| 31/03/2025 | News: First report on EU-wide sales and use of antimicrobials in animals | New |
| 31/03/2025 | Page: European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance reports | New |
| 31/03/2025 | Document: European sales and use of antimicrobials for veterinary medicine: Annual surveillance report for 2023 | New |
| 31/03/2025 | Medicine: Giotrif | Updated |
| 31/03/2025 | Medicine: Locametz | Updated |
| 31/03/2025 | Medicine: Zebinix | Updated |
| 31/03/2025 | Page: Scientific data requirements for plasma master file - Scientific guideline | Updated |
| 31/03/2025 | Document: Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes | New |
| 31/03/2025 | Page: Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline | Updated |
| 31/03/2025 | Document: Draft guideline on the quality aspects of mRNA vaccines | New |
| 31/03/2025 | Medicine: Enhertu | Updated |
| 31/03/2025 | Document: Draft Reflection paper on linking to electronic product information (ePI) from EU medicine packages | New |
| 31/03/2025 | Medicine: Amgevita | Updated |
| 31/03/2025 | Medicine: MicardisPlus | Updated |
| 31/03/2025 | Medicine: Nplate | Updated |
| 31/03/2025 | Medicine: Efmody | Updated |
| 31/03/2025 | Medicine: Heplisav B | Updated |
| 31/03/2025 | Medicine: Rukobia | Updated |
| 31/03/2025 | Document: EVVet3 EVWeb Production - Release notes | Updated |
| 31/03/2025 | Page: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): 2009 - 2023 | Updated |
| 31/03/2025 | Document: List of centrally authorised products with safety-related changes to the product information | Updated |
| 28/03/2025 | Medicine: Lydisilka | Updated |
| 28/03/2025 | Medicine: Ontilyv | Updated |
| 28/03/2025 | Medicine: Kevzara | Updated |
| 28/03/2025 | Document: HMPC: overview of assessment work - priority list | Updated |
| 28/03/2025 | Medicine: Ofev | Updated |
| 28/03/2025 | Medicine: Incruse Ellipta (previously Incruse) | Updated |
| 28/03/2025 | Medicine: Nexavar | Updated |
| 28/03/2025 | Medicine: Winrevair | Updated |
| 28/03/2025 | Page: History of EMA | Updated |
| 28/03/2025 | Medicine: Rolufta Ellipta (previously Rolufta) | Updated |
| 28/03/2025 | Document: Day 80 assessment report - Clinical template with guidance - Rev. 03.25 - Revamp | Updated |
| 28/03/2025 | Document: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical | New |
| 28/03/2025 | Post-authorisation: Bosulif - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Medicine: Cinainu | New |
| 28/03/2025 | Post-authorisation: Opdivo - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Post-authorisation: Opdivo - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Post-authorisation: Tevimbra - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Medicine: Insulin Human Rechon | New |
| 28/03/2025 | Post-authorisation: Pemazyre - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Post-authorisation: Calquence - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Medicine: Xoanacyl | New |
| 28/03/2025 | Medicine: Qoyvolma | New |
| 28/03/2025 | Post-authorisation: Amyvid - withdrawal of application for variation to marketing authorisation | New |
| 28/03/2025 | Post-authorisation: Tremfya - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Post-authorisation: Xydalba - opinion on variation to marketing authorisation | New |
| 28/03/2025 | Medicine: Ryjunea | New |
| 28/03/2025 | Medicine: Osvyrti | New |
| 28/03/2025 | Medicine: Jubereq | New |
| 28/03/2025 | Referral: Mysimba - referral | Updated |
| 28/03/2025 | Orphan: EU/3/12/1009 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
| 28/03/2025 | News: EMA concludes review of weight management medicine Mysimba | New |
| 28/03/2025 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025 | New |
| 28/03/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025 | Updated |
| 28/03/2025 | Document: Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 1 April 2025 | New |
| 28/03/2025 | Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC | Updated |
| 28/03/2025 | Document: Policy 85: Identity and Access Management to EMA IT Systems | New |
| 28/03/2025 | Event: Quarterly System Demo - Q1 2025 | Updated |
| 27/03/2025 | Medicine: Laventair Ellipta (previously Laventair) | Updated |
| 27/03/2025 | Medicine: Anoro Ellipta (previously Anoro) | Updated |
| 27/03/2025 | Medicine: Respreeza | Updated |
| 27/03/2025 | Medicine: Zeposia | Updated |
| 27/03/2025 | Event: Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection | Updated |
| 27/03/2025 | Medicine: VeraSeal | Updated |
| 27/03/2025 | Medicine: Uplizna | Updated |
| 27/03/2025 | Medicine: Yuflyma | Updated |
| 27/03/2025 | Medicine: Febuxostat Krka | Updated |
| 27/03/2025 | Medicine: Cresemba | Updated |
| 27/03/2025 | Medicine: INOmax | Updated |
| 27/03/2025 | Document: Minutes of the COMP meeting 18-19 February 2025 | New |
| 27/03/2025 | Document: Annex - National provisions for SMEs applicable to the pharmaceutical sector | Updated |
