31/05/2024 | Medicine: Lytenava | Updated |
31/05/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS | Updated |
31/05/2024 | Medicine: Divence Tetra | Updated |
31/05/2024 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 6 June 2024 | New |
31/05/2024 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 27 June 2024 | New |
31/05/2024 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 13 June 2024 | New |
31/05/2024 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 20 June 2024 | New |
31/05/2024 | Medicine: Divence Penta | Updated |
31/05/2024 | Medicine: Enteroporc Coli | Updated |
31/05/2024 | Event: Eighth Industry Standing Group (ISG) meeting | Updated |
31/05/2024 | Event: Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists | New |
31/05/2024 | Document: User guide for micro, small and medium-sized enterprises | Updated |
31/05/2024 | Medicine: Meloxoral | Updated |
31/05/2024 | Medicine: Librela | Updated |
31/05/2024 | Post-authorisation: Dupixent - opinion on variation to marketing authorisation | New |
31/05/2024 | Medicine: Pomalidomide Krka | Updated |
31/05/2024 | Medicine: Kinharto | New |
31/05/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 | Updated |
31/05/2024 | Document: Minutes of the CVMP meeting 16-18 April 2024 | New |
31/05/2024 | Event: Cancer Medicines Forum workshop: April 2024 | Updated |
31/05/2024 | Referral: Mysimba - referral | Updated |
31/05/2024 | Medicine: Akantior | New |
31/05/2024 | Document: Questions and answers on the outcome of assessment to extend the use of Valdoxan (agomelatine) | New |
31/05/2024 | Post-authorisation: Scenesse - withdrawal of application for variation to marketing authorisation | New |
31/05/2024 | News: First vaccine to protect adults from Chikungunya | New |
31/05/2024 | Medicine: Dasatinib Accord Healthcare | New |
31/05/2024 | Post-authorisation: Tevimbra - opinion on variation to marketing authorisation | New |
31/05/2024 | Post-authorisation: Skyrizi - opinion on variation to marketing authorisation | New |
31/05/2024 | Medicine: Apexelsin | New |
31/05/2024 | Medicine: Adzynma | New |
31/05/2024 | Post-authorisation: Kinpeygo - opinion on variation to marketing authorisation | New |
31/05/2024 | Medicine: Zegalogue | New |
31/05/2024 | Medicine: Durveqtix | New |
31/05/2024 | Medicine: Pomalidomide Zentiva | New |
31/05/2024 | Medicine: Avzivi | New |
31/05/2024 | Medicine: Pomalidomide Accord | New |
31/05/2024 | Medicine: GalliaPharm | New |
31/05/2024 | Medicine: Cejemly | New |
31/05/2024 | Post-authorisation: Eliquis - opinion on variation to marketing authorisation | New |
31/05/2024 | Medicine: Ixchiq | New |
31/05/2024 | Post-authorisation: Tagrisso - opinion on variation to marketing authorisation | New |
31/05/2024 | Post-authorisation: Livmarli - opinion on variation to marketing authorisation | New |
31/05/2024 | Medicine: Fluenz | New |
31/05/2024 | Page: Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Scientific guideline | Updated |
31/05/2024 | News: New gene therapy treatment for haemophilia B | New |
31/05/2024 | Page: Frequently asked questions about parallel distribution | Updated |
31/05/2024 | Document: Checklist for initial notifications for parallel distribution: guidance for industry | Updated |
31/05/2024 | Document: Checklist for annual updates for parallel distribution: guidance for industry | Updated |
31/05/2024 | Document: Frequently asked questions about parallel distribution | Updated |
30/05/2024 | Medicine: Tecartus | Updated |
30/05/2024 | Medicine: Baqsimi | Updated |
30/05/2024 | Page: Scientific publications | Updated |
30/05/2024 | Medicine: Kapruvia | Updated |
30/05/2024 | Medicine: Avamys | Updated |
30/05/2024 | PIP: EMEA-003104-PIP02-22 - paediatric investigation plan | New |
30/05/2024 | PIP: EMEA-003063-PIP02-22 - paediatric investigation plan | New |
30/05/2024 | PIP: EMEA-003024-PIP01-21 - paediatric investigation plan | New |
30/05/2024 | PIP: EMEA-002559-PIP07-22 - paediatric investigation plan | New |
30/05/2024 | Medicine: Orgalutran | Updated |
30/05/2024 | News: Annual report highlights progress in science, medicines and health in 2023 | New |
