| 30/06/2025 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
| 30/06/2025 | Page: Transparency: exceptional measures for COVID-19 medicines | Updated |
| 30/06/2025 | Medicine: Jardiance | Updated |
| 30/06/2025 | Orphan: EU/3/25/3060 - orphan designation for treatment of gastric cancer | New |
| 30/06/2025 | Medicine: BroPair Spiromax | Updated |
| 30/06/2025 | Medicine: Levetiracetam Actavis | Updated |
| 30/06/2025 | Orphan: EU/3/25/3054 - orphan designation for treatment of idiopathic pulmonary fibrosis | New |
| 30/06/2025 | Medicine: Glyxambi | Updated |
| 30/06/2025 | Medicine: Keppra | Updated |
| 30/06/2025 | Orphan: EU/3/25/3059 - orphan designation for treatment of acute myeloid leukaemia | New |
| 30/06/2025 | Page: Guidance on the application of the revised variations framework | Updated |
| 30/06/2025 | Page: Ursodeoxycholic acid product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Prasugrel product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: About this website | Updated |
| 30/06/2025 | Page: Paracetamol product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Oseltamivir product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Metformin product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Accessibility | New |
| 30/06/2025 | Page: Dabigatran etexilate product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Medicine: Levetiracetam ratiopharm | Updated |
| 30/06/2025 | Document: Annual activity report 2024 | New |
| 30/06/2025 | Page: Real-world evidence | Updated |
| 30/06/2025 | Page: Memantine product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Orphan: EU/3/25/3063 - orphan designation for treatment of Becker muscular dystrophy | New |
| 30/06/2025 | Page: Posaconazole product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Document: Infosheet: EMA review of real-world data studies from September 2021 to February 2025 | New |
| 30/06/2025 | Document: Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025 | New |
| 30/06/2025 | Medicine: Levetiracetam Teva | Updated |
| 30/06/2025 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - September 2025 | New |
| 30/06/2025 | Page: Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects | New |
| 30/06/2025 | Page: ICH E20 adaptive designs for clinical trials - Scientific guideline | New |
| 30/06/2025 | Document: ICH E20 guideline on adaptive designs for clinical trials - Step 2b | New |
| 30/06/2025 | Orphan: EU/3/09/645 - orphan designation for treatment of acromegaly | Updated |
| 30/06/2025 | Orphan: EU/3/13/1117 - orphan designation for treatment of Stargardt's disease | Updated |
| 30/06/2025 | Orphan: EU/3/22/2607 - orphan designation for treatment of Fabry disease | Updated |
| 30/06/2025 | Orphan: EU/3/19/2203 - orphan designation for treatment of Netherton syndrome | Updated |
| 30/06/2025 | Page: Lurasidone product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Document: List of centrally authorised products with safety-related changes to the product information | Updated |
| 30/06/2025 | Page: Apixaban product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Acenocoumarol product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Voriconazole product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Periodic safety update reports (PSURs) | Updated |
| 30/06/2025 | Page: Tadalafil product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Page: Repaglinide product-specific bioequivalence guidance | Updated |
| 30/06/2025 | Document: Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9 | Updated |
| 30/06/2025 | Medicine: Emtricitabine/Tenofovir disoproxil Mylan | Updated |
| 30/06/2025 | Event: Quarterly System Demo - Q2 2025 | Updated |
| 30/06/2025 | Page: PRAC recommendations on safety signals | Updated |
| 30/06/2025 | Document: List of signals discussed at PRAC since September 2012 | Updated |
| 30/06/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC | New |
| 30/06/2025 | Document: PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting | New |
| 30/06/2025 | Page: Requesting scientific advice or protocol assistance from EMA | Updated |
| 30/06/2025 | Medicine: Levetiracetam Actavis Group | Updated |
| 30/06/2025 | Medicine: Vyjuvek | Updated |
| 30/06/2025 | Medicine: Xenpozyme | Updated |