| 27/03/2025 | Document: Fields and business rules for the European Shortages Monitoring Platform (ESMP) API datasets | New |
| 27/03/2025 | Medicine: Reagila | Updated |
| 27/03/2025 | Medicine: Pluvicto | Updated |
| 27/03/2025 | Medicine: Vafseo | Updated |
| 27/03/2025 | Medicine: Eydenzelt | New |
| 27/03/2025 | Page: European Shortages Monitoring Platform (ESMP) | Updated |
| 27/03/2025 | Document: European shortages monitoring platform (ESMP) API - Instructions to request access for national competent authorities (NCAs) and marketing authorisation holders (MAHs) | New |
| 27/03/2025 | Document: European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for marketing authorisation holders (MAHs) (JSON) (YAML) | New |
| 27/03/2025 | Page: Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group | Updated |
| 27/03/2025 | Document: Guidance for Rapporteurs and members of drafting groups of documents developed by the GMP/GDP Inspectors Working Group | New |
| 27/03/2025 | Document: Three year work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2025-2027 | New |
| 27/03/2025 | Document: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2024 | New |
| 27/03/2025 | Medicine: Brukinsa | Updated |
| 27/03/2025 | Medicine: Strimvelis | Updated |
| 27/03/2025 | Medicine: Eurneffy | Updated |
| 27/03/2025 | Medicine: Rozlytrek | Updated |
| 26/03/2025 | Medicine: Korjuny | Updated |
| 26/03/2025 | Medicine: Vegzelma | Updated |
| 26/03/2025 | Medicine: Cosentyx | Updated |
| 26/03/2025 | Medicine: Columvi | Updated |
| 26/03/2025 | Medicine: Kadcyla | Updated |
| 26/03/2025 | Medicine: Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) | Updated |
| 26/03/2025 | Medicine: Nimvastid | Updated |
| 26/03/2025 | PIP: EMEA-003589-PIP01-24 - paediatric investigation plan | New |
| 26/03/2025 | PIP: EMEA-003512-PIP01-23 - paediatric investigation plan | New |
| 26/03/2025 | PIP: EMEA-003458-PIP01-23 - paediatric investigation plan | New |
| 26/03/2025 | Medicine: Samsca | Updated |
| 26/03/2025 | Medicine: Xenpozyme | Updated |
| 26/03/2025 | PIP: EMEA-003402-PIP01-23 - paediatric investigation plan | New |
| 26/03/2025 | PIP: EMEA-003027-PIP02-23 - paediatric investigation plan | New |
| 26/03/2025 | Page: Website outages and upgrades | Updated |
| 26/03/2025 | Document: Product Management Service (PMS) roadmap | Updated |
| 26/03/2025 | Document: Minutes of the PRAC meeting 13-16 January 2025 | Updated |
| 26/03/2025 | Medicine: Nyxoid | Updated |
| 26/03/2025 | Medicine: Cyramza | Updated |
| 26/03/2025 | Document: Cyramza-H-C-2829-P46-0010 : EPAR - Assessment report | New |
| 26/03/2025 | Medicine: Alofisel | Updated |
| 26/03/2025 | Medicine: Takhzyro | Updated |
| 26/03/2025 | Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data | Updated |
| 26/03/2025 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2025 | New |
| 26/03/2025 | Medicine: Finlee | Updated |
| 26/03/2025 | Document: Decision on rules concerning the handling of declared interests of national experts on secondment, trainees, interims and visiting experts of the European Medicines Agency | Updated |
| 26/03/2025 | Document: Decision of the European Medicines Agency on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment | Updated |
| 26/03/2025 | Document: MedDRA important medical event terms list - version 28.0 | New |
| 26/03/2025 | Page: List of medicines under additional monitoring | Updated |
| 26/03/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 26/03/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 25/03/2025 | Medicine: Emadine | Updated |
| 25/03/2025 | Medicine: Comirnaty | Updated |
| 25/03/2025 | Medicine: Amvuttra | Updated |
| 25/03/2025 | Medicine: Ocrevus | Updated |
| 25/03/2025 | Medicine: EndolucinBeta | Updated |
| 25/03/2025 | Medicine: Sugammadex Fresenius Kabi | Updated |
| 25/03/2025 | Document: Annual list of grants 2024 | New |
| 25/03/2025 | Event: Second EMA / Alliance for Regenerative Medicine bilateral meeting | New |
| 25/03/2025 | Document: CTIS newsflash - 25 March 2025 | New |
| 25/03/2025 | Medicine: Prasugrel Viatris (previously Prasugrel Mylan) | Updated |
| 25/03/2025 | Medicine: Agamree | Updated |
| 25/03/2025 | PIP: EMEA-002945-PIP03-23 - paediatric investigation plan | New |
| 25/03/2025 | Document: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 | Updated |
| 25/03/2025 | Page: Notifying a change of marketing status | Updated |
| 25/03/2025 | PIP: EMEA-002886-PIP02-23 - paediatric investigation plan | New |
| 25/03/2025 | Page: Periodic safety update reports (PSURs) | Updated |
| 25/03/2025 | Page: Post-authorisation safety studies (PASS) | Updated |
| 25/03/2025 | Medicine: Sugammadex Amomed | Updated |
| 25/03/2025 | Medicine: Onpattro | Updated |
| 25/03/2025 | Page: Grouping of variations: questions and answers | Updated |
| 25/03/2025 | Page: Worksharing: questions and answers | Updated |
