DateContentStatus
20/11/2024 Medicine: Tenkasi (previously Orbactiv)Updated
20/11/2024 Medicine: MycamineUpdated
20/11/2024 PIP: EMEA-001741-PIP09-23 - paediatric investigation planNew
20/11/2024 PIP: EMEA-001741-PIP08-22 - paediatric investigation planNew
20/11/2024 PIP: EMEA-003379-PIP01-22 - paediatric investigation planNew
20/11/2024 PIP: EMEA-002705-PIP05-23 - paediatric investigation planNew
20/11/2024 PIP: EMEA-003307-PIP01-22 - paediatric investigation planNew
20/11/2024 PIP: EMEA-001521-PIP03-22 - paediatric investigation planNew
20/11/2024 PIP: EMEA-003363-PIP01-22 - paediatric investigation planNew
20/11/2024 PIP: EMEA-003033-PIP02-22 - paediatric investigation planNew
20/11/2024 Orphan: EU/3/24/2986 - orphan designation for treatment of amyotrophic lateral sclerosisNew
20/11/2024 Orphan: EU/3/24/2979 - orphan designation for treatment of hereditary angioedemaNew
20/11/2024 Orphan: EU/3/24/2982 - orphan designation for treatment of retinoblastomaNew
20/11/2024 Document: QRD Appendix I - Adverse event (PhV) MSs reporting detailsUpdated
20/11/2024 Orphan: EU/3/24/2981 - orphan designation for treatment of frontotemporal dementiaNew
20/11/2024 Document: Network Portfolio RoadmapUpdated
20/11/2024 Orphan: EU/3/24/2978 - orphan designation for treatment of chondrosarcomaNew
20/11/2024 Document: Minutes of the COMP meeting 08-10 October 2024New
20/11/2024 Document: Draft concept paper on the European Platform for Regulatory Science ResearchUpdated
20/11/2024 Document: Draft Regulatory Science Research Needs - 2024 updateUpdated
20/11/2024 Document: Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))Updated
20/11/2024 Orphan: EU/3/24/2985 - orphan designation for treatment of primary IgA nephropathyNew
20/11/2024 Medicine: KalydecoUpdated
20/11/2024 Orphan: EU/3/24/2987 - orphan designation for treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease)New
20/11/2024 Orphan: EU/3/24/2976 - orphan designation for treatment of cystic fibrosisNew
20/11/2024 Orphan: EU/3/24/2983 - orphan designation for treatment of cutaneous T-cell lymphomaNew
20/11/2024 Document: Social Media Data for Real World Evidence in Regulatory Decision MakingUpdated
20/11/2024 Page: ProcurementUpdated
20/11/2024 Document: CTIS newsflash - 19 November 2024New
20/11/2024 Page: Medical devicesUpdated
20/11/2024 Document: Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on from the Expert PanelsNew
20/11/2024 Document: Template - Request for advice on the orphan device status pursuant to Article 61(2) of Regulation (EU) 2017/745 and MDCG 2024-10New
20/11/2024 Medicine: JinarcUpdated
20/11/2024 Medicine: NezglyalUpdated
20/11/2024 Event: Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS)Updated
20/11/2024 Document: Agenda - Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS)New
20/11/2024 Medicine: KisqaliUpdated
20/11/2024 Medicine: IbranceUpdated
20/11/2024 Post-authorisation: Inaqovi - withdrawal of application for variation to marketing authorisationUpdated
20/11/2024 Document: Agenda of the HMPC meeting 18-20 November 2024New
20/11/2024 Post-authorisation: Keytruda - opinion on variation to marketing authorisationUpdated
20/11/2024 Medicine: ElfabrioUpdated
20/11/2024 Medicine: KeytrudaUpdated
20/11/2024 Event: Fifth EMA/HMA Big Data Stakeholder ForumUpdated
20/11/2024 Medicine: FluenzUpdated
19/11/2024 Page: European Shortages Monitoring PlatformUpdated
19/11/2024 Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holdersNew
19/11/2024 PIP: EMEA-003446-PIP01-23 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003362-PIP01-22 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003452-PIP01-23 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003368-PIP01-22 - paediatric investigation planNew
19/11/2024 PIP: EMEA-002830-PIP01-20 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003449-PIP01-23 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003450-PIP01-23 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003347-PIP01-22 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003461-PIP01-23 - paediatric investigation planNew