30/05/2024 | Page: Annual reports and work programmes | Updated |
30/05/2024 | Document: Annexes - 2023 annual report of the European Medicines Agency | New |
30/05/2024 | Document: Annex 10 - 2023 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication | New |
30/05/2024 | PSUSA: PSUSA/00000996/202308 - periodic safety update report single assessment | New |
30/05/2024 | Event: European Medicines Agency (EMA) Healthcare Professionals' (HCPWP) Working Party meeting | New |
30/05/2024 | Page: Patients' and Consumers' Working Party | Updated |
30/05/2024 | Page: ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline | New |
30/05/2024 | Document: ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b | New |
29/05/2024 | Event: EU NTC ten year anniversary event | Updated |
29/05/2024 | Referral: Procaine benzylpenicillin - referral | Updated |
29/05/2024 | Medicine: Yescarta | Updated |
29/05/2024 | Medicine: Mounjaro | Updated |
29/05/2024 | Medicine: Nimenrix | Updated |
29/05/2024 | Medicine: Voriconazole Hikma (previously Voriconazole Hospira) | Updated |
29/05/2024 | Medicine: Jyseleca | Updated |
29/05/2024 | Medicine: Zessly | Updated |
29/05/2024 | Medicine: Isturisa | Updated |
29/05/2024 | Medicine: Advate | Updated |
29/05/2024 | Medicine: Vyepti | Updated |
29/05/2024 | Document: Annex XV - List of topiramate containing medicinal products in the European Union | New |
29/05/2024 | Page: List of medicines under additional monitoring | Updated |
29/05/2024 | Document: Annex XV - List of topiramate containing medicinal products in the European Union | New |
29/05/2024 | Document: List of medicinal products under additional monitoring | Updated |
29/05/2024 | Document: List of medicinal products under additional monitoring | Updated |
29/05/2024 | Medicine: Rixubis | Updated |
29/05/2024 | Medicine: Dzuveo | Updated |
29/05/2024 | Medicine: Hemlibra | Updated |
29/05/2024 | Medicine: Dynastat | Updated |
29/05/2024 | Page: National registers of authorised medicines | Updated |
29/05/2024 | Medicine: Zolsketil pegylated liposomal | Updated |
29/05/2024 | Document: EU 4 AMA: leveraging European expertise for medicines regulation in Africa | New |
28/05/2024 | PIP: EMEA-002427-PIP01-18-M02 - paediatric investigation plan | Updated |
28/05/2024 | Medicine: Zoonotic Influenza Vaccine Seqirus | Updated |
28/05/2024 | PIP: EMEA-002246-PIP01-17-M03 - paediatric investigation plan | Updated |
28/05/2024 | PSUSA: PSUSA/00001642/202309 - periodic safety update report single assessment | New |
28/05/2024 | PIP: EMEA-002233-PIP01-17-M02 - paediatric investigation plan | Updated |
28/05/2024 | PIP: EMEA-002166-PIP01-17-M07 - paediatric investigation plan | Updated |
28/05/2024 | PIP: EMEA-001679-PIP01-14-M03 - paediatric investigation plan | Updated |
28/05/2024 | PIP: EMEA-001652-PIP01-14-M05 - paediatric investigation plan | Updated |
28/05/2024 | Medicine: Truvada | Updated |
28/05/2024 | Page: Clinical Trials Information System: training and support | Updated |
28/05/2024 | Medicine: Reagila | Updated |
28/05/2024 | Document: Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP | New |
28/05/2024 | Event: Clinical Trials Information System (CTIS) sponsor end user training programme - November 2024 | New |
28/05/2024 | Event: Clinical Trials Information System (CTIS) sponsor end user training programme - October 2024 | New |
28/05/2024 | Medicine: Sarclisa | Updated |
28/05/2024 | Event: Clinical Trials Information System (CTIS) sponsor end user training programme - September 2024 | New |
28/05/2024 | Medicine: Filgrastim Hexal | Updated |
28/05/2024 | Event: Paediatric Committee (PDCO): 28-31 May 2024 | Updated |
28/05/2024 | Document: Agenda - PDCO agenda of the 28-31 May 2024 meeting | New |
28/05/2024 | Page: Data Analysis and Real World Interrogation Network (DARWIN EU) | Updated |
28/05/2024 | Event: DARWIN EU Advisory Board meeting: 3 May 2024 | New |
28/05/2024 | Document: DARWIN EU Advisory Board: Membership | Updated |
28/05/2024 | Event: DARWIN EU Advisory Board meeting - 11 December 2023 | Updated |
28/05/2024 | Document: Careers at EMA user-guide | Updated |
