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