| 25/03/2025 | Page: Extensions of marketing authorisations: questions and answers | Updated |
| 25/03/2025 | Page: Type-II variations: questions and answers | Updated |
| 25/03/2025 | Page: Type-IB variations: questions and answers | Updated |
| 25/03/2025 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | Updated |
| 25/03/2025 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes | Updated |
| 25/03/2025 | Page: Type-IA variations: questions and answers | Updated |
| 25/03/2025 | Page: Pre-authorisation guidance | Updated |
| 25/03/2025 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure | Updated |
| 25/03/2025 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes | Updated |
| 25/03/2025 | Page: Guidance on the application of the amended Variations Regulation from 1 January 2025 | Updated |
| 25/03/2025 | Document: Agenda - PDCO agenda of the 25-28 March 2025 meeting | New |
| 25/03/2025 | Event: Webinar on reflection paper on the qualification of non-mutagenic impurities | Updated |
| 25/03/2025 | Document: Minutes of the CVMP meeting 11-12 February 2025 | New |
| 25/03/2025 | PIP: EMEA-002796-PIP01-20-M02 - paediatric investigation plan | Updated |
| 25/03/2025 | Event: EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment | New |
| 25/03/2025 | PIP: EMEA-002744-PIP01-19-M01 - paediatric investigation plan | Updated |
| 25/03/2025 | PIP: EMEA-002342-PIP02-18-M03 - paediatric investigation plan | Updated |
| 25/03/2025 | PIP: EMEA-002734-PIP01-19-M01 - paediatric investigation plan | Updated |
| 24/03/2025 | Medicine: Xeljanz | Updated |
| 24/03/2025 | PIP: EMEA-002342-PIP01-18-M04 - paediatric investigation plan | Updated |
| 24/03/2025 | PIP: EMEA-000877-PIP03-17-M05 - paediatric investigation plan | Updated |
| 24/03/2025 | Page: Paediatric investigation plans: questions and answers | Updated |
| 24/03/2025 | Medicine: Siiltibcy | Updated |
| 24/03/2025 | PIP: EMEA-000574-PIP03-23 - paediatric investigation plan | New |
| 24/03/2025 | News: EMA establishes regular procedure for scientific advice on certain high-risk medical devices | Updated |
| 24/03/2025 | Event: Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations | Updated |
| 24/03/2025 | Document: QRD Form 2 and checklist for the submission of day +25 files - veterinary | Updated |
| 24/03/2025 | Document: Minutes of the CAT meeting 4-6 December 2024 | Updated |
| 24/03/2025 | Document: Annex to 24-27 March 2025 CHMP Agenda | New |
| 24/03/2025 | Document: Agenda of the CHMP meeting 24-27 March 2025 | New |
| 24/03/2025 | Medicine: Vimkunya | New |
| 24/03/2025 | Document: Pilot on advice from expert panels to manufacturers of high-risk medical devices: Interim report on the experience with the pilot from February 2023 to December 2024 | New |
| 24/03/2025 | Event: EMA Veterinary Innovation Day | Updated |
| 21/03/2025 | PIP: EMEA-001741-PIP10-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003225-PIP01-22 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003425-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003519-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003520-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003541-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | Medicine: Buvidal | Updated |
| 21/03/2025 | Medicine: Veoza | Updated |
| 21/03/2025 | Medicine: Polivy | Updated |
| 21/03/2025 | Medicine: Drovelis | Updated |
| 21/03/2025 | Event: Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations | Updated |
| 21/03/2025 | Medicine: Enjaymo | Updated |
| 21/03/2025 | Orphan: EU/3/13/1170 - orphan designation for treatment of acromegaly | Updated |
| 21/03/2025 | Medicine: Mycapssa | Updated |
| 21/03/2025 | Page: Union Product Database: release notes | Updated |
| 21/03/2025 | Document: Release notes - production release version 1.7.2514-3 - 21 March 2025 - Veterinary Medical Products Regulation: Union Product Database | New |
| 21/03/2025 | Document: Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) | Updated |
| 20/03/2025 | Document: 2024 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission | New |
| 20/03/2025 | PSUSA: PSUSA/00000329/202407 - periodic safety update report single assessment | New |
| 20/03/2025 | Medicine: Humira | Updated |
| 20/03/2025 | Medicine: Constella | Updated |
| 20/03/2025 | Medicine: Prevenar 13 | Updated |
| 20/03/2025 | Medicine: Sivextro | Updated |
| 20/03/2025 | Medicine: Scintimun | Updated |
| 20/03/2025 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins | Updated |
| 20/03/2025 | Event: Certificates Processing System: Demo & Q&A session for industry stakeholders | Updated |
| 20/03/2025 | Document: Minutes of the HMPC meeting 20-22 January 2025 | New |
| 20/03/2025 | News: EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples | New |
| 20/03/2025 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
| 20/03/2025 | DHPC: Emblaveo - direct healthcare professional communication (DHPC) | New |
