| 28/06/2024 | Medicine: Palladia | Updated |
| 28/06/2024 | Medicine: Zuprevo | Updated |
| 28/06/2024 | Medicine: Ypozane | Updated |
| 28/06/2024 | Medicine: Zactran | Updated |
| 28/06/2024 | Medicine: SevoFlo | Updated |
| 28/06/2024 | Medicine: Bravecto Plus | Updated |
| 28/06/2024 | Medicine: Naxcel | Updated |
| 28/06/2024 | Medicine: Onsior | Updated |
| 28/06/2024 | Medicine: Aservo EquiHaler | Updated |
| 28/06/2024 | Medicine: Stronghold | Updated |
| 28/06/2024 | Medicine: Cerenia | Updated |
| 28/06/2024 | Document: Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points | Updated |
| 28/06/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Notifications and results | Updated |
| 28/06/2024 | Medicine: Xerava | Updated |
| 28/06/2024 | Event: Public webinar on pack size submissions: from XEVMPD to product management service (PMS) | Updated |
| 28/06/2024 | Document: Agenda - Public webinar on pack size submissions: from XEVMPD to product management service (PMS) | New |
| 28/06/2024 | Event: Product Management Service (PMS) Application Programming Interface (API) training session | Updated |
| 28/06/2024 | Medicine: Zabdeno | Updated |
| 28/06/2024 | Page: Plasma master file certificates | Updated |
| 28/06/2024 | Event: Quarterly System Demo – Q2 2024 | Updated |
| 28/06/2024 | Page: Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline | Updated |
| 28/06/2024 | Medicine: Vizamyl | Updated |
| 28/06/2024 | Medicine: Mepsevii | Updated |
| 28/06/2024 | Post-authorisation: Cresemba - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Page: Clinical investigation of recombinant and human plasma-derived factor IX products - Scientific guideline | Updated |
| 28/06/2024 | Referral: Lorazepam Macure 4 mg/ml, solution for injection - referral | New |
| 28/06/2024 | Medicine: Nplate | Updated |
| 28/06/2024 | Medicine: Spinraza | Updated |
| 28/06/2024 | Document: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) | Updated |
| 28/06/2024 | Document: Clinical Trial Information System (CTIS) - Sponsor handbook | Updated |
| 28/06/2024 | Document: Paediatric investigation plan (PIP) - Key elements guidance | Updated |
| 28/06/2024 | Document: CTIS newsflash - 28 June 2024 | New |
| 28/06/2024 | Medicine: Neulasta | Updated |
| 28/06/2024 | Medicine: Repatha | Updated |
| 28/06/2024 | Medicine: Aranesp | Updated |
| 28/06/2024 | Medicine: Aspaveli | Updated |
| 28/06/2024 | Medicine: Talvey | Updated |
| 28/06/2024 | Page: Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline | Updated |
| 28/06/2024 | Page: Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline | Updated |
| 28/06/2024 | Document: Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle | New |
| 28/06/2024 | Medicine: Aquipta | Updated |
| 28/06/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 | New |
| 28/06/2024 | Post-authorisation: Vabysmo - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Tepkinly - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Beyfortus - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Betmiga - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Imcivree - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Medicine: Balversa | New |
| 28/06/2024 | Medicine: Ordspono | New |
| 28/06/2024 | Post-authorisation: Infanrix Hexa - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Medicine: Piasky | New |
| 28/06/2024 | Post-authorisation: Xalkori - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Imfinzi - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Post-authorisation: Lynparza - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Medicine: Winrevair | New |
| 28/06/2024 | Post-authorisation: Pegasys - opinion on variation to marketing authorisation | New |
| 28/06/2024 | Medicine: Enzalutamide Viatris | New |
| 28/06/2024 | Medicine: Nilotinib Accord | New |
| 28/06/2024 | Medicine: Dabigatran etexilate Teva | New |
| 28/06/2024 | Medicine: Eurneffy | New |
| 28/06/2024 | Medicine: Mresvia | New |
| 28/06/2024 | Referral: Hydroxyprogesterone caproate-containing medicinal products - referral | Updated |
| 28/06/2024 | Orphan: EU/3/20/2369 - orphan designation for treatment of pulmonary arterial hypertension | Updated |
| 28/06/2024 | Orphan: EU/3/22/2649 - orphan designation for treatment of follicular lymphoma | Updated |
| 28/06/2024 | Orphan: EU/3/22/2656 - orphan designation for treatment of diffuse large B-cell lymphoma | Updated |
| 28/06/2024 | News: EMA recommends revoking conditional marketing authorisation for Ocaliva | New |
| 28/06/2024 | News: Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension | New |
| 28/06/2024 | News: First nasal adrenaline spray for emergency treatment against allergic reactions | New |
