408 - periodic safety update report single assessment | New |
| 04/06/2025 | Medicine: Rivaroxaban Viatris (previously Rivaroxaban Mylan) | Updated |
| 04/06/2025 | Medicine: Spexotras | Updated |
| 04/06/2025 | Medicine: Finlee | Updated |
| 04/06/2025 | Page: CHMP opinions on consultation procedures | Updated |
| 04/06/2025 | Document: IVF Media G5 - Procedural steps and scientific information after initial consultation | New |
| 04/06/2025 | Document: IVF Media G5 - Procedural steps and scientific information after initial consultation (archive) | Updated |
| 04/06/2025 | Medicine: Beqvez (previously Durveqtix) | Updated |
| 04/06/2025 | Medicine: Roclanda | Updated |
| 04/06/2025 | Document: Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) | Updated |
| 04/06/2025 | Page: Medicines during pregnancy and breastfeeding | New |
| 04/06/2025 | Medicine: Tecvayli | Updated |
| 04/06/2025 | Document: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2 | Updated |
| 04/06/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 April 2025 | Updated |
| 04/06/2025 | Document: Minutes of the PRAC meeting 07-10 April 2025 | New |
| 04/06/2025 | Event: EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation | Updated |
| 04/06/2025 | Medicine: Remicade | Updated |
| 04/06/2025 | Event: Public webinar on shortages: putting patients first | New |
| 04/06/2025 | Medicine: Veklury | Updated |
| 04/06/2025 | Document: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials | New |
| 04/06/2025 | News: New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials | New |
| 03/06/2025 | Medicine: Ibrance | Updated |
| 03/06/2025 | Referral: Ixchiq - referral | Updated |
| 03/06/2025 | Page: Patients and consumers | Updated |
| 03/06/2025 | Medicine: Atropine sulfate FGK | Updated |
| 03/06/2025 | Medicine: Mysimba | Updated |
| 03/06/2025 | Referral: Mysimba - referral | Updated |
| 03/06/2025 | Document: Questions and answers on the refusal of the marketing authorisation for Atropine sulfate FGK (atropine sulfate) | Updated |
| 03/06/2025 | Medicine: Zeffix | Updated |
| 03/06/2025 | Event: 13th Industry Standing Group (ISG) meeting | New |
| 03/06/2025 | Event: Clinical Trials Information System (CTIS): Information day | Updated |
| 03/06/2025 | Page: Quality of medicines questions and answers: Part 2 | Updated |
| 03/06/2025 | Medicine: Cholestagel | Updated |
| 03/06/2025 | Document: European Medicines Agency decision CW/0001/2025 of 2 June 2025 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council | New |
| 03/06/2025 | Page: Class waivers | Updated |
| 03/06/2025 | Document: EMA/PDCO summary report on the review of the list of granted Class Waivers 2 June 2025 | New |
| 03/06/2025 | Medicine: Imcivree | Updated |
| 03/06/2025 | Document: Superseded - EMA/PDCO Summary Report on the review of the list of granted Class Waivers | Updated |
| 03/06/2025 | Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs) | Updated |
| 03/06/2025 | Page: World Health Organization (WHO) | Updated |
| 03/06/2025 | Medicine: Leqembi | Updated |
| 03/06/2025 | Medicine: Atazanavir Krka | Updated |
| 02/06/2025 | Medicine: Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) | Updated |
| 02/06/2025 | Medicine: Abrysvo | Updated |
| 02/06/2025 | Medicine: Tevimbra | Updated |
| 02/06/2025 | Medicine: Tecartus | Updated |
| 02/06/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 2 - 5 June 2025 | Updated |
| 02/06/2025 | Document: Faecal microbiota transplantation EU-IN Horizon Scanning Report | Updated |
| 02/06/2025 | Document: Agenda of the PRAC meeting 2-5 June 2025 | New |
| 02/06/2025 | Event: Workshop on the use of Bayesian statistics in clinical development | Updated |
| 02/06/2025 | Document: CAT quarterly highlights and approved ATMPs - May 2025 | New |
| 02/06/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 02/06/2025 | Page: Plasma master file certificates | Updated |
| 02/06/2025 | Document: Organisation chart: Advisory functions | Updated |
| 02/06/2025 | Document: Meeting summary - Medicine shortages (SPOC) working party 10-11 April 2025 | New |
| 02/06/2025 | Medicine: Camzyos | Updated |
| 02/06/2025 | Medicine: Opdivo | Updated |
| 02/06/2025 | Document: Applicant / marketing authorisation holder change of contact person for product invented name / product number template | Updated |
| 02/06/2025 | Medicine: Takhzyro | Updated |
| 02/06/2025 | Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) | Updated |
| 02/06/2025 | Medicine: Xofluza | Updated |
| 02/06/2025 | Page: PRIME: priority medicines | Updated |
| 02/06/2025 | Document: List of medicines currently in PRIME scheme | Updated |
| 02/06/2025 | Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 May 2025 | New |
| 02/06/2025 | Medicine: Upstaza | Updated |
| 02/06/2025 | Medicine: Wezenla | Updated |
| 02/06/2025 | Page: Scientific and technical recommendations: Veterinary Medicines Regulation | Updated |
| 02/06/2025 | Medicine: Hepizovac | Updated |
| 02/06/2025 | Medicine: Prazivetin | Updated |
| 02/06/2025 | Medicine: Prevestrus vet | Updated |
| 02/06/2025 | Medicine: Nobilis Multriva IBm+ND+EDS | Updated |
| 02/06/2025 | Medicine: Prasugrel Viatris (previously Prasugrel Mylan) | Updated |
| 02/06/2025 | Medicine: Temozolomide Accord | Updated |
| 02/06/2025 | Medicine: Rheumocam | Updated |
| 02/06/2025 | Event: Product Management Service (PMS) information day 2025 | Updated |
| 02/06/2025 | Page: PRAC recommendations on safety signals | Updated |
| 02/06/2025 | Document: List of signals discussed at PRAC since September 2012 | Updated |
| 02/06/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 May 2025 PRAC | New |
| 02/06/2025 | Document: PRAC recommendations on signals adopted at the 5-8 May 2025 meeting | New |
| 02/06/2025 | Medicine: Trumenba | Updated |
| 02/06/2025 | Page: Guidance documents | Updated |
| 02/06/2025 | Document: Overview of comments received on 'Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations' (EMA/CVMP/55240/2025) | New |
| 02/06/2025 | Document: Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations | New |
| 02/06/2025 | Page: Advisory functions | Updated |
| 02/06/2025 | Herbal: Ononidis radix - herbal medicinal product | Updated |
| 02/06/2025 | Document: Draft European Union herbal monograph on Ononis spinosa L., radix - Revision 1 | New |
| 02/06/2025 | Medicine: Verzenios | Updated |
| 02/06/2025 | PSUSA: PSUSA/00000082/202409 - periodic safety update report single assessment | New |
| 02/06/2025 | PSUSA: PSUSA/00002235/202408 - periodic safety update report single assessment | New |
| 02/06/2025 | Document: Process for the electronic submission of medicinal product information - Chapter 3 | Updated |
| 02/06/2025 | Document: Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents | New |