| 20/03/2025 | Medicine: Idefirix | Updated |
| 20/03/2025 | Medicine: Voxzogo | Updated |
| 19/03/2025 | Medicine: Namuscla | Updated |
| 19/03/2025 | Medicine: Pomalidomide Krka | Updated |
| 19/03/2025 | PSUSA: PSUSA/00010511/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | Medicine: Tenofovir disoproxil Zentiva | Updated |
| 19/03/2025 | Medicine: Leflunomide ratiopharm | Updated |
| 19/03/2025 | Medicine: Jayempi | Updated |
| 19/03/2025 | Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) | Updated |
| 19/03/2025 | Medicine: Tolura | Updated |
| 19/03/2025 | Medicine: Rivastigmine Actavis | Updated |
| 19/03/2025 | Medicine: Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 19/03/2025 | PSUSA: PSUSA/00002944/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | Medicine: Fymskina | Updated |
| 19/03/2025 | PSUSA: PSUSA/00002087/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | PSUSA: PSUSA/00000081/202408 - periodic safety update report single assessment | New |
| 19/03/2025 | PIP: EMEA-003149-PIP01-21-M02 - paediatric investigation plan | Updated |
| 19/03/2025 | Event: Webinar on PMS Project Made Easy: Summary of activities and Practical Tips for SMEs | Updated |
| 19/03/2025 | Document: Medicinal products for human use: monthly figures - February 2025 | New |
| 19/03/2025 | Document: QRD statements for metered dose inhalers containing fluorinated greenhouse gases | Updated |
| 19/03/2025 | Document: 2024 European Medicines Agency annual report on independence | New |
| 19/03/2025 | Page: Applying for marketing authorisation: orphan medicines | Updated |
| 18/03/2025 | Medicine: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 18/03/2025 | EU-M4all: Ivermectin/Albendazole - opinion on medicine for use outside EU | Updated |
| 18/03/2025 | Medicine: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) | Updated |
| 18/03/2025 | PIP: EMEA-000410-PIP01-08-M06 - paediatric investigation plan | Updated |
| 18/03/2025 | Document: Agenda of the CAT meeting 19-21 March 2025 | New |
| 18/03/2025 | Page: ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline | Updated |
| 18/03/2025 | Document: ICH M11 Technical Specification - Updated step 2b | New |
| 18/03/2025 | Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 | Updated |
| 18/03/2025 | PIP: EMEA-003514-PIP02-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003514-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003504-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003438-PIP02-23 - paediatric investigation plan | New |
| 18/03/2025 | News: Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028 | New |
| 18/03/2025 | Document: Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (final) | New |
| 18/03/2025 | Document: Analysis and summaries of public consultation results: The European medicines agencies network strategy to 2028 | New |
| 18/03/2025 | PIP: EMEA-003426-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | Event: EMA traineeship programme informative session | New |
| 17/03/2025 | Medicine: Leucofeligen FeLV/RCP | Updated |
| 17/03/2025 | Medicine: Cimalgex | Updated |
| 17/03/2025 | Medicine: Cytopoint | Updated |
| 17/03/2025 | Medicine: Steglatro | Updated |
| 17/03/2025 | Medicine: Skilarence | Updated |
| 17/03/2025 | Event: European Organisation for Research and Treatment of Cancer (EORTC) bilateral meeting | New |
| 17/03/2025 | Medicine: Lazcluze | Updated |
| 17/03/2025 | Medicine: Yervoy | Updated |
| 17/03/2025 | PIP: EMEA-003389-PIP01-23 - paediatric investigation plan | New |
| 17/03/2025 | Document: 2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG) | Updated |
| 17/03/2025 | Medicine: Uptravi | Updated |
| 17/03/2025 | PIP: EMEA-003300-PIP01-22 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002951-PIP02-21 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002817-PIP05-23 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002618-PIP04-23 - paediatric investigation plan | New |
| 17/03/2025 | Page: Methylphenidate product-specific bioequivelance guidance | New |
| 17/03/2025 | PIP: EMEA-002600-PIP03-21-M01 - paediatric investigation plan | Updated |
| 17/03/2025 | PIP: EMEA-002582-PIP03-23 - paediatric investigation plan | New |
| 17/03/2025 | Event: Finding clinical trials with the ACT EU Trial Map | Updated |
| 17/03/2025 | Document: PRAC recommendations on signals adopted at the 10-13 February 2025 meeting | New |
| 14/03/2025 | Medicine: Revinty Ellipta | Updated |
| 14/03/2025 | Event: ADRA project - information session for veterinary pharmaceutical industry | Updated |
| 14/03/2025 | PSUSA: PSUSA/00000406/202408 - periodic safety update report single assessment | New |
| 14/03/2025 | Event: European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs) | Updated |
| 14/03/2025 | Medicine: Prevexxion RN | Updated |
| 14/03/2025 | Document: Agenda - Management Board meeting: 13 March 2025 | Updated |
| 14/03/2025 | Medicine: Mhyosphere PCV ID | Updated |