19/11/2024 PIP: EMEA-003456-PIP01-23 - paediatric investigation planNew
19/11/2024 Medicine: OrdsponoUpdated
19/11/2024 Page: Plasma master file certificatesUpdated
19/11/2024 Orphan: EU/3/14/1360 - orphan designation for treatment of haemophilia AUpdated
19/11/2024 Orphan: EU/3/24/2988 - orphan designation for treatment of gliomaNew
19/11/2024 Orphan: EU/3/24/2991 - orphan designation for treatment of ATTR amyloidosisNew
19/11/2024 Orphan: EU/3/24/2990 - orphan designation for treatment of spinal cord injuryNew
19/11/2024 Orphan: EU/3/21/2440 - orphan designation for treatment of X-linked severe combined immunodeficiencyUpdated
19/11/2024 Orphan: EU/3/21/2546 - orphan designation for treatment of acute lymphoblastic leukaemiaUpdated
19/11/2024 Orphan: EU/3/20/2362 - orphan designation for treatment of X-linked severe combined immunodeficiencyUpdated
19/11/2024 Orphan: EU/3/23/2866 - orphan designation for treatment of haemophilia BUpdated
19/11/2024 Orphan: EU/3/20/2293 - orphan designation for treatment of Becker muscular dystrophyUpdated
19/11/2024 Orphan: EU/3/22/2677 - orphan designation for treatment of haemophilia AUpdated
19/11/2024 Orphan: EU/3/24/2977 - orphan designation for treatment of pancreatic cancerNew
19/11/2024 Orphan: EU/3/24/2984 - orphan designation for treatment of autosomal dominant polycystic liver diseaseNew
19/11/2024 Page: Nitrosamine impuritiesUpdated
19/11/2024 Page: Scientific review on the risk of nitrosamine impurities in human medicines New
19/11/2024 Page: Nitrosamine impurities: guidance for marketing authorisation holdersNew
19/11/2024 Page: Nitrosamine impurities in specific medicinesNew
19/11/2024 Orphan: EU/3/17/1868 - orphan designation for treatment of fragile X syndromeUpdated
19/11/2024 Medicine: KymriahUpdated
19/11/2024 Orphan: EU/3/15/1602 - orphan designation for treatment of anal cancerUpdated
19/11/2024 Orphan: EU/3/19/2234 - orphan designation for treatment of Duchenne muscular dystrophyUpdated
19/11/2024 Medicine: JayempiUpdated
18/11/2024 Event: UPD refresher webinar for marketing authorisation holders on volume of sales submissionNew
18/11/2024 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 requestsUpdated
18/11/2024 Medicine: PylclariUpdated
18/11/2024 Page: Clinical Trials Information System (CTIS): training and supportUpdated
18/11/2024 Medicine: GanfortUpdated
18/11/2024 Medicine: LumiganUpdated
18/11/2024 Document: VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens – gallus gallus (Revision 1)New
18/11/2024 Document: VICH GL20 Efficacy of anthelmintics: specific recommendations for felines (Revision 1)New
18/11/2024 Document: VICH GL19 Efficacy of anthelmintics: specific recommendations for canines (Revision 1)New
18/11/2024 Document: VICH GL16 Efficacy of anthelmintics: specific recommendations for porcines (Revision 1)New
18/11/2024 Document: VICH GL15 Efficacy of anthelmintics: specific recommendations for equines (Revision 1)New
18/11/2024 Document: VICH GL14 Efficacy of anthelmintics: specific recommendations for caprines (Revision 1)New
18/11/2024 Document: VICH GL13 Efficacy of anthelmintics: specific recommendations for ovines (Revision 1)New
18/11/2024 Document: VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines (Revision 1)New
18/11/2024 Document: VICH GL7 Efficacy of anthelmintics: general requirements - Revision 1New
18/11/2024 Page: Antimicrobial resistanceUpdated
18/11/2024 Document: Antimicrobial resistance: A call to action against the silent pandemicNew
18/11/2024 Document: Agenda - HMA-EMA Big Data Stakeholder Forum 2024Updated
18/11/2024 Page: Extended EudraVigilance medicinal product dictionary (XEVMPD) trainingUpdated
18/11/2024 Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February 2025New
18/11/2024 Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - June 2025New
18/11/2024 Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - May 2025New
18/11/2024 Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - March 2025New
18/11/2024 Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - April 2025New