28/05/2024 | Medicine: Zarzio | Updated |
28/05/2024 | Medicine: Retsevmo | Updated |
28/05/2024 | Medicine: Betmiga | Updated |
28/05/2024 | Medicine: Nuceiva | Updated |
27/05/2024 | Medicine: Loargys | Updated |
27/05/2024 | Document: Agenda of the CHMP meeting 27-30 May 2024 | New |
27/05/2024 | Medicine: Vectormune FP ILT | Updated |
27/05/2024 | Medicine: Ronapreve | Updated |
27/05/2024 | Medicine: Rotarix | Updated |
24/05/2024 | Medicine: Sotyktu | Updated |
24/05/2024 | Medicine: Tenofovir disoproxil Zentiva | Updated |
24/05/2024 | Medicine: Vyvgart | Updated |
24/05/2024 | Medicine: Rinvoq | Updated |
24/05/2024 | Medicine: Vyxeos liposomal (previously known as Vyxeos) | Updated |
24/05/2024 | Medicine: Saphnelo | Updated |
24/05/2024 | Medicine: Nexviadyme | Updated |
24/05/2024 | Medicine: Benlysta | Updated |
24/05/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024 | Updated |
24/05/2024 | Medicine: Orserdu | Updated |
24/05/2024 | Medicine: Skyrizi | Updated |
24/05/2024 | Medicine: TachoSil | Updated |
24/05/2024 | Medicine: Locametz | Updated |
24/05/2024 | Medicine: Sprycel | Updated |
24/05/2024 | Page: Support for industry on clinical data publication | Updated |
24/05/2024 | Document: Anonymisation report form instructions | New |
24/05/2024 | Document: Anonymisation report form template | New |
24/05/2024 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
24/05/2024 | Post-authorisation: Bluevac BTV (previously known as Bluevac BTV8) - opinion on variation to marketing authorisation | New |
24/05/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm | New |
24/05/2024 | Medicine: Nobilis Multriva RT+IBm+ND+EDS | New |
24/05/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024 | New |
24/05/2024 | Medicine: Darunavir Viatris (previously Darunavir Mylan) | Updated |
24/05/2024 | Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions | Updated |
24/05/2024 | Document: List of centrally authorised products requiring a notification of a change for update of annexes | Updated |
24/05/2024 | Page: Industry annual bilateral meetings | Updated |
24/05/2024 | Event: Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting | New |
24/05/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2024 | Updated |
23/05/2024 | Medicine: Binocrit | Updated |
23/05/2024 | Medicine: Epoetin Alfa Hexal | Updated |
23/05/2024 | Medicine: Abseamed | Updated |
23/05/2024 | Medicine: Spravato | Updated |
23/05/2024 | Medicine: Tizveni | Updated |
23/05/2024 | Event: Environmental Risk Assessment (ERA) Assessors Training | New |
23/05/2024 | Medicine: Strangvac | Updated |
23/05/2024 | Page: SME Regulation and reports | Updated |
23/05/2024 | Medicine: Lumykras | Updated |
23/05/2024 | Medicine: Arexvy | Updated |
23/05/2024 | Herbal: Rhodiolae roseae rhizoma et radix - herbal medicinal product | Updated |
23/05/2024 | Medicine: LysaKare | Updated |
23/05/2024 | Medicine: Zonisamide Mylan | Updated |
23/05/2024 | Medicine: Enerzair Breezhaler | Updated |
23/05/2024 | Medicine: Loxitab | Updated |
23/05/2024 | DHPC: Giapreza - direct healthcare professional communication (DHPC) | New |
23/05/2024 | Medicine: Eluracat | Updated |
23/05/2024 | Medicine: Oxmax | Updated |
23/05/2024 | Medicine: Atectura Breezhaler | Updated |
23/05/2024 | Medicine: Cerezyme | Updated |
22/05/2024 | Medicine: Ibrance | Updated |
22/05/2024 | Medicine: Nubeqa | Updated |
22/05/2024 | Medicine: Imvanex | Updated |
22/05/2024 | Medicine: Flixabi | Updated |
22/05/2024 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
22/05/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - September 2024 | New |
22/05/2024 | Document: EVVet3 EVWeb Production – Release notes | Updated |
22/05/2024 | Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7 | Updated |
22/05/2024 | Medicine: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) | Updated |
22/05/2024 | Medicine: Amgevita | Updated |
22/05/2024 | Medicine: Krazati | Updated |
22/05/2024 | Medicine: Tevimbra | Updated |
22/05/2024 | Medicine: Spexotras | Updated |
22/05/2024 | Medicine: Roclanda | Updated |
22/05/2024 | Medicine: Stayveer | Updated |