| 14/03/2025 | Medicine: Koselugo | Updated |
| 14/03/2025 | Medicine: Porcilis PCV | Updated |
| 14/03/2025 | Document: Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months | Updated |
| 14/03/2025 | Medicine: mResvia | Updated |
| 14/03/2025 | PIP: EMEA-002578-PIP01-19-M01 - paediatric investigation plan | Updated |
| 14/03/2025 | Medicine: Dimethyl fumarate Accord | Updated |
| 14/03/2025 | Medicine: Yesafili | Updated |
| 14/03/2025 | Medicine: Prazivetin | New |
| 14/03/2025 | Medicine: Nobilis Multriva IBm+ND+EDS | New |
| 14/03/2025 | Medicine: Prevestrus vet | New |
| 14/03/2025 | Post-authorisation: Rheumocam - opinion on variation to marketing authorisation | New |
| 14/03/2025 | Medicine: Hepizovac | New |
| 14/03/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 March 2025 | New |
| 14/03/2025 | News: First vaccine against epizootic haemorrhagic disease recommended for approval | New |
| 14/03/2025 | PIP: EMEA-002566-PIP01-19-M01 - paediatric investigation plan | Updated |
| 14/03/2025 | Page: Frequently asked questions | Updated |
| 14/03/2025 | PIP: EMEA-002559-PIP09-23 - paediatric investigation plan | New |
| 14/03/2025 | Document: Frequently asked questions (FAQs): How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 | Updated |
| 14/03/2025 | PIP: EMEA-002451-PIP01-18-M02 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-002350-PIP01-18-M03 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-002303-PIP01-17-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | Document: User guide for micro, small and medium-sized enterprises | Updated |
| 14/03/2025 | News: EMA Management Board: highlights of March 2025 meeting | New |
| 14/03/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 March 2025 | New |
| 14/03/2025 | PIP: EMEA-002141-PIP01-17-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001949-PIP02-18-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001949-PIP01-16-M06 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001900-PIP02-17-M08 - paediatric investigation plan | Updated |
| 14/03/2025 | Medicine: Gardasil 9 | Updated |
| 14/03/2025 | Medicine: Silodyx | Updated |
| 13/03/2025 | PSUSA: PSUSA/00010390/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | PSUSA: PSUSA/00010598/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | PSUSA: PSUSA/00002256/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | Herbal: Oleae folium - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Cynarae folium - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Avenae herba - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Avenae fructus - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Verbasci flos - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Sambuci flos - herbal medicinal product | Updated |
| 13/03/2025 | Page: Network Portfolio | Updated |
| 13/03/2025 | PIP: EMEA-001888-PIP01-15-M02 - paediatric investigation plan | Updated |
| 13/03/2025 | PIP: EMEA-001741-PIP01-14-M07 - paediatric investigation plan | Updated |
| 13/03/2025 | Medicine: Zolsketil pegylated liposomal | Updated |
| 13/03/2025 | Event: European Shortages Monitoring (ESMP) - Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP | Updated |
| 13/03/2025 | PIP: EMEA-000205-PIP02-11-M06 - paediatric investigation plan | Updated |
| 13/03/2025 | Medicine: Imraldi | Updated |
| 13/03/2025 | Medicine: Naveruclif | Updated |
| 13/03/2025 | Document: Release notes - production release version 1.7.2514 - 12 March 2025 - Veterinary Medical Products Regulation: Union Product Database | Updated |
| 13/03/2025 | PIP: EMEA-001213-PIP03-23 - paediatric investigation plan | New |
| 13/03/2025 | Document: Network Portfolio Roadmap | Updated |
| 13/03/2025 | Page: High-risk medical devices: consultation procedures and advice | Updated |
| 13/03/2025 | Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment | New |
| 13/03/2025 | Document: Drug-Eluting stent (DES) - Notified Body 2265 - 10/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP) | New |
| 13/03/2025 | PIP: EMEA-000383-PIP04-23 - paediatric investigation plan | New |
| 13/03/2025 | News: Unregulated advanced therapy medicinal products pose serious risks to health | New |
| 13/03/2025 | Medicine: Imcivree | Updated |
| 13/03/2025 | Medicine: Xgeva | Updated |
| 13/03/2025 | Herbal: Polypodii rhizoma - herbal medicinal product | Updated |
| 13/03/2025 | News: EMA Management Board elects new chair | New |
| 13/03/2025 | Document: Agenda of the HMPC meeting 17-19 March 2025 | New |
| 12/03/2025 | PIP: EMEA-000309-PIP07-21-M01 - paediatric investigation plan | Updated |
| 12/03/2025 | Orphan: EU/3/20/2347 - orphan designation for treatment of neuronal ceroid lipofuscinosis | Updated |
| 12/03/2025 | Orphan: EU/3/23/2836 - orphan designation for treatment of Guillain-Barré syndrome | Updated |
| 12/03/2025 | Orphan: EU/3/16/1609 - orphan designation for treatment of autoimmune haemolytic anaemia | Updated |