| 27/06/2025 | Medicine: Xelevia | Updated |
| 27/06/2025 | Medicine: Tesavel | Updated |
| 27/06/2025 | Medicine: Ristaben | Updated |
| 27/06/2025 | Medicine: Avamys | Updated |
| 27/06/2025 | Post-authorisation: Lutathera - withdrawal of application for variation to marketing authorisation | Updated |
| 27/06/2025 | Medicine: Eylea | Updated |
| 27/06/2025 | Medicine: Tresiba | Updated |
| 27/06/2025 | Medicine: Saxenda | Updated |
| 27/06/2025 | Medicine: Zoonotic Influenza Vaccine Seqirus | Updated |
| 27/06/2025 | Event: Second EMA and European Society of Cardiology (ESC) bilateral meeting | Updated |
| 27/06/2025 | Document: List of medicines currently in PRIME scheme | Updated |
| 27/06/2025 | Document: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms | Updated |
| 27/06/2025 | Document: Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes | Updated |
| 27/06/2025 | Document: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025 | Updated |
| 27/06/2025 | Document: Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products | Updated |
| 27/06/2025 | Document: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet) | Updated |
| 27/06/2025 | Document: Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list | Updated |
| 27/06/2025 | Medicine: Revolade | Updated |
| 27/06/2025 | Document: Mechanical ventilator - Notified body 2696 - 10/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP) | New |
| 27/06/2025 | Document: Questions and answers on the outcome of assessment on use of Revolade in treatment of severe aplastic anaemia in children | New |
| 27/06/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025 | Updated |
| 26/06/2025 | PIP: EMEA-003641-PIP01-24 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003640-PIP01-24 - paediatric investigation plan | New |
| 26/06/2025 | Medicine: Kymriah | Updated |
| 26/06/2025 | Medicine: Veklury | Updated |
| 26/06/2025 | PIP: EMEA-003582-PIP01-24 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003577-PIP01-24 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003581-PIP01-24 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003525-PIP01-23 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003463-PIP01-23 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003459-PIP01-23 - paediatric investigation plan | New |
| 26/06/2025 | Referral: Ipidacrine-containing medicinal products - referral | Updated |
| 26/06/2025 | Page: Newsletters | Updated |
| 26/06/2025 | Document: PRIME: 5 years' experience | Updated |
| 26/06/2025 | Medicine: Pavblu | Updated |
| 26/06/2025 | Medicine: Phesgo | Updated |
| 26/06/2025 | Medicine: Januvia | Updated |
| 26/06/2025 | Document: Scientific advice and protocol assistance adopted during the CHMP meeting 19-22 May 2025 | New |
| 26/06/2025 | Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service | New |
| 26/06/2025 | Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service | New |
| 26/06/2025 | Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service | New |
| 26/06/2025 | Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service | New |
| 26/06/2025 | Event: Q&A clinic on Substance, Organisation, Referentials Management Services | New |
| 26/06/2025 | Event: Q&A clinic on Substance, Organisation, Referentials Management Services | New |
| 26/06/2025 | Event: Q&A clinic on Substance, Organisation, Referentials Management Services | New |
| 26/06/2025 | Event: Q&A clinic on Substance, Organisation, Referentials Management Services | New |
| 26/06/2025 | PIP: EMEA-003462-PIP01-23 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-003572-PIP01-23 - paediatric investigation plan | New |
| 26/06/2025 | PIP: EMEA-002600-PIP03-21-M02 - paediatric investigation plan | Updated |
| 26/06/2025 | PIP: EMEA-002572-PIP02-19-M05 - paediatric investigation plan | Updated |
| 25/06/2025 | Event: EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza | Updated |
| 25/06/2025 | Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) | Updated |
| 25/06/2025 | Document: Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 June 2025 | New |
| 25/06/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2025 | Updated |
| 25/06/2025 | Medicine: Miglustat Dipharma | Updated |
| 25/06/2025 | Medicine: Mounjaro | Updated |