18/11/2024 Medicine: MenQuadfiUpdated
15/11/2024 Event: Eleventh Industry Standing Group (ISG) meetingNew
15/11/2024 PIP: EMEA-003025-PIP03-23 - paediatric investigation planNew
15/11/2024 PIP: EMEA-003455-PIP01-23 - paediatric investigation planNew
15/11/2024 PIP: EMEA-003063-PIP03-22 - paediatric investigation planNew
15/11/2024 PIP: EMEA-003321-PIP01-22 - paediatric investigation planNew
15/11/2024 PIP: EMEA-002681-PIP03-21 - paediatric investigation planNew
15/11/2024 Event: Public event: advancing regulatory science researchUpdated
15/11/2024 News: EMA encourages companies to submit type I variations for 2024 by end November 2024New
15/11/2024 Page: Guidance on good manufacturing practice and good distribution practice: Questions and answersUpdated
15/11/2024 Page: Human MedicinesUpdated
15/11/2024 Medicine: CelsunaxUpdated
15/11/2024 Medicine: AgamreeUpdated
15/11/2024 Medicine: JakaviUpdated
15/11/2024 Medicine: LuxturnaUpdated
15/11/2024 Medicine: AquiptaUpdated
15/11/2024 Document: Guideline on the evaluation of the benefit-risk balance of veterinary medicinal productsUpdated
15/11/2024 Document: Organisation chart: Human MedicinesUpdated
15/11/2024 Medicine: IzelvayNew
15/11/2024 Post-authorisation: Palforzia - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: GilenyaUpdated
15/11/2024 Post-authorisation: Opdivo - opinion on variation to marketing authorisationNew
15/11/2024 Post-authorisation: Yervoy - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: ObodenceNew
15/11/2024 Medicine: XbrykNew
15/11/2024 Medicine: LazcluzeNew
15/11/2024 Orphan: EU/3/19/2188 - orphan designation for treatment of neuroblastomaUpdated
15/11/2024 Page: Big dataUpdated
15/11/2024 Document: Draft European Medicines Agencies Network Data Strategy - Increasing the value of data for the benefit of public and animal healthNew
15/11/2024 Post-authorisation: Rybrevant - opinion on variation to marketing authorisationNew
15/11/2024 Post-authorisation: Kevzara - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: AugtyroNew
15/11/2024 Post-authorisation: Sarclisa - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: GohibicNew
15/11/2024 Post-authorisation: Tagrisso - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: AhzantiveNew
15/11/2024 Post-authorisation: Jakavi - opinion on variation to marketing authorisationNew
15/11/2024 Post-authorisation: Evkeeza - opinion on variation to marketing authorisationNew
15/11/2024 Post-authorisation: CellCept - opinion on variation to marketing authorisationNew
15/11/2024 Medicine: CinainuNew
15/11/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024New
15/11/2024 News: Updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioidsNew
15/11/2024 Event: Clinical Data Publication (Policy 0070) webinar - Step 2Updated
15/11/2024 News: EMA encourages companies to submit type I variations for 2024 by end November 2024New
15/11/2024 Medicine: KizfizoNew
15/11/2024 Medicine: EfmodyUpdated
15/11/2024 Page: Expert reports on big data related topicsUpdated
15/11/2024 Document: Article 57 product dataUpdated
14/11/2024 PIP: EMEA-003474-PIP01-23 - paediatric investigation planNew
14/11/2024 PIP: EMEA-003482-PIP01-23 - paediatric investigation planNew
14/11/2024 PIP: EMEA-001613-PIP03-21 - paediatric investigation planNew
14/11/2024 News: Leqembi recommended for treatment of early Alzheimer’s diseaseNew
14/11/2024 PIP: EMEA-003442-PIP01-23 - paediatric investigation planNew
14/11/2024 Medicine: LeqembiUpdated
14/11/2024 PIP: EMEA-002721-PIP04-23 - paediatric investigation planNew
14/11/2024 Medicine: VeyvondiUpdated
14/11/2024 Document: Quality Review of Documents (QRD) working group plenary meeting datesUpdated
14/11/2024 Event: Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPsUpdated
14/11/2024 Medicine: ZaviceftaUpdated
14/11/2024 Document: Minutes of the CAT meeting 11-12 September 2024New
14/11/2024 Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2024Updated
14/11/2024 Document: Highlights - Tenth Industry Standing Group (ISG) meetingNew