| 28/06/2024 | Document: Transfer of MA templates Attachment 6.1 (Superseded) | Updated |
| 28/06/2024 | Document: Questions and answers on classification of veterinary medicinal products | New |
| 28/06/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 May 2024 | Updated |
| 28/06/2024 | Document: Minutes of the CVMP meeting 21-22 May 2024 | New |
| 28/06/2024 | Document: Transfer of MA templates Attachment 4 (Superseded) | Updated |
| 28/06/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024 | Updated |
| 28/06/2024 | Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-29 May 2024 | New |
| 28/06/2024 | News: EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna | New |
| 28/06/2024 | Document: Transfer of MA templates - Attachment 5 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 6.2 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 6.3 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 6.4 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 7 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 8 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 9 (Superseded) | Updated |
| 28/06/2024 | Document: Transfer of MA templates Attachment 6.1.1 (No longer valid) | Updated |
| 27/06/2024 | Medicine: Xydalba | Updated |
| 27/06/2024 | Document: Agenda of the CHMP meeting 24-27 June 2024 | Updated |
| 27/06/2024 | Document: Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation | Updated |
| 27/06/2024 | Medicine: Adcetris | Updated |
| 27/06/2024 | Medicine: Xtandi | Updated |
| 27/06/2024 | Medicine: Rydapt | Updated |
| 27/06/2024 | Medicine: Uzpruvo | Updated |
| 27/06/2024 | Event: Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors - October 2024 | New |
| 27/06/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2024 | New |
| 27/06/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October 2024 | New |
| 27/06/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2024 | New |
| 27/06/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - September 2024 | Updated |
| 27/06/2024 | Document: Agenda - Ad-hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), 1 July 2024 | New |
| 27/06/2024 | Medicine: Cinacalcet Accordpharma | Updated |
| 27/06/2024 | Page: Business hours and holidays | Updated |
| 27/06/2024 | Medicine: Inhixa | Updated |
| 27/06/2024 | Document: Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use | Updated |
| 27/06/2024 | Medicine: Veklury | Updated |
| 27/06/2024 | Medicine: Zeposia | Updated |
| 27/06/2024 | Medicine: Eylea | Updated |
| 27/06/2024 | Medicine: Orencia | Updated |
| 27/06/2024 | Medicine: Livmarli | Updated |
| 26/06/2024 | Orphan: EU/3/08/596 - orphan designation for treatment of Hodgkin's lymphoma | Updated |
| 26/06/2024 | Orphan: EU/3/11/939 - orphan designation for treatment of cutaneous T-cell lymphoma | Updated |
| 26/06/2024 | Orphan: EU/3/08/595 - orphan designation for treatment of peripheral T-cell lymphoma | Updated |
| 26/06/2024 | Document: Annex XV - List of topiramate containing medicinal products in the European Union | Updated |
| 26/06/2024 | Document: Annex XV - List of topiramate containing medicinal products in the European Union | Updated |
| 26/06/2024 | Document: List of medicinal products under additional monitoring | Updated |
| 26/06/2024 | Document: List of medicinal products under additional monitoring | Updated |
| 26/06/2024 | Medicine: RoActemra | Updated |
| 26/06/2024 | Document: MSSG recommendations on shortage of Glucagon-Like Peptide-1 (GLP-1) receptor agonists | New |
| 26/06/2024 | News: EU actions to tackle shortages of GLP-1 receptor agonists | New |
| 26/06/2024 | Medicine: Vanflyta | Updated |
| 26/06/2024 | Page: Availability of medicines before and during crises | Updated |
| 26/06/2024 | Medicine: Valdoxan | Updated |
| 26/06/2024 | Medicine: Artesunate Amivas | Updated |
| 26/06/2024 | Event: Twelfth meeting of the industry stakeholder platform on research and development support | New |
| 26/06/2024 | Medicine: Yervoy | Updated |
| 26/06/2024 | Medicine: Leflunomide Zentiva (previously Leflunomide Winthrop) | Updated |
| 26/06/2024 | Medicine: Fluenz | Updated |
| 26/06/2024 | Page: Scientific advice for veterinary medicines | Updated |
| 26/06/2024 | Document: General principles EMA-FDA parallel scientific advice (animal drug products) | New |
| 26/06/2024 | Document: EMA and FDA-CVM parallel scientific advice timetable | New |
| 26/06/2024 | Medicine: Ebvallo | Updated |
| 26/06/2024 | Medicine: HyQvia | Updated |
| 26/06/2024 | Medicine: Supemtek | Updated |
| 26/06/2024 | Medicine: Invanz | Updated |
| 26/06/2024 | Medicine: Agamree | Updated |