| 12/03/2025 | Orphan: EU/3/22/2723 - orphan designation for treatment of ovarian cancer | Updated |
| 12/03/2025 | Orphan: EU/3/20/2247 - orphan designation for treatment of myelofibrosis | Updated |
| 12/03/2025 | Orphan: EU/3/19/2149 - orphan designation for treatment of Huntington’s disease | Updated |
| 12/03/2025 | Orphan: EU/3/11/945 - orphan designation for treatment of acute liver failure | Updated |
| 12/03/2025 | Orphan: EU/3/22/2731 - orphan designation for treatment of small cell lung cancer | Updated |
| 12/03/2025 | Orphan: EU/3/24/3011 - orphan designation for treatment of myasthenia gravis | Updated |
| 12/03/2025 | Orphan: EU/3/17/1930 - orphan designation for treatment of primary biliary cholangitis | Updated |
| 12/03/2025 | Orphan: EU/3/20/2288 - orphan designation for treatment of myelodysplastic syndromes | Updated |
| 12/03/2025 | Orphan: EU/3/15/1582 - orphan designation for treatment of acute myeloid leukaemia | Updated |
| 12/03/2025 | Herbal: Lini semen - herbal medicinal product | Updated |
| 12/03/2025 | Herbal: Urticae radix - herbal medicinal product | Updated |
| 12/03/2025 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
| 12/03/2025 | Medicine: Evusheld | Updated |
| 12/03/2025 | Medicine: Sugammadex Mylan | Updated |
| 12/03/2025 | Medicine: Yselty | Updated |
| 12/03/2025 | Medicine: Rekambys | Updated |
| 12/03/2025 | Medicine: Gencebok | Updated |
| 12/03/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 12/03/2025 | Document: Summary of the Medicine Shortages SPOC Working Party meeting on 21 January 2025 | New |
| 12/03/2025 | PIP: EMEA-003043-PIP01-21-M01 - paediatric investigation plan | Updated |
| 12/03/2025 | Medicine: Wainzua | Updated |
| 12/03/2025 | Document: CTIS newsflash - 11 March 2025 | New |
| 12/03/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 12/03/2025 | Document: Final European Union herbal monograph on Urtica dioica L.; Urtica urens L., radix - Revision 1 | Updated |
| 12/03/2025 | Document: Final list of references supporting the assessment of Urtica dioica L.; Urtica urens L., radix - Revision 1 | Updated |
| 12/03/2025 | Document: Minutes - PDCO minutes of the 28-31 January 2025 meeting | New |
| 12/03/2025 | Document: Superseded Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded opinion of the HMPC on Urtica dioica L., Urtica urens L. their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded assessment report on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded list of references supporting the assessment of Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded overview of comments received on Community herbal monograph on Urtica dioica L., Urtica urens L. their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Medicine: Sarclisa | Updated |
| 12/03/2025 | Event: Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders | Updated |
| 12/03/2025 | Event: Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders | Updated |
| 12/03/2025 | Document: European Medicines Agency's data protection notice on the use of SNDS data for the performance of DARWIN EU® studies on incidence and prevalence of pathologies and use of drugs in the French population | New |
| 12/03/2025 | Page: Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline | Updated |
| 12/03/2025 | Medicine: Vocabria | Updated |
| 11/03/2025 | Medicine: Rytelo | Updated |
| 11/03/2025 | Medicine: Paxneury | Updated |
| 11/03/2025 | Medicine: Andembry | Updated |
| 11/03/2025 | Medicine: Rybrevant | Updated |
| 11/03/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 11/03/2025 | Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting 24-27 February 2025 | New |
| 11/03/2025 | Orphan: EU/3/25/3027 - orphan designation for treatment of follicular lymphoma | New |
| 11/03/2025 | Orphan: EU/3/15/1478 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
| 11/03/2025 | Orphan: EU/3/25/3030 - orphan designation for treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing | New |
| 11/03/2025 | Orphan: EU/3/17/1954 - orphan designation for treatment of mantle cell lymphoma | Updated |
| 11/03/2025 | Orphan: EU/3/25/3033 - orphan designation for treatment of arrhythmogenic cardiomyopathy caused by pathogenic mutations in the PKP2 gene | New |
| 11/03/2025 | Orphan: EU/3/25/3032 - orphan designation for treatment of Olmsted syndrome | New |
| 11/03/2025 | Orphan: EU/3/16/1766 - orphan designation for treatment of diffuse large B-cell lymphoma | Updated |
| 11/03/2025 | Orphan: EU/3/05/334 - orphan designation for treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome) | Updated |
| 11/03/2025 | Orphan: EU/3/25/3035 - orphan designation for treatment of acromegaly | New |
| 11/03/2025 | Orphan: EU/3/25/3026 - orphan designation for treatment of hyperphenylalaninaemia | New |
| 11/03/2025 | Orphan: EU/3/25/3029 - orphan designation for treatment of primary sclerosing cholangitis | New |