| 25/06/2025 | Medicine: Sugammadex Amomed | Updated |
| 25/06/2025 | Event: Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
| 25/06/2025 | Page: European Platform for Regulatory Science Research | New |
| 25/06/2025 | Document: Foclivia : EPAR - All Authorised presentations | Updated |
| 25/06/2025 | Document: Minutes of the CVMP meeting 13-15 May 2025 | New |
| 25/06/2025 | Document: Minutes of the CVMP meeting 8-9 April 2025 | New |
| 25/06/2025 | Document: Minutes of the CVMP meeting 5-7 November 2024 | New |
| 25/06/2025 | Page: Website outages and upgrades | Updated |
| 25/06/2025 | Medicine: Caprelsa | Updated |
| 25/06/2025 | Page: List of medicines under additional monitoring | Updated |
| 25/06/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 25/06/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 25/06/2025 | Page: Developing cancer medicines for children | New |
| 25/06/2025 | PIP: EMEA-003576-PIP01-24 - paediatric investigation plan | New |
| 25/06/2025 | PIP: EMEA-003574-PIP01-24 - paediatric investigation plan | New |
| 25/06/2025 | PIP: EMEA-001809-PIP01-15-M05 - paediatric investigation plan | Updated |
| 25/06/2025 | PIP: EMEA-002489-PIP02-24 - paediatric investigation plan | New |
| 25/06/2025 | PIP: EMEA-001533-PIP01-13-M03 - paediatric investigation plan | Updated |
| 25/06/2025 | PIP: EMEA-000534-PIP03-17-M01 - paediatric investigation plan | Updated |
| 25/06/2025 | Event: Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations | New |
| 25/06/2025 | Medicine: Foclivia | Updated |
| 25/06/2025 | Orphan: EU/3/25/3061 - orphan designation for treatment of GRIN-related neurodevelopmental disorder | New |
| 25/06/2025 | Orphan: EU/3/25/3056 - orphan designation for treatment of soft-tissue sarcoma | New |
| 25/06/2025 | Orphan: EU/3/25/3058 - orphan designation for treatment of idiopathic pulmonary fibrosis | New |
| 25/06/2025 | Orphan: EU/3/25/3055 - orphan designation for diagnosis of ATTR amyloidosis | New |
| 24/06/2025 | Orphan: EU/3/25/3062 - orphan designation for treatment of Danon disease | New |
| 24/06/2025 | Orphan: EU/3/25/3057 - orphan designation for treatment of ricin poisoning | New |
| 24/06/2025 | Orphan: EU/3/25/3053 - orphan designation for treatment of progressive supranuclear palsy | New |
| 24/06/2025 | Orphan: EU/3/25/3064 - orphan designation for treatment of calciphylaxis | New |
| 24/06/2025 | PIP: EMEA-001222-PIP01-11-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000927-PIP01-10-M08 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-001911-PIP02-22-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003196-PIP01-22-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-001821-PIP01-15-M08 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003480-PIP01-23 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-003586-PIP01-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-003535-PIP02-24 - paediatric investigation plan | New |
| 24/06/2025 | Medicine: Beyonttra | Updated |
| 24/06/2025 | PIP: EMEA-003408-PIP02-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-002536-PIP02-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-002907-PIP01-20-M03 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002705-PIP01-19-M02 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002418-PIP01-18-M04 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002093-PIP02-17-M02 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-001911-PIP03-23-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-001862-PIP01-15-M04 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Miglustat Gen.Orph | Updated |
| 24/06/2025 | PIP: EMEA-002740-PIP01-19-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Imuldosa | Updated |
| 24/06/2025 | Medicine: Aripiprazole Sandoz | Updated |
| 24/06/2025 | PIP: EMEA-002827-PIP01-20-M03 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002707-PIP01-19-M02 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003591-PIP01-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-002765-PIP02-21-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002463-PIP01-18-M02 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002889-PIP02-20-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003302-PIP01-22-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000835-PIP01-10-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003260-PIP03-23 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-002338-PIP05-23 - paediatric investigation plan | New |