| 26/06/2024 | Document: Saxenda (liraglutide) supply shortage | Updated |
| 26/06/2024 | Document: Trulicity (dulaglutide) supply shortage | Updated |
| 26/06/2024 | Medicine: Lysodren | Updated |
| 26/06/2024 | Page: Website outages and upgrades | Updated |
| 25/06/2024 | Document: EVVet3 EVWeb Production – Release notes | Updated |
| 25/06/2024 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies | Updated |
| 25/06/2024 | Medicine: Exzolt | Updated |
| 25/06/2024 | Medicine: Zolvix | Updated |
| 25/06/2024 | Event: Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists | Updated |
| 25/06/2024 | Document: Agenda - Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists | Updated |
| 25/06/2024 | Medicine: Zercepac | Updated |
| 25/06/2024 | Medicine: Trocoxil | Updated |
| 25/06/2024 | Medicine: Neoclarityn | Updated |
| 25/06/2024 | Medicine: Bimzelx | Updated |
| 25/06/2024 | Medicine: Evicto | Updated |
| 25/06/2024 | Document: Agenda - PDCO agenda of the 25-28 June 2024 meeting | New |
| 25/06/2024 | Medicine: Semintra | Updated |
| 25/06/2024 | Medicine: Apoquel | Updated |
| 25/06/2024 | Document: Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance | New |
| 25/06/2024 | Document: Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance | New |
| 25/06/2024 | Medicine: Azomyr | Updated |
| 25/06/2024 | Medicine: Aerius | Updated |
| 25/06/2024 | Page: Annual reports and work programmes | Updated |
| 25/06/2024 | Medicine: Imatinib Accord | Updated |
| 25/06/2024 | Medicine: Finlee | Updated |
| 25/06/2024 | Medicine: Spexotras | Updated |
| 25/06/2024 | Document: Management Board meeting dates 2025-2026 | New |
| 25/06/2024 | Document: Outcome of written procedures finalised during the period from 12 March to 03 June 2024 | New |
| 25/06/2024 | Event: Webinar for industry and contract research organisations (CROs) on revised Environmental Risk Assessment (ERA) guideline for human medicinal products | New |
| 25/06/2024 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
| 25/06/2024 | Document: Overview of comments received on draft qualification opinion for Centiloid measure of Amyloid PET to quantify brain amyloid deposition | New |
| 25/06/2024 | Document: Qualification opinion for Centiloid measure of Amyloid PET to quantify brain amyloid deposition | New |
| 25/06/2024 | Document: Budesonide, prolonged release tablets, 9 mg product-specific bioequivalence guidance | New |
| 25/06/2024 | Document: Budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg product-specific bioequivalence guidance | New |
| 25/06/2024 | Document: Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance | New |
| 24/06/2024 | Medicine: Ocrevus | Updated |
| 24/06/2024 | Medicine: Jylamvo | Updated |
| 24/06/2024 | Medicine: Xaluprine (previously Mercaptopurine Nova Laboratories) | Updated |
| 24/06/2024 | Medicine: Jemperli | Updated |
| 24/06/2024 | Event: Ninth Industry Standing Group (ISG) meeting | New |
| 24/06/2024 | Medicine: Abecma | Updated |
| 24/06/2024 | Medicine: Constella | Updated |
| 24/06/2024 | Medicine: Piqray | Updated |
| 24/06/2024 | Medicine: Lutathera | Updated |
| 24/06/2024 | Document: Contractor SOP/MLM - WIN/MLM | Updated |
| 24/06/2024 | Medicine: Libtayo | Updated |
| 24/06/2024 | Event: First EMA-Animal Health Europe annual bilateral meeting | New |
| 24/06/2024 | Medicine: MenQuadfi | Updated |
| 21/06/2024 | Page: QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures - Species pictograms | Updated |
| 21/06/2024 | Post-authorisation: Stronghold Plus - opinion on variation to marketing authorisation | New |
| 21/06/2024 | Post-authorisation: Rabitec - opinion on variation to marketing authorisation | New |
| 21/06/2024 | Post-authorisation: Suvaxyn PRRS MLV - opinion on variation to marketing authorisation | New |
| 21/06/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024 | New |
| 21/06/2024 | Medicine: Divence IBR Marker Live | New |
| 21/06/2024 | Post-authorisation: Daxocox - opinion on variation to marketing authorisation | New |
| 21/06/2024 | Document: GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter) | Updated |
| 21/06/2024 | Document: List of centrally authorised products requiring a notification of a change for update of annexes | Updated |
| 21/06/2024 | Medicine: Sileo | Updated |
| 21/06/2024 | Document: Rules for the implementation of Council Regulation (EC) No 29795 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 May 2024 | New |
| 21/06/2024 | Document: Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests | New |
| 21/06/2024 | Event: New Fee Regulation: webinar for veterinary Marketing Authorisation Holders | Updated |
| 21/06/2024 | Medicine: Opdualag | Updated |