22/05/2024 | Medicine: Fulvestrant Mylan | Updated |
22/05/2024 | Medicine: Mekinist | Updated |
22/05/2024 | Document: Agenda of the CAT meeting 22-24 May 2024 | New |
22/05/2024 | Medicine: Viagra | Updated |
21/05/2024 | PIP: EMEA-003273-PIP02-22 - paediatric investigation plan | New |
21/05/2024 | PSUSA: PSUSA/00000958/202309 - periodic safety update report single assessment | New |
21/05/2024 | PIP: EMEA-003090-PIP02-22 - paediatric investigation plan | New |
21/05/2024 | PIP: EMEA-003355-PIP01-22 - paediatric investigation plan | New |
21/05/2024 | Medicine: Tafinlar | Updated |
21/05/2024 | PIP: EMEA-002247-PIP03-17-M01 - paediatric investigation plan | Updated |
21/05/2024 | Medicine: Finlee | Updated |
21/05/2024 | Medicine: Tecentriq | Updated |
21/05/2024 | Medicine: Quviviq | Updated |
21/05/2024 | Medicine: Erleada | Updated |
21/05/2024 | Medicine: Tepmetko | Updated |
21/05/2024 | Medicine: Palonosetron Accord | Updated |
21/05/2024 | News: EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna | Updated |
21/05/2024 | News: Medical devices: new guidance for industry and notified bodies | New |
21/05/2024 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) | Updated |
21/05/2024 | Medicine: Mysildecard | Updated |
21/05/2024 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes | Updated |
21/05/2024 | Medicine: Apremilast Accord | Updated |
21/05/2024 | Document: CTIS newsflash - 17 May 2024 | New |
21/05/2024 | Medicine: Cresemba | Updated |
21/05/2024 | Medicine: Temozolomide Sun | Updated |
21/05/2024 | Document: Agenda of the CVMP meeting 21-23 May 2024 | New |
21/05/2024 | Document: Agenda of the COMP meeting 21-23 May 2024 | New |
21/05/2024 | Medicine: Evenity | Updated |
21/05/2024 | Medicine: Rekambys | Updated |
21/05/2024 | News: Have your say and help shape EMA’s future communications | New |
20/05/2024 | News: European medicines network designated as WHO listed authority | New |
17/05/2024 | PSUSA: PSUSA/00010768/202310 - periodic safety update report single assessment | New |
17/05/2024 | Medicine: Trepulmix | Updated |
17/05/2024 | Medicine: Ajovy | Updated |
17/05/2024 | Medicine: Voydeya | Updated |
17/05/2024 | Event: Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal | New |
17/05/2024 | Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services | Updated |
17/05/2024 | Medicine: Onivyde pegylated liposomal (previously known as Onivyde) | Updated |
17/05/2024 | Page: Outcomes of imposed non-interventional post-authorisation safety studies | Updated |
17/05/2024 | Document: European Medicines Agency’s data protection notice for the EMA Help Desk | Updated |
17/05/2024 | Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1 | Updated |
17/05/2024 | Medicine: Miglustat Gen.Orph | Updated |
17/05/2024 | News: Hydroxyprogesterone caproate medicines to be suspended from the EU market | New |
17/05/2024 | Referral: Hydroxyprogesterone caproate-containing medicinal products - referral | Updated |
17/05/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 | New |
17/05/2024 | Medicine: Tracleer | Updated |
17/05/2024 | Medicine: Zepatier | Updated |
16/05/2024 | PSUSA: PSUSA/00002569/202309 - periodic safety update report single assessment | New |
16/05/2024 | PSUSA: PSUSA/00000034/202309 - periodic safety update report single assessment | New |
16/05/2024 | PSUSA: PSUSA/00010806/202310 - periodic safety update report single assessment | New |
16/05/2024 | Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 | New |
16/05/2024 | Medicine: Nplate | Updated |
16/05/2024 | Medicine: Kalydeco | Updated |
16/05/2024 | Medicine: Temozolomide Teva | Updated |
16/05/2024 | Document: PDCO minutes of the 19-22 March 2024 meeting | New |
16/05/2024 | News: EMA closed on Whit Monday, 20 May | New |
16/05/2024 | Medicine: Colobreathe | Updated |
16/05/2024 | Medicine: Fingolimod Accord | Updated |
16/05/2024 | Document: Meeting Summary of the Medicine Shortages (SPOC) Working Party - 14 March 2024 | New |
16/05/2024 | Document: Agenda - Medicine Shortages (SPOC) Working Party 14 March 2024 | New |
16/05/2024 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