| 24/06/2025 | Medicine: Orgovyx | Updated |
| 24/06/2025 | PIP: EMEA-003112-PIP01-21-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000834-PIP01-10-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Jemperli | Updated |
| 24/06/2025 | PIP: EMEA-000645-PIP01-09-M09 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Perjeta | Updated |
| 24/06/2025 | PIP: EMEA-001940-PIP01-16-M06 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000836-PIP01-10-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002941-PIP01-20-M05 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-003191-PIP01-22-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Datroway | Updated |
| 24/06/2025 | PIP: EMEA-001951-PIP01-16-M03 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002535-PIP03-19-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000576-PIP01-09-M16 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-000410-PIP01-08-M07 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Cotellic | Updated |
| 24/06/2025 | PIP: EMEA-001164-PIP01-11-M08 - paediatric investigation plan | Updated |
| 24/06/2025 | Event: EMA/HMA annual data forum | New |
| 24/06/2025 | PIP: EMEA-001652-PIP01-14-M06 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Zessly | Updated |
| 24/06/2025 | PIP: EMEA-002432-PIP02-20-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | PIP: EMEA-002268-PIP02-18-M02 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Korjuny | Updated |
| 24/06/2025 | PIP: EMEA-002021-PIP01-16-M01 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Tolucombi | Updated |
| 24/06/2025 | PIP: EMEA-002012-PIP01-16-M05 - paediatric investigation plan | Updated |
| 24/06/2025 | Medicine: Beyfortus | Updated |
| 24/06/2025 | PIP: EMEA-002169-PIP01-17-M03 - paediatric investigation plan | Updated |
| 24/06/2025 | Event: Public event: advancing regulatory science research | Updated |
| 24/06/2025 | PIP: EMEA-003598-PIP01-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-003597-PIP01-24 - paediatric investigation plan | New |
| 24/06/2025 | PIP: EMEA-003596-PIP01-24 - paediatric investigation plan | New |
| 23/06/2025 | PIP: EMEA-003594-PIP01-24 - paediatric investigation plan | New |
| 23/06/2025 | PIP: EMEA-003593-PIP01-24 - paediatric investigation plan | New |
| 23/06/2025 | PIP: EMEA-003593-PIP02-24 - paediatric investigation plan | New |
| 23/06/2025 | Medicine: Neparvis | Updated |
| 23/06/2025 | PIP: EMEA-003192-PIP02-23 - paediatric investigation plan | New |
| 23/06/2025 | Medicine: Entresto | Updated |
| 23/06/2025 | Medicine: Lorviqua | Updated |
| 23/06/2025 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2025 | New |
| 23/06/2025 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October 2025 | New |
| 23/06/2025 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2025 | New |
| 23/06/2025 | PIP: EMEA-002875-PIP02-24 - paediatric investigation plan | New |
| 23/06/2025 | Medicine: Neuraceq | Updated |
| 23/06/2025 | Medicine: Grepid | Updated |
| 23/06/2025 | Medicine: Nustendi | Updated |
| 23/06/2025 | Medicine: Nilemdo | Updated |
| 20/06/2025 | News: EMA starts review of sodium oxybate in alcohol dependence | New |
| 20/06/2025 | Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence - referral | New |
| 20/06/2025 | PIP: EMEA-002354-PIP03-24 - paediatric investigation plan | New |
| 20/06/2025 | PIP: EMEA-003613-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | Medicine: Jakavi | Updated |
| 20/06/2025 | PIP: EMEA-003611-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | Medicine: Lemtrada | Updated |
| 20/06/2025 | PIP: EMEA-003606-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | Medicine: Memantine Merz | Updated |
| 20/06/2025 | PIP: EMEA-003605-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | PIP: EMEA-003600-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | Medicine: Yorvipath | Updated |
| 20/06/2025 | Medicine: Axura | Updated |
| 20/06/2025 | Page: EudraVigilance training and support | Updated |
| 20/06/2025 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - December 2025 | New |
| 20/06/2025 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - October 2025 | New |