| 21/06/2024 | Medicine: Vafseo | Updated |
| 21/06/2024 | Medicine: Prialt | Updated |
| 21/06/2024 | Medicine: Triumeq | Updated |
| 21/06/2024 | Page: European Shortages Monitoring Platform | Updated |
| 21/06/2024 | Page: ICH M12 on drug interaction studies - Scientific guideline | Updated |
| 21/06/2024 | Event: Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
| 21/06/2024 | Page: Pre-authorisation guidance | Updated |
| 21/06/2024 | Page: Transfer of marketing authorisation: questions and answers | Updated |
| 21/06/2024 | Page: Changing the labelling and package leaflet (Article 61(3) notifications) | Updated |
| 21/06/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure | Updated |
| 21/06/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes | Updated |
| 21/06/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | Updated |
| 21/06/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes | Updated |
| 20/06/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - June 2024 | Updated |
| 20/06/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2024 | Updated |
| 20/06/2024 | Event: Multi-stakeholder workshop on Pharmacogenomics | New |
| 20/06/2024 | Medicine: Nintedanib Accord | Updated |
| 20/06/2024 | Medicine: Deferasirox Accord | Updated |
| 20/06/2024 | Medicine: Luxturna | Updated |
| 20/06/2024 | Document: Workplan 2023-2025: HMA-EMA joint Big Data Steering Group | Updated |
| 20/06/2024 | Medicine: Cubicin | Updated |
| 20/06/2024 | Medicine: Duloxetine Mylan | Updated |
| 20/06/2024 | Medicine: Tafinlar | Updated |
| 20/06/2024 | Medicine: Camcevi | Updated |
| 20/06/2024 | Medicine: Nilemdo | Updated |
| 20/06/2024 | Medicine: Nustendi | Updated |
| 20/06/2024 | Document: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when | Updated |
| 20/06/2024 | Event: EMA press briefing on EU actions to tackle shortages of GLP-1 receptor agonists | New |
| 20/06/2024 | Page: Patient registries | Updated |
| 20/06/2024 | Medicine: Dynastat | Updated |
| 20/06/2024 | Medicine: Brimica Genuair | Updated |
| 20/06/2024 | Medicine: Bretaris Genuair | Updated |
| 20/06/2024 | Medicine: Atosiban SUN | Updated |
| 20/06/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Krka | Updated |
| 19/06/2024 | Medicine: Lydisilka | Updated |
| 19/06/2024 | Medicine: Adynovi | Updated |
| 19/06/2024 | Medicine: Advate | Updated |
| 19/06/2024 | Medicine: Eviplera | Updated |
| 19/06/2024 | Medicine: Sondelbay | Updated |
| 19/06/2024 | Medicine: Alecensa | Updated |
| 19/06/2024 | Medicine: Xigduo | Updated |
| 19/06/2024 | Event: ACT EU consolidated advice pilots: information and training webinar for Applicants | New |
| 19/06/2024 | PSUSA: PSUSA/00002911/202310 - periodic safety update report single assessment | New |
| 19/06/2024 | Medicine: Firazyr | Updated |
| 19/06/2024 | PSUSA: PSUSA/00000438/202310 - periodic safety update report single assessment | New |
| 19/06/2024 | Medicine: Drovelis | Updated |
| 19/06/2024 | Medicine: Neoatricon | Updated |
| 19/06/2024 | DHPC: Zypadhera - direct healthcare professional communication (DHPC) | New |
| 18/06/2024 | PSUSA: PSUSA/00001321/202310 - periodic safety update report single assessment | New |
| 18/06/2024 | Medicine: Memantine Mylan | Updated |
| 18/06/2024 | Document: FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 | Updated |
| 18/06/2024 | Document: Step-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications - CTIS Training Programme - Module 10 | Updated |
| 18/06/2024 | Document: Roles and permissions matrix summary - Authority workspace - CTIS Training Programme - Module 07 | Updated |
| 18/06/2024 | Document: Clinical Trials Information System (CTIS) common features - CTIS Training Programme - Module 02 | Updated |
| 18/06/2024 | Document: Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11 | Updated |
| 18/06/2024 | Document: Checklist of required fields per application type - CTIS Training Programme - Module 10 | Updated |
| 18/06/2024 | PIP: EMEA-003376-PIP01-22 - paediatric investigation plan | New |
| 18/06/2024 | Event: Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS | Updated |
| 18/06/2024 | PIP: EMEA-003374-PIP01-22 - paediatric investigation plan | New |
| 18/06/2024 | PSUSA: PSUSA/00010891/202310 - periodic safety update report single assessment | New |
| 18/06/2024 | PIP: EMEA-003373-PIP01-22 - paediatric investigation plan | New |
| 18/06/2024 | PSUSA: PSUSA/00000783/202311 - periodic safety update report single assessment | New |
| 18/06/2024 | PIP: EMEA-003372-PIP01-22 - paediatric investigation plan | New |
| 18/06/2024 | Page: Medicine shortages and availability issues: guidance for companies | Updated |