14/11/2024 Orphan: EU/3/24/2980 - orphan designation for treatment of dystrophic myotonia type 1New
14/11/2024 Event: HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling the safe and responsible use of AIUpdated
14/11/2024 Event: Informative webinar on PMS Product User Interface usage and key actions for Marketing Authorisation Holders (with demo)Updated
14/11/2024 Event: European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders of CAPsUpdated
14/11/2024 Medicine: YorvipathUpdated
14/11/2024 Document: CAT quarterly highlights and approved ATMPs - November 2024New
14/11/2024 Medicine: OgivriUpdated
14/11/2024 Event: Fourth listen-and-learn focus group meeting of the Quality Innovation GroupUpdated
14/11/2024 Document: CHMP PROM minutes for the meeting on 09 September 2024New
13/11/2024 PIP: EMEA-003359-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003357-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003356-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003342-PIP02-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003445-PIP01-23 - paediatric investigation planNew
13/11/2024 PSUSA: PSUSA/00010442/202401 - periodic safety update report single assessmentNew
13/11/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 22 October 2024Updated
13/11/2024 Event: Biannual Big Data Steering Group and industry stakeholders meeting - Oct 2024New
13/11/2024 Medicine: Zoledronic Acid AccordUpdated
13/11/2024 Medicine: ProliaUpdated
13/11/2024 Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 6 September 2024New
13/11/2024 Event: Training webinar on post-authorisation procedure management in IRIS for Marketing Authorisation HoldersUpdated
13/11/2024 Event: Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
13/11/2024 Event: Third European Medicines Agency (EMA) and Vaccines Europe bilateral meetingUpdated
13/11/2024 Document: Agenda - Third EMA and Vaccines Europe bilateral meetingNew
13/11/2024 Event: ACT EU workshop on ICH E6 R3 (principles and Annex 1) New
13/11/2024 Event: Third listen-and-learn focus group meeting of the Quality Innovation GroupUpdated
13/11/2024 Document: Report - 3rd Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)New
13/11/2024 Medicine: BuccolamUpdated
13/11/2024 Page: MpoxUpdated
13/11/2024 Document: ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of ageNew
12/11/2024 Medicine: EloctaUpdated
12/11/2024 Medicine: PaxlovidUpdated
12/11/2024 Medicine: VekluryUpdated
12/11/2024 Medicine: Posaconazole AHCLUpdated
12/11/2024 Medicine: AlecensaUpdated
12/11/2024 PSUSA: PSUSA/00001890/202401 - periodic safety update report single assessmentNew
12/11/2024 Medicine: BimzelxUpdated
12/11/2024 Page: CHMP opinions on consultation proceduresUpdated
12/11/2024 Page: EudraVigilance training and supportUpdated
12/11/2024 Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - FebruaryNew
12/11/2024 Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - MayNew
12/11/2024 Document: Agenda - Second European Medicines Agency (EMA) and IPFA - PPTA global bilateral meetingNew
12/11/2024 Document: Medicinal products for human use: monthly figures - October 2024New
12/11/2024 Event: New fee regulation: webinar for industry stakeholders (human)Updated
12/11/2024 Event: Paediatric Committee (PDCO): 12-15 November 2024Updated
12/11/2024 Document: Public call for expression of interest for experts to become members of the European Medicines Agency's scientific advisory groupsNew
12/11/2024 Document: Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultationUpdated
12/11/2024 Document: Ketoprofen (all ruminants, porcine and Equidae) - Summary opinion of the CVMP on the extension of maximum residue limitsUpdated
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - November 2024Updated
12/11/2024 Referral: Azithromycin-containing medicinal products for systemic use - referralUpdated
11/11/2024 Medicine: UltomirisUpdated
11/11/2024 Event: Quarterly system demo - Q4 2024New
11/11/2024 Medicine: HepcludexUpdated
11/11/2024 Document: Agenda of the CHMP meeting 11-14 November 2024New