16/05/2024 | Document: Records of data processing activity for study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period” | New |
16/05/2024 | Event: EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework | Updated |
16/05/2024 | Document: EudraVigilance registration documents | Updated |
16/05/2024 | Document: EudraVigilance Form A | Updated |
16/05/2024 | Document: New Organization First User QPPV/RP or Change of EU QPPV/RP | Updated |
16/05/2024 | Document: European Medicines Agency's data protection notice on the study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period” | New |
16/05/2024 | Medicine: Pregabalin Sandoz | Updated |
16/05/2024 | Page: Network Portfolio | Updated |
16/05/2024 | Medicine: Pregabalin Mylan | Updated |
16/05/2024 | Document: Organisation chart: Information Management | Updated |
16/05/2024 | Medicine: Ibuprofen Gen.Orph | Updated |
15/05/2024 | Medicine: Brukinsa | Updated |
15/05/2024 | Document: Policy 78: EMA environmental policy | Updated |
15/05/2024 | Medicine: Tasigna | Updated |
15/05/2024 | Medicine: Ryzneuta | Updated |
15/05/2024 | Medicine: Imcivree | Updated |
15/05/2024 | Medicine: Neuraceq | Updated |
15/05/2024 | Medicine: Lyrica | Updated |
15/05/2024 | Medicine: Kaftrio | Updated |
15/05/2024 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
15/05/2024 | Medicine: Uptravi | Updated |
14/05/2024 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2024 | Updated |
14/05/2024 | Document: Agenda of the PRAC meeting 13-16 May 2024 | Updated |
14/05/2024 | Document: Guidebook for tenderers | Updated |
14/05/2024 | Document: Article 57 product data | Updated |
14/05/2024 | Medicine: Thalidomide Lipomed | Updated |
14/05/2024 | Medicine: Mayzent | Updated |
14/05/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - July 2024 | Updated |
14/05/2024 | Medicine: Olanzapine Mylan | Updated |
14/05/2024 | Document: Minutes of the PRAC meeting 4-7 March 2024 | New |
14/05/2024 | Medicine: Vegzelma | Updated |
14/05/2024 | Medicine: Poteligeo | Updated |
14/05/2024 | Medicine: Aspaveli | Updated |
14/05/2024 | Document: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide | Updated |
13/05/2024 | Medicine: GONAL-f | Updated |
13/05/2024 | Medicine: Agamree | Updated |
13/05/2024 | Medicine: Axumin | Updated |
13/05/2024 | Medicine: Bexsero | Updated |
13/05/2024 | Medicine: Ghryvelin (previously Macimorelin Aeterna Zentaris) | Updated |
13/05/2024 | Medicine: Scenesse | Updated |
13/05/2024 | Medicine: Anagrelide Viatris (previously Anagrelide Mylan) | Updated |
13/05/2024 | Medicine: Myozyme | Updated |
13/05/2024 | Medicine: Fabrazyme | Updated |
13/05/2024 | Medicine: Kauliv | Updated |
13/05/2024 | Medicine: Onglyza | Updated |
13/05/2024 | Medicine: Rasagiline Mylan | Updated |
13/05/2024 | Medicine: Plerixafor Accord | Updated |
13/05/2024 | Medicine: Atriance | Updated |
13/05/2024 | Medicine: Spinraza | Updated |
13/05/2024 | Medicine: Granupas (previously Para-aminosalicylic acid Lucane) | Updated |
13/05/2024 | Medicine: Vyndaqel | Updated |
13/05/2024 | Medicine: Dupixent | Updated |
13/05/2024 | Medicine: Telmisartan Actavis | Updated |
13/05/2024 | Medicine: Luxturna | Updated |
13/05/2024 | Medicine: Leqvio | Updated |
13/05/2024 | Medicine: Heplisav B | Updated |
13/05/2024 | Medicine: Orkambi | Updated |
13/05/2024 | Medicine: Reblozyl | Updated |
13/05/2024 | Medicine: Abrysvo | Updated |
13/05/2024 | Medicine: Keytruda | Updated |
13/05/2024 | Medicine: Tresiba | Updated |
13/05/2024 | Medicine: Isentress | Updated |
13/05/2024 | Medicine: Ryzodeg | Updated |
08/05/2024 | Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 | Updated |
08/05/2024 | Document: Timetable: Post-authorisation safety study (PASS) protocols and final results | Updated |
08/05/2024 | Document: Timetable: Initial (Full) marketing authorisation application - ATMP | Updated |
07/05/2024 | Document: Organisation chart: Advisory functions | Updated |
07/05/2024 | Page: Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guideline | Updated |
07/05/2024 | Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Updated |