| 18/06/2024 | Document: Medicine shortage mitigation plan - template | New |
| 18/06/2024 | Document: Medicine shortage prevention plan - template | New |
| 18/06/2024 | Document: Hearing the Association of the European Self-Medication Industry (AESGP) during the November 2023 Working Party meeting | New |
| 18/06/2024 | Event: Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries | Updated |
| 18/06/2024 | Document: Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa | Updated |
| 18/06/2024 | Event: Management Board meeting: 21 March 2024 | Updated |
| 18/06/2024 | Document: Minutes of the 123rd meeting of the Management Board on 21 March 2024 | New |
| 18/06/2024 | Medicine: Steqeyma | New |
| 18/06/2024 | Document: Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | New |
| 18/06/2024 | Event: Paediatric Committee (PDCO): 23-26 April 2024 | Updated |
| 18/06/2024 | Document: PDCO minutes of the 23-26 April 2024 meeting | New |
| 18/06/2024 | Herbal: Prunus avium peduncle - herbal medicinal product | Updated |
| 18/06/2024 | Document: Agenda of the COMP meeting 18-20 June 2024 | New |
| 18/06/2024 | News: Faster access to clinical trial information in Europe | New |
| 18/06/2024 | Page: Clinical Trials Information System: training and support | Updated |
| 18/06/2024 | Page: Clinical Trials Information System | Updated |
| 18/06/2024 | Page: Development of the Clinical Trials Information System | Updated |
| 18/06/2024 | Document: Appendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be audited | Updated |
| 18/06/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Request for information (RFI) | Updated |
| 18/06/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification | Updated |
| 18/06/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
| 17/06/2024 | Document: Agenda of the CVMP meeting 18-20 June 2024 | New |
| 17/06/2024 | Document: CTIS newsflash – 14 June 2024 | New |
| 17/06/2024 | Medicine: Lotimax | Updated |
| 17/06/2024 | Medicine: Lexylan | Updated |
| 17/06/2024 | PSUSA: PSUSA/00001453/202310 - periodic safety update report single assessment | New |
| 17/06/2024 | PSUSA: PSUSA/00001696/202311 - periodic safety update report single assessment | New |
| 17/06/2024 | PSUSA: PSUSA/00000696/202311 - periodic safety update report single assessment | New |
| 17/06/2024 | Medicine: Verzenios | Updated |
| 17/06/2024 | Medicine: Mounjaro | Updated |
| 17/06/2024 | Medicine: Trilorale | Updated |
| 17/06/2024 | Medicine: Invokana | Updated |
| 17/06/2024 | Medicine: Vokanamet | Updated |
| 17/06/2024 | Medicine: Trilocur | Updated |
| 17/06/2024 | Medicine: Wyost | Updated |
| 17/06/2024 | Medicine: Recocam | Updated |
| 17/06/2024 | Medicine: Forceris | Updated |
| 17/06/2024 | Medicine: Activyl | Updated |
| 17/06/2024 | Medicine: Bovilis Blue-8 | Updated |
| 17/06/2024 | Document: Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting | New |
| 17/06/2024 | Event: Small and medium-sized enterprises info day | New |
| 16/06/2024 | Event: Meeting of the Ad-hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024 | Updated |
| 14/06/2024 | Herbal: Tribuli terrestris herba - herbal medicinal product | Updated |
| 14/06/2024 | Document: Draft public statement on Tribulus terrestris L., herba - First version | New |
| 14/06/2024 | Herbal: Urticae radix - herbal medicinal product | Updated |
| 14/06/2024 | Herbal: Zingiberis rhizoma - herbal medicinal product | Updated |
| 14/06/2024 | Document: Draft European Union herbal monograph on Zingiber officinale Roscoe, rhizoma - Revision 1 | New |
| 14/06/2024 | Document: Annual activity report 2023 | New |
| 14/06/2024 | Herbal: Urticae herba - herbal medicinal product | Updated |
| 14/06/2024 | Medicine: Bavencio | Updated |
| 14/06/2024 | Document: Draft European Union herbal monograph on Urtica dioica L.; Urtica urens L., herba - Revision 1 | New |
| 14/06/2024 | Document: Draft European Union herbal monograph on Prunus avium L.; Prunus cerasus L., peduncle - First version | New |
| 14/06/2024 | Referral: Metamizole-containing medicinal products - referral | New |
| 14/06/2024 | News: Review of painkiller metamizole started | New |
| 14/06/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024 | New |
| 14/06/2024 | News: EMA Management Board: highlights of June 2024 meeting | New |
| 14/06/2024 | Document: Draft European Union herbal monograph on Urtica dioica L.; Urtica urens L., radix - Revision 1 | New |
| 14/06/2024 | Document: Draft list of references supporting the assessment of Urtica dioica L.; Urtica urens L., radix - Revision 1 | New |
| 14/06/2024 | Medicine: Nezglyal | Updated |
| 14/06/2024 | Medicine: Qalsody | New |
| 14/06/2024 | Medicine: Fabhalta | New |