| 11/03/2025 | Orphan: EU/3/25/3028 - orphan designation for treatment of amyotrophic lateral sclerosis | New |
| 11/03/2025 | Orphan: EU/3/25/3034 - orphan designation for treatment of adenosine deaminase 2 deficiency (DADA2) | New |
| 11/03/2025 | Medicine: Emcitate | Updated |
| 11/03/2025 | Orphan: EU/3/25/3031 - orphan designation for treatment of limb-girdle muscular dystrophy | New |
| 11/03/2025 | Shortage: Quetiapine | New |
| 11/03/2025 | Event: Cancer Medicines Forum: December 2024 | New |
| 11/03/2025 | Document: Presentation - Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases: FDA guidance (Mirat Shah) | New |
| 11/03/2025 | Document: Minutes of the Cancer Medicines Forum - December 2024 | New |
| 10/03/2025 | Event: Human variation electronic application form (eAF) training session and Q&A clinic | Updated |
| 10/03/2025 | Event: Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs | Updated |
| 10/03/2025 | Medicine: Inaqovi | Updated |
| 10/03/2025 | Medicine: Sutent | Updated |
| 10/03/2025 | Medicine: Entresto | Updated |
| 10/03/2025 | Medicine: Neparvis | Updated |
| 10/03/2025 | Medicine: Silodosin Recordati | Updated |
| 10/03/2025 | Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP) | Updated |
| 10/03/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 March 2025 | Updated |
| 10/03/2025 | Document: Agenda of the PRAC meeting 10-13 March 2025 | New |
| 10/03/2025 | Medicine: Blincyto | Updated |
| 10/03/2025 | Document: Agenda of the CVMP meeting 11-13 March 2025 | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML) | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) Application Programming Interface (API) specifications | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) data access policy - Annex A: Data elements accessible by ESMP access level | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) data access policy | New |
| 10/03/2025 | Page: Antimicrobial resistance in veterinary medicine | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities | Updated |
| 10/03/2025 | Medicine: Entecavir Viatris (previously Entecavir Mylan) | Updated |
| 10/03/2025 | Page: Veterinary product information (QRD) templates | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders | Updated |
| 07/03/2025 | PSUSA: PSUSA/00010199/202405 - periodic safety update report single assessment | New |
| 07/03/2025 | PSUSA: PSUSA/00001761/202404 - periodic safety update report single assessment | New |
| 07/03/2025 | PSUSA: PSUSA/00000048/202406 - periodic safety update report single assessment | New |
| 07/03/2025 | PIP: EMEA-003470-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Herbal: Urticae herba - herbal medicinal product | Updated |
| 07/03/2025 | Document: Final European Union herbal monograph on Urtica dioica L.; Urtica urens L., herba - Revision 1 | Updated |
| 07/03/2025 | Medicine: Pedea | Updated |
| 07/03/2025 | Document: Minutes of the CHMP meeting on 14-17 October 2024 | New |
| 07/03/2025 | Orphan: EU/3/08/579 - orphan designation for corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns | Updated |
| 07/03/2025 | Medicine: Holoclar | Updated |
| 07/03/2025 | Medicine: Bridion | Updated |
| 07/03/2025 | Medicine: Ibrance | Updated |
| 07/03/2025 | Medicine: Verzenios | Updated |
| 07/03/2025 | Medicine: BeneFIX | Updated |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025 | New |
| 07/03/2025 | Event: Q&A clinic on human variations web-based electronic application form (eAF) | Updated |
| 07/03/2025 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
| 07/03/2025 | Event: Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs | Updated |
| 07/03/2025 | Event: Info session on web-based electronic Application Form (eAF) add package | Updated |
| 07/03/2025 | PIP: EMEA-003476-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - June 2025 | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025 | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025 | New |
| 07/03/2025 | Medicine: Nobilis Multriva REOm | Updated |
| 07/03/2025 | PIP: EMEA-003475-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Kimmtrak | Updated |
| 07/03/2025 | Medicine: Brinavess | Updated |
| 07/03/2025 | PIP: EMEA-001911-PIP02-22 - paediatric investigation plan | New |
| 07/03/2025 | PIP: EMEA-003498-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Truqap | Updated |
| 07/03/2025 | Medicine: Equilis Prequenza | Updated |
| 07/03/2025 | PIP: EMEA-003466-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Recarbrio | Updated |
| 07/03/2025 | Medicine: Equilis Te | Updated |
| 07/03/2025 | Page: COVID-19 medicines | Updated |
| 07/03/2025 | Medicine: Equilis Prequenza Te | Updated |
| 07/03/2025 | Document: Minutes of the CHMP meeting 11-14 November 2024 | New |
| 07/03/2025 | Event: Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS | Updated |
| 07/03/2025 | Document: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (1 January - 31 December 2024) | Updated |