| 20/06/2025 | Medicine: Amlodipine / Valsartan Mylan | Updated |
| 20/06/2025 | Medicine: Colobreathe | Updated |
| 20/06/2025 | Post-authorisation: Cabometyx - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Medicine: Usymro | New |
| 20/06/2025 | Medicine: Nintedanib Viatris | New |
| 20/06/2025 | Medicine: Vgenfli | New |
| 20/06/2025 | Medicine: Mynzepli | New |
| 20/06/2025 | Medicine: Vivlipeg | New |
| 20/06/2025 | Medicine: Eiyzey | New |
| 20/06/2025 | Medicine: Imreplys | New |
| 20/06/2025 | Medicine: Afiveg | New |
| 20/06/2025 | Medicine: Ogsiveo | New |
| 20/06/2025 | Post-authorisation: Nubeqa - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Post-authorisation: Imbruvica - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Medicine: Rezdiffra | New |
| 20/06/2025 | Post-authorisation: Sarclisa - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Post-authorisation: Benlysta - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Medicine: Zemcelpro | New |
| 20/06/2025 | Post-authorisation: Darzalex - opinion on variation to marketing authorisation | New |
| 20/06/2025 | Referral: Finasteride- and dutasteride-containing medicinal products - referral | Updated |
| 20/06/2025 | EU-M4all: Dapivirine Vaginal Ring 25 mg - opinion on medicine for use outside EU | Updated |
| 20/06/2025 | Orphan: EU/3/20/2271 - orphan designation for treatment in haematopoietic stem cell transplantation | Updated |
| 20/06/2025 | News: New stem cell therapy to treat patients with blood cancers | New |
| 20/06/2025 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025 | New |
| 20/06/2025 | PIP: EMEA-003599-PIP01-24 - paediatric investigation plan | New |
| 20/06/2025 | News: First treatment against liver scarring caused by a type of ‘fatty liver disease’ | New |
| 20/06/2025 | Document: Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water | New |
| 20/06/2025 | Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025 | Updated |
| 20/06/2025 | Document: Instructions on how to apply for a portfolio & technology meeting (PTM) | Updated |
| 20/06/2025 | Document: Management Board meeting dates 2026-2027 | New |
| 20/06/2025 | Page: Methodology of environmental risk assessment for 5 ectoparasiticidal VMPs for cats and dogs - Scientific guideline | New |
| 20/06/2025 | Document: Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs | New |
| 20/06/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 20/06/2025 | Document: Agenda of the Medicine Shortages SPOC Working Party meeting on 17 June 2025 | New |
| 19/06/2025 | Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services | Updated |
| 19/06/2025 | Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements | Updated |
| 19/06/2025 | Document: Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder group | Updated |
| 19/06/2025 | Medicine: Enjaymo | Updated |
| 19/06/2025 | Medicine: Rizmoic | Updated |
| 19/06/2025 | Medicine: Tysabri | Updated |
| 19/06/2025 | Event: Fourth European Medicines Agency (EMA)-Vaccines Europe bilateral meeting | New |
| 19/06/2025 | Medicine: Pazenir | Updated |
| 19/06/2025 | Herbal: Zingiberis rhizoma - herbal medicinal product | Updated |
| 19/06/2025 | Medicine: Lupkynis | Updated |
| 19/06/2025 | Medicine: Zelboraf | Updated |
| 19/06/2025 | Document: Outcome of written procedures finalised during the period from 4 March 2025 to 28 May 2025 | New |
| 19/06/2025 | Medicine: Ultomiris | Updated |
| 19/06/2025 | Medicine: Tabrecta | Updated |
| 19/06/2025 | Medicine: Jetrea | Updated |
| 19/06/2025 | Medicine: Aquipta | Updated |
| 19/06/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 April 2025 PRAC | Updated |
| 19/06/2025 | Page: How we work | Updated |
| 19/06/2025 | Document: Code of conduct of the European Medicines Agency | Updated |
| 19/06/2025 | Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 | Updated |
| 19/06/2025 | Event: EMA’s 30th anniversary scientific conference - Medicines, regulation and the future | Updated |
| 19/06/2025 | Document: Agenda - EMA’s 30th anniversary scientific conference | Updated |
| 19/06/2025 | Page: Epidemiological data on blood transmissible infections - Scientific guideline | Updated |
| 19/06/2025 | Document: Draft chapter 9 of guideline on epidemiological data on blood transmissible infections | New |