| 14/06/2024 | Medicine: Kisqali | Updated |
| 14/06/2024 | Medicine: Opdivo | Updated |
| 14/06/2024 | Medicine: Tenkasi (previously Orbactiv) | Updated |
| 14/06/2024 | Event: Committee for Orphan Medicinal Products (COMP): 16-18 April 2024 | Updated |
| 14/06/2024 | Event: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meeting - April 2024 | Updated |
| 13/06/2024 | Event: Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
| 13/06/2024 | Document: Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
| 13/06/2024 | Medicine: Kalydeco | Updated |
| 13/06/2024 | Medicine: Suprelorin | Updated |
| 13/06/2024 | Medicine: Gumbohatch | Updated |
| 13/06/2024 | Medicine: Melovem | Updated |
| 13/06/2024 | Medicine: Vectra 3D | Updated |
| 13/06/2024 | Medicine: Simparica Trio | Updated |
| 13/06/2024 | Medicine: Coxevac | Updated |
| 13/06/2024 | Medicine: Nexgard Spectra | Updated |
| 13/06/2024 | Medicine: NexGard | Updated |
| 13/06/2024 | Medicine: Bluevac BTV (previously known as Bluevac BTV8) | Updated |
| 13/06/2024 | Document: Article 57 product data | Updated |
| 13/06/2024 | Document: Agenda of the 124th meeting of the Management Board : 12-13 June 2024 | New |
| 13/06/2024 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
| 13/06/2024 | Page: Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures | New |
| 13/06/2024 | Document: European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - track changes | New |
| 13/06/2024 | Document: Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures | New |
| 13/06/2024 | Document: European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - clean version | New |
| 13/06/2024 | Page: Union Product Database: release notes | Updated |
| 12/06/2024 | Page: Avian influenza (bird flu) | Updated |
| 12/06/2024 | Document: Agenda - Biannual Big Data Steering Group and industry stakeholders meeting 2024 | New |
| 12/06/2024 | Document: Summary report - - Biannual Big Data Steering Group and industry stakeholders meeting 2024 | New |
| 12/06/2024 | Page: Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 12/06/2024 | Document: Overview of (invented) names reviewed in April 2024 by the Name Review Group (NRG) adopted at the CHMP meeting of 27-30 May 2024 | New |
| 12/06/2024 | Document: Network Portfolio Roadmap | Updated |
| 12/06/2024 | Medicine: Xenpozyme | Updated |
| 12/06/2024 | Medicine: Ozempic | Updated |
| 12/06/2024 | Document: Minimum inhibitory concentration (MIC) breakpoints | Updated |
| 12/06/2024 | Medicine: Wegovy | Updated |
| 12/06/2024 | Event: Enpr-EMA Coordinating Group meeting June 2024 | New |
| 12/06/2024 | Event: Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices | Updated |
| 12/06/2024 | Medicine: Aubagio | Updated |
| 12/06/2024 | Medicine: Cervarix | Updated |
| 12/06/2024 | Medicine: Pedmarqsi | Updated |
| 12/06/2024 | Medicine: Opfolda | Updated |
| 12/06/2024 | Medicine: Comirnaty | Updated |
| 12/06/2024 | Document: HMPC: overview of assessment work - priority list | Updated |
| 12/06/2024 | Document: Minutes of the CAT meeting 17-19 January 2024 | Updated |
| 12/06/2024 | Document: Minutes of the PRAC meeting 8-11 April 2024 | New |
| 12/06/2024 | Document: Minutes of the CHMP meeting 18-21 March 2024 | New |
| 12/06/2024 | Document: CHMP PROM minutes for the meeting on 11 March 2024 | New |
| 12/06/2024 | Event: Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting | Updated |
| 12/06/2024 | Document: Meeting Summary - Medicine Shortages Single Point of Contact (SPOC) Working Party - 15-16 April 2024 | New |
| 12/06/2024 | PSUSA: PSUSA/00002607/202308 - periodic safety update report single assessment | New |
| 12/06/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 18-20 March 2024 | Updated |
| 12/06/2024 | Document: Minutes of the HMPC meeting 18-20 March 2024 | New |
| 12/06/2024 | Medicine: Imfinzi | Updated |
| 12/06/2024 | Medicine: Soliris | Updated |
| 12/06/2024 | Event: Fourth European Medicines Agency and Nuclear Medicines Europe bilateral meeting | New |
| 12/06/2024 | Event: Product Management Service (PMS) Product UI training (access & navigation) | Updated |
| 11/06/2024 | Medicine: Glyxambi | Updated |
| 11/06/2024 | Medicine: Credelio Plus | Updated |
| 11/06/2024 | Medicine: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) | Updated |
| 11/06/2024 | Medicine: Pyzchiva | Updated |
| 11/06/2024 | PSUSA: PSUSA/00001897/202308 - periodic safety update report single assessment | New |
| 11/06/2024 | PSUSA: PSUSA/00002125/202308 - periodic safety update report single assessment | New |
| 11/06/2024 | Event: Third listen-and-learn focus group meeting of the Quality Innovation Group | Updated |