11/11/2024 Event: Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meetingUpdated
11/11/2024 Medicine: AlprolixUpdated
11/11/2024 Medicine: Capecitabine AccordUpdated
11/11/2024 Medicine: BeovuUpdated
11/11/2024 Document: Highlights – sixth EMA/EuropaBio bilateral meetingNew
11/11/2024 Document: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2024Updated
11/11/2024 Medicine: ConveniaUpdated
11/11/2024 Medicine: BaiamaNew
11/11/2024 Medicine: CepedexUpdated
11/11/2024 Medicine: CardalisUpdated
08/11/2024 Medicine: RefixiaUpdated
08/11/2024 Medicine: AdynoviUpdated
08/11/2024 Event: Human variation electronic application form (eAF) training session and Q&A clinicUpdated
08/11/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
08/11/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 6 November 2024New
08/11/2024 Post-authorisation: Simparica Trio - opinion on variation to marketing authorisationNew
08/11/2024 Medicine: Carprofen OrionNew
08/11/2024 News: First certification of a veterinary vaccine platform technology master fileNew
08/11/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 November 2024New
08/11/2024 Medicine: VevizyeUpdated
08/11/2024 Event: New fee regulation: webinar for veterinary industry stakeholdersUpdated
08/11/2024 Medicine: TasmarUpdated
08/11/2024 DHPC: Pegasys - direct healthcare professional communication (DHPC)New
08/11/2024 Medicine: OmidriaUpdated
08/11/2024 Document: Revised list of enabling toolsNew
07/11/2024 Document: Meeting Summary of the Medicine Shortages SPOC Working Party meeting - 11 September 2024New
07/11/2024 Document: Applications for new human medicines under evaluation: November 2024New
07/11/2024 Medicine: KeppraUpdated
07/11/2024 Medicine: Canigen L4Updated
07/11/2024 Medicine: BroadlineUpdated
07/11/2024 Medicine: ZegalogueUpdated
07/11/2024 Medicine: BovelaUpdated
07/11/2024 Medicine: M-M-RVaxProUpdated
07/11/2024 PSUSA: PSUSA/00003149/202308 - periodic safety update report single assessmentNew
07/11/2024 Medicine: NucalaUpdated
07/11/2024 Medicine: Trixeo AerosphereUpdated
07/11/2024 Post-authorisation: Metalyse - opinion on variation to marketing authorisationUpdated
06/11/2024 Medicine: Versican Plus Pi/L4Updated
06/11/2024 Medicine: Versican Plus PiUpdated
06/11/2024 Medicine: Versican Plus L4Updated
06/11/2024 Medicine: Innovax-ND-IBDUpdated
06/11/2024 Medicine: Vaxxitek HVT+IBDUpdated
06/11/2024 Medicine: WyostUpdated
06/11/2024 Medicine: Porcilis PCV M HyoUpdated
06/11/2024 Medicine: Poulvac E. coliUpdated
06/11/2024 Medicine: ByettaUpdated
06/11/2024 Medicine: XeravaUpdated
06/11/2024 Medicine: Riltrava AerosphereUpdated
06/11/2024 Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authoritiesUpdated
06/11/2024 Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holdersUpdated
06/11/2024 PSUSA: PSUSA/00000300/202403 - periodic safety update report single assessmentNew
06/11/2024 Medicine: KinpeygoUpdated
06/11/2024 Event: SPOR Status UpdateUpdated
06/11/2024 Medicine: TofidenceUpdated
06/11/2024 Medicine: XalkoriUpdated
06/11/2024 Medicine: Pemetrexed SandozUpdated
06/11/2024 Page: Emergency Task Force (ETF)Updated
06/11/2024 Event: Committee for Advanced Therapies (CAT): 6-8 November 2024Updated
06/11/2024 Document: Agenda of the CAT meeting 6-8 November 2024New
05/11/2024 Medicine: Porcilis ColiClosUpdated
05/11/2024 Medicine: ArthriCoxUpdated
05/11/2024 Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilanceNew
05/11/2024 Document: Agenda of the COMP meeting 5-7 November 2024New
05/11/2024 Medicine: Cirbloc M HyoUpdated
05/11/2024 Page: Executive Steering Group on Shortages and Safety of Medicinal ProductsUpdated
05/11/2024 Event: EMA risk management information day 2024New
05/11/2024 Document: Nominations to the Network Portfolio Advisory GroupUpdated
05/11/2024 Medicine: YuflymaUpdated
05/11/2024 Page: Stakeholder participation in information managementUpdated
05/11/2024 Medicine: Nobivac DP PlusUpdated
05/11/2024 Page: SME Regulation and reportsUpdated
05/11/2024 Medicine: Hiprabovis IBR Marker LiveUpdated
05/11/2024 Medicine: AdvagrafUpdated
05/11/2024 PSUSA: PSUSA/