| 06/03/2025 | PIP: EMEA-003238-PIP02-22 - paediatric investigation plan | New |
| 06/03/2025 | PIP: EMEA-003237-PIP02-22 - paediatric investigation plan | New |
| 06/03/2025 | Medicine: Hexyon | Updated |
| 06/03/2025 | Medicine: Rybelsus | Updated |
| 06/03/2025 | Medicine: Eltrombopag Viatris | Updated |
| 06/03/2025 | Medicine: Ulunar Breezhaler | Updated |
| 06/03/2025 | PSUSA: PSUSA/00010483/202406 - periodic safety update report single assessment | New |
| 06/03/2025 | Medicine: Tygacil | Updated |
| 06/03/2025 | Medicine: Pregabalin Viatris (previously Pregabalin Mylan) | Updated |
| 06/03/2025 | PIP: EMEA-000402-PIP03-17-M08 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000325-PIP01-08-M11 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000128-PIP02-09-M05 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000016-PIP01-07-M09 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-002963-PIP01-21-M01 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-002950-PIP01-20-M01 - paediatric investigation plan | Updated |
| 06/03/2025 | Medicine: Yorvipath | Updated |
| 06/03/2025 | PIP: EMEA-001032-PIP01-10-M07 - paediatric investigation plan | Updated |
| 06/03/2025 | Medicine: Bemrist Breezhaler | Updated |
| 06/03/2025 | Medicine: Atectura Breezhaler | Updated |
| 05/03/2025 | Medicine: Hexacima | Updated |
| 05/03/2025 | Medicine: Dynastat | Updated |
| 05/03/2025 | Medicine: Cimzia | Updated |
| 05/03/2025 | Medicine: Zimbus Breezhaler | Updated |
| 05/03/2025 | Medicine: Quofenix | Updated |
| 05/03/2025 | Medicine: Enerzair Breezhaler | Updated |
| 05/03/2025 | Medicine: Benepali | Updated |
| 05/03/2025 | Medicine: Neoclarityn | Updated |
| 05/03/2025 | Medicine: Azomyr | Updated |
| 05/03/2025 | Medicine: Aerius | Updated |
| 05/03/2025 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
| 05/03/2025 | Medicine: Syvazul BTV 3 | Updated |
| 05/03/2025 | Medicine: Bluevac-3 | Updated |
| 05/03/2025 | Medicine: Skyrizi | Updated |
| 05/03/2025 | Medicine: Lenalidomide Mylan | Updated |
| 05/03/2025 | Event: Union product database: webinar for veterinary marketing authorisation holders on an industry dedicated read API | Updated |
| 05/03/2025 | Document: Annex to 24-27 February 2025 CHMP Agenda | Updated |
| 05/03/2025 | Document: Frequently asked questions (FAQs) : How to create and submit an annual safety report and respond to related requests for information - CTIS Training Programme - Module 18 | Updated |
| 05/03/2025 | Document: Minutes - PDCO minutes of the 12-15 November 2024 meeting | Updated |
| 05/03/2025 | Medicine: Remsima | Updated |
| 05/03/2025 | Document: Vitrolife IVF media - Procedural steps and scientific information after initial consultation | Updated |
| 05/03/2025 | Medicine: Eylea | Updated |
| 05/03/2025 | Medicine: Tarceva | Updated |
| 05/03/2025 | Medicine: Awiqli | Updated |
| 05/03/2025 | Medicine: Alimta | Updated |
| 05/03/2025 | Medicine: Inrebic | Updated |
| 05/03/2025 | Medicine: ReFacto AF | Updated |
| 04/03/2025 | Medicine: Viagra | Updated |
| 04/03/2025 | Medicine: Ibandronic acid Accord | Updated |
| 04/03/2025 | Medicine: Coagadex | Updated |
| 04/03/2025 | Medicine: Toviaz | Updated |
| 04/03/2025 | Medicine: Ryzodeg | Updated |
| 04/03/2025 | Medicine: Viramune | Updated |
| 04/03/2025 | PIP: EMEA-002727-PIP02-23 - paediatric investigation plan | New |
| 04/03/2025 | Medicine: Skyclarys | Updated |
| 04/03/2025 | PIP: EMEA-003484-PIP01-23 - paediatric investigation plan | New |
| 04/03/2025 | Medicine: Baiama | Updated |
| 04/03/2025 | Medicine: Mirvaso | Updated |
| 03/03/2025 | PSUSA: PSUSA/00002943/202406 - periodic safety update report single assessment | New |
| 03/03/2025 | Medicine: Xoterna Breezhaler | Updated |
| 03/03/2025 | Medicine: Tecartus | Updated |
| 03/03/2025 | Medicine: Anagrelide Viatris (previously Anagrelide Mylan) | Updated |
| 03/03/2025 | Medicine: Orserdu | Updated |
| 03/03/2025 | Medicine: Ultibro Breezhaler | Updated |
| 03/03/2025 | Medicine: Obodence | Updated |
| 03/03/2025 | Medicine: Nepexto | Updated |
| 03/03/2025 | Medicine: Beyonttra | Updated |
| 03/03/2025 | News: New clinical trial map launched in the EU | New |
| 03/03/2025 | Page: Clinical Trials Information System | Updated |
| 03/03/2025 | Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions | Updated |
| 03/03/2025 | Medicine: Spherox | Updated |
| 03/03/2025 | Medicine: Efient | Updated |
| 03/03/2025 | Medicine: Litfulo | Updated |
| 03/03/2025 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
| 03/03/2025 | Medicine: MenQuadfi | Updated |
| 03/03/2025 | Medicine: Ruconest | Updated |
| 03/03/2025 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
| 03/03/2025 | Medicine: Modigraf | Updated |
| 03/03/2025 | Event: Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach | Updated |
| 03/03/2025 | Event: Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal | Updated |
| 03/03/2025 | Medicine: Torisel | Updated |