07/05/2024 | Herbal: Hippocastani cortex - herbal medicinal product | Updated |
07/05/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 | Updated |
07/05/2024 | News: EMA closed 9-10 May | New |
07/05/2024 | Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa" | New |
07/05/2024 | Medicine: Emblaveo | Updated |
07/05/2024 | News: One Health: a joint framework for action published by five EU agencies | New |
07/05/2024 | Event: Product Management Service (PMS) Info-Day | Updated |
07/05/2024 | Page: COVID-19 vaccines: key facts | Updated |
06/05/2024 | Document: Record of data processing activity relating to Security Access Control System | Updated |
06/05/2024 | Document: Records of data processing activity for audiovisual tool for checking presence in meeting rooms | New |
06/05/2024 | Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control System | Updated |
06/05/2024 | Document: European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting rooms | New |
06/05/2024 | Page: Procurement | Updated |
06/05/2024 | Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
06/05/2024 | PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessment | New |
06/05/2024 | Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma Workshop | New |
06/05/2024 | Document: Minutes of the COMP meeting 12-14 March 2024 | New |
06/05/2024 | Medicine: Adynovi | Updated |
06/05/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
06/05/2024 | Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meeting | New |
03/05/2024 | Medicine: MenQuadfi | Updated |
03/05/2024 | PIP: EMEA-002754-PIP01-19 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-002693-PIP01-19 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-003157-PIP01-21 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-001666-PIP01-14-M01 - paediatric investigation plan | Updated |
03/05/2024 | Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
03/05/2024 | Event: Third European Medicines Agency and Affordable Medicines Europe bilateral meeting | Updated |
03/05/2024 | PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessment | New |
03/05/2024 | Medicine: Briumvi | Updated |
03/05/2024 | Document: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23 | Updated |
03/05/2024 | Medicine: Sivextro | Updated |
03/05/2024 | Medicine: Talzenna | Updated |
03/05/2024 | Page: ICH M10 on bioanalytical method validation - Scientific guideline | Updated |
03/05/2024 | Page: Real-world evidence | New |
03/05/2024 | Page: Big data | Updated |
03/05/2024 | Page: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline | New |
03/05/2024 | Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence | New |
02/05/2024 | Event: CVMP Interested Parties’ meeting | New |
02/05/2024 | Document: Scientific recommendations on classification of advanced therapy medicinal products | Updated |
02/05/2024 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
02/05/2024 | Herbal: Malvae sylvestris flos - herbal medicinal product | Updated |
02/05/2024 | Medicine: Pelmeg | Updated |
02/05/2024 | Medicine: Noxafil | Updated |
02/05/2024 | Medicine: Teriflunomide Accord | Updated |
02/05/2024 | Medicine: Byooviz | Updated |
02/05/2024 | Medicine: Pluvicto | Updated |
02/05/2024 | Medicine: RotaTeq | Updated |
02/05/2024 | Medicine: Volibris | Updated |
02/05/2024 | Herbal: Malvae folium - herbal medicinal product | Updated |
02/05/2024 | Medicine: Vafseo | Updated |
02/05/2024 | Medicine: Incellipan | Updated |
02/05/2024 | Page: Handling competing interests | Updated |
02/05/2024 | Medicine: Celldemic | Updated |
02/05/2024 | Medicine: Zynyz | Updated |
02/05/2024 | Document: CAT quarterly highlights and approved ATMPs - February - April 2024 | New |
02/05/2024 | Page: Quality of medicines questions and answers: Part 1 | Updated |
02/05/2024 | Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline | Updated |
02/05/2024 | Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products | New |
02/05/2024 | Medicine: Mirapexin | Updated |
02/05/2024 | Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling | New |
02/05/2024 | Document: List of eligible industry stakeholder organisations | Updated |