| 11/06/2024 | Event: European Shortages Monitoring Platform Essentials and Industry Reporting Requirements | Updated |
| 11/06/2024 | Medicine: MiPet Easecto | Updated |
| 11/06/2024 | Medicine: Simparica | Updated |
| 11/06/2024 | Medicine: Hexyon | Updated |
| 11/06/2024 | Medicine: Hexacima | Updated |
| 11/06/2024 | Medicine: Veltassa | Updated |
| 11/06/2024 | Medicine: Litfulo | Updated |
| 11/06/2024 | Medicine: Improvac | Updated |
| 11/06/2024 | Medicine: Vumerity | Updated |
| 11/06/2024 | Referral: Micrazym and associated names - referral | Updated |
| 11/06/2024 | Medicine: Respivac TRT | Updated |
| 11/06/2024 | Medicine: Libmyris | Updated |
| 11/06/2024 | Medicine: Nuvaxovid | Updated |
| 10/06/2024 | Medicine: Respreeza | Updated |
| 10/06/2024 | Medicine: Zykadia | Updated |
| 10/06/2024 | Document: Agenda of the PRAC meeting 10-13 June 2024 | New |
| 10/06/2024 | Document: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level | Updated |
| 10/06/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 22 April 2024 | New |
| 10/06/2024 | Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
| 10/06/2024 | Medicine: Intuniv | Updated |
| 10/06/2024 | News: Two new advice pilots to improve clinical trials in Europe | New |
| 10/06/2024 | Document: Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars | Updated |
| 10/06/2024 | Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC | New |
| 10/06/2024 | Document: PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meeting | New |
| 10/06/2024 | Document: List of signals discussed at PRAC since September 2012 | Updated |
| 07/06/2024 | PIP: EMEA-003184-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003080-PIP03-22 - paediatric investigation plan | New |
| 07/06/2024 | Document: Change management activities delivery plan | New |
| 07/06/2024 | PIP: EMEA-002612-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003079-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | Orphan: EU/3/13/1199 - orphan designation for treatment of follicular thyroid cancer | Updated |
| 07/06/2024 | Orphan: EU/3/13/1200 - orphan designation for treatment of papillary thyroid cancer | Updated |
| 07/06/2024 | Medicine: Nexavar | Updated |
| 07/06/2024 | Medicine: Sylvant | Updated |
| 07/06/2024 | Orphan: EU/3/07/508 - orphan designation for treatment of Castleman's disease | Updated |
| 07/06/2024 | Medicine: Lamivudine Teva | Updated |
| 07/06/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 07/06/2024 | PIP: EMEA-000032-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | Medicine: Irbesartan/Hydrochlorothiazide Teva | Updated |
| 07/06/2024 | PIP: EMEA-003370-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003364-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003339-PIP02-23 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003302-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003279-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003251-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003208-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-001231-PIP02-13-M10 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001523-PIP04-19-M02 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001490-PIP01-13-M04 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001238-PIP03-21-M01 - paediatric investigation plan | Updated |
| 07/06/2024 | Medicine: Parsabiv | Updated |
| 07/06/2024 | Event: Methodology Working Party Interested Parties Meeting | New |
| 06/06/2024 | PIP: EMEA-001214-PIP09-21-M01 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-001194-PIP01-11-M06 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-001075-PIP04-15-M06 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000973-PIP01-10-M04 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000353-PIP02-16-M03 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000115-PIP01-07-M13 - paediatric investigation plan | Updated |
| 06/06/2024 | Medicine: Skyclarys | Updated |
| 06/06/2024 | Medicine: Rizmoic | Updated |
| 06/06/2024 | Medicine: Hizentra | Updated |
| 06/06/2024 | Medicine: Sitagliptin / Metformin hydrochloride Sun | Updated |
| 06/06/2024 | Medicine: Byfavo | Updated |
| 06/06/2024 | Medicine: Tysabri | Updated |
| 06/06/2024 | Medicine: Mimpara | Updated |
| 06/06/2024 | Medicine: Jubbonti | Updated |
| 06/06/2024 | Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animals | Updated |
| 06/06/2024 | Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) | Updated |
| 06/06/2024 | Medicine: Qdenga | Updated |
| 06/06/2024 | Page: Pharmacovigilance: Overview | Updated |
| 06/06/2024 | Document: Research projects conducted under the remit of the PRAC impact strategy | New |