| 19/06/2025 | Document: Union Product Database (UPD) - Quick guide for UPD notifications via the user interface and via email | New |
| 19/06/2025 | Document: Superseded overview of comments received on Community herbal monograph on Zingiber officinale Roscoe, rhizoma | Updated |
| 19/06/2025 | Document: Superseded opinion of the HMPC on a Community herbal monograph on Zingiber officinale Roscoe, rhizoma | Updated |
| 19/06/2025 | Document: Superseded assessment report on Zingiber officinale Roscoe, rhizoma | Updated |
| 19/06/2025 | Document: Superseded Community herbal monograph on Zingiber officinale Roscoe, rhizoma | Updated |
| 19/06/2025 | Document: Superseded list of references supporting the assessment of Zingiber officinale Roscoe, rhizoma | Updated |
| 18/06/2025 | Herbal: Vitis viniferae folium - herbal medicinal product | Updated |
| 18/06/2025 | Medicine: Enspryng | Updated |
| 18/06/2025 | Medicine: Pergoveris | Updated |
| 18/06/2025 | Medicine: Myalepta | Updated |
| 18/06/2025 | Medicine: Sprycel | Updated |
| 18/06/2025 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
| 18/06/2025 | Medicine: Rezzayo | Updated |
| 18/06/2025 | Medicine: Doptelet | Updated |
| 18/06/2025 | Medicine: Xromi | Updated |
| 18/06/2025 | Medicine: Prolia | Updated |
| 18/06/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025 | Updated |
| 18/06/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025 | Updated |
| 18/06/2025 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 18 February 2025 | Updated |
| 18/06/2025 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 13 February 2025 | Updated |
| 18/06/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 4 February 2025 | Updated |
| 18/06/2025 | Document: Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis | New |
| 18/06/2025 | Medicine: Cinryze | Updated |
| 18/06/2025 | Medicine: Phelinun | Updated |
| 18/06/2025 | Medicine: Cyramza | Updated |
| 18/06/2025 | Page: Medicine evaluation figures | Updated |
| 18/06/2025 | Document: Medicinal products for human use: monthly figures - May 2025 | New |
| 18/06/2025 | Medicine: Anzupgo | Updated |
| 18/06/2025 | Medicine: Eltrombopag Accord | Updated |
| 18/06/2025 | Event: Fourth European Medicines Agency and Affordable Medicines Europe bilateral meeting | New |
| 17/06/2025 | Medicine: Velsipity | Updated |
| 17/06/2025 | Medicine: Trumenba | Updated |
| 17/06/2025 | Medicine: Noxafil | Updated |
| 17/06/2025 | Medicine: Aspaveli | Updated |
| 17/06/2025 | Medicine: Tyenne | Updated |
| 17/06/2025 | Medicine: Tafinlar | Updated |
| 17/06/2025 | Medicine: Tecentriq | Updated |
| 17/06/2025 | Medicine: TachoSil | Updated |
| 17/06/2025 | Medicine: Arexvy | Updated |
| 17/06/2025 | Medicine: Xevudy | Updated |
| 17/06/2025 | Medicine: Lumeblue (previously Methylthioninium chloride Cosmo) | Updated |
| 17/06/2025 | Medicine: Aripiprazole Zentiva | Updated |
| 17/06/2025 | Page: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline | Updated |
| 17/06/2025 | Document: Outcome of public consultation on the reflection paper use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes - Summary report of comments received during the public consultation and next steps | New |
| 17/06/2025 | Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes | Updated |
| 17/06/2025 | Document: Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities | Updated |
| 17/06/2025 | Page: Anti-fraud strategy | Updated |
| 17/06/2025 | Document: European Medicines Agency's anti-fraud strategy - revised June 2025 | New |
| 17/06/2025 | Event: Paediatric Committee (PDCO): 17-20 June 2025 | Updated |
| 17/06/2025 | Document: Agenda - PDCO agenda of the 17-20 June 2025 meeting | New |
| 17/06/2025 | Post-authorisation: Inaqovi - withdrawal of application for variation to marketing authorisation | Updated |
| 16/06/2025 | Medicine: Spevigo | Updated |
| 16/06/2025 | Document: Orientation guide for industry - EMA building | Updated |
| 16/06/2025 | Document: Orientation guide for patient representatives and healthcare professionals - EMA building | Updated |
| 16/06/2025 | Document: Orientation guide for delegates - EMA building | Updated |
| 16/06/2025 | Shortage: Dynastat | Updated |
