| 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 | News: PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy | 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 | 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 combined label-leaflet template v.9.1 | 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: 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: Agenda - Workshop on the use of Bayesian statistics in clinical development | 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: Mysimba | Updated |
| 03/06/2025 | Medicine: Atropine sulfate FGK | 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 |