| 06/06/2024 | PSUSA: PSUSA/00003043/202308 - periodic safety update report single assessment | New |
| 06/06/2024 | Medicine: Enbrel | Updated |
| 06/06/2024 | Medicine: Trodelvy | Updated |
| 06/06/2024 | Medicine: Myocet liposomal (previously Myocet) | Updated |
| 06/06/2024 | Medicine: Giapreza | Updated |
| 05/06/2024 | Page: Vaccine Monitoring Platform | Updated |
| 05/06/2024 | PSUSA: PSUSA/00003121/202308 - periodic safety update report single assessment | New |
| 05/06/2024 | DHPC: Kexxtone - direct healthcare professional communication (DHPC) | New |
| 05/06/2024 | Medicine: Reyataz | Updated |
| 05/06/2024 | Medicine: Erbitux | Updated |
| 05/06/2024 | Medicine: Beyfortus | Updated |
| 05/06/2024 | Medicine: PecFent | Updated |
| 05/06/2024 | Document: Salbutamol inhalation products suppy shortage | New |
| 05/06/2024 | Referral: Synapse - referral | Updated |
| 05/06/2024 | Referral: Ibuprofen NVT - referral | Updated |
| 05/06/2024 | Medicine: Alprolix | Updated |
| 05/06/2024 | Page: EudraVigilance training and support | Updated |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
| 05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Medicine: Abilify Maintena | Updated |
| 05/06/2024 | Page: PRIME: priority medicines | Updated |
| 05/06/2024 | Document: List of medicines currently in PRIME scheme | Updated |
| 05/06/2024 | Document: Application form for European Medicines Agency certificates of medicinal products | Updated |
| 04/06/2024 | Medicine: Xromi | Updated |
| 04/06/2024 | Document: Procedural advice on paediatric applications | Updated |
| 04/06/2024 | Medicine: Oxbryta | Updated |
| 04/06/2024 | Medicine: Onpattro | Updated |
| 04/06/2024 | Medicine: Suliqua | Updated |
| 04/06/2024 | Medicine: Xultophy | Updated |
| 04/06/2024 | PSUSA: PSUSA/00002114/202308 - periodic safety update report single assessment | New |
| 04/06/2024 | Document: Application form to request Simultaneous National Scientific Advice (SNSA) or a pre-CTA Advice | New |
| 04/06/2024 | Referral: Kexxtone 32.4 g continuous-release intraruminal device for cattle - referral | New |
| 03/06/2024 | Medicine: Credelio | Updated |
| 03/06/2024 | News: EU recommendations for 2024/2025 seasonal flu vaccine composition | Updated |
| 03/06/2024 | Document: 2023 annual report of the European Medicines Agency | Updated |
| 03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process | New |
| 03/06/2024 | Document: SNSA procedural flowchart | New |
| 03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content | New |
| 03/06/2024 | Document: SNSA – Involvement of NCAs | New |
| 03/06/2024 | Document: SNSA meeting minutes template for applicants | New |
| 03/06/2024 | Document: SNSA final advice report template | New |
| 03/06/2024 | Referral: Ocaliva - referral | Updated |
| 03/06/2024 | Page: Class waivers | Updated |
| 03/06/2024 | Page: Annual report on deferrals | Updated |
| 03/06/2024 | Page: Paediatric investigation plans | Updated |
| 03/06/2024 | Page: Paediatric investigation plans: questions and answers | Updated |
| 03/06/2024 | Page: Paediatric investigation plans: Templates and forms | Updated |
| 03/06/2024 | Page: Paediatric medicines: Overview | Updated |
| 03/06/2024 | Page: Paediatric medicines: Research and development | Updated |
| 03/06/2024 | Page: Paediatric medicines: applications and procedures | New |
| 03/06/2024 | Medicine: Xarelto | Updated |
| 03/06/2024 | Page: Information Management | Updated |
| 03/06/2024 | Document: Template - Request for compliance check on an agreed paediatric investigation plan (PIP) | Updated |
| 03/06/2024 | Medicine: Dacogen | Updated |
| 03/06/2024 | PIP: EMEA-003371-PIP01-22 - paediatric investigation plan | New |
| 03/06/2024 | Document: Template for scientific document | Updated |
| 03/06/2024 | Medicine: SomaKit TOC | Updated |
| 03/06/2024 | Medicine: Sunitinib Accord | Updated |
| 03/06/2024 | Medicine: Suboxone | Updated |
| 03/06/2024 | Medicine: Filspari | Updated |
| 03/06/2024 | Medicine: Circovac | Updated |
| 03/06/2024 | Medicine: Awiqli | Updated |
| 03/06/2024 | Page: Recommendations on medication errors | Updated |
| 03/06/2024 | Medicine: Bravecto | Updated |
| 03/06/2024 | Medicine: Imjudo | Updated |
| 03/06/2024 | Medicine: Bimervax | Updated |
| 03/06/2024 | Medicine: Cufence | Updated |
| 03/06/2024 | Medicine: Zilbrysq | Updated |
| 03/06/2024 | Medicine: Innovax-ND-H5 | Updated |
| 03/06/2024 | Medicine: Rozlytrek | Updated |
| 03/06/2024 | Medicine: Omlyclo | Updated |
| 03/06/2024 | Document: CTIS newsflash - 31 May 2024 | New |
| 03/06/2024 | Document: Shortage of human normal immunoglobulins | New |
| 03/06/2024 | Page: Removing an orphan designation | Updated |