| 16/06/2025 | Document: Agenda - Workshop on the use of Bayesian statistics in clinical development | Updated |
| 16/06/2025 | Page: Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline | Updated |
| 16/06/2025 | PIP: EMEA-002724-PIP01-19-M03 - paediatric investigation plan | Updated |
| 16/06/2025 | Document: Annex to 16-19 June 2025 CHMP Agenda | New |
| 16/06/2025 | Document: Agenda of the CHMP meeting 16-19 June 2025 | New |
| 16/06/2025 | Document: HMA-EMA joint Network Data Steering Group meeting - 30 April 2025 | New |
| 16/06/2025 | PIP: EMEA-002665-PIP02-20-M01 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-002474-PIP02-18-M02 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-002449-PIP02-18-M02 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-002068-PIP01-16-M05 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-001875-PIP02-18-M04 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-001862-PIP03-20-M02 - paediatric investigation plan | Updated |
| 16/06/2025 | Page: Standard for exchange of non-clinical data (SEND): proof-of-concept study | New |
| 16/06/2025 | Document: Questions and answers about the SEND proof-of-concept for industry: Scope, terms of participation and data submission process | New |
| 16/06/2025 | PIP: EMEA-001716-PIP07-22-M01 - paediatric investigation plan | Updated |
| 16/06/2025 | PIP: EMEA-001666-PIP02-21-M01 - paediatric investigation plan | Updated |
| 16/06/2025 | Page: Questions and answers for biological medicinal products | Updated |
| 16/06/2025 | Medicine: Yargesa | Updated |
| 16/06/2025 | Medicine: Imvanex | Updated |
| 16/06/2025 | Medicine: Pyzchiva | Updated |
| 16/06/2025 | Document: Register of deadlines to put a medicinal product on the market In accordance with Article 33 of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 | Updated |
| 16/06/2025 | Page: Human Medicines | Updated |
| 16/06/2025 | Page: Administration and Corporate Management | Updated |
| 16/06/2025 | Document: Organisation chart: Administration and Corporate Management | Updated |
| 16/06/2025 | Document: Organisation chart: Human Medicines | Updated |
| 16/06/2025 | Document: Release notes - production release version 1.7.2523 - 16 June 2025 - Veterinary Medicinal Products Regulation: Union Product Database | New |
| 16/06/2025 | Page: Union Product Database: release notes | Updated |
| 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 | Medicine: Biobhyo | 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: 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: 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 | PIP: EMEA-001407-PIP02-15-M07 - paediatric investigation plan | Updated |
| 12/06/2025 | Medicine: Sugammadex Piramal | 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 | 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 | Page: Medicines for human use under evaluation | Updated |
| 12/06/2025 | Shortage: Perfusion solutions | New |
| 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 | 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: 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-003623-PIP01-24 - paediatric investigation plan | New |
| 11/06/2025 | PIP: EMEA-003624-PIP01-24 - paediatric investigation plan | New |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 05/06/2025 | PIP: EMEA-002600-PIP01-19-M02 - 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 | News: EMA closed 9 June | New |
| 05/06/2025 | Medicine: Tigecycline Accord | 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 |
| 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 | 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 | Medicine: Remicade | Updated |
| 04/06/2025 | Event: Public webinar on shortages: putting patients first | New |
| 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 | 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: 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: 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 | 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 | 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: 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 | 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 | Document: PRAC recommendations on signals adopted at the 5-8 May 2025 meeting | New |
| 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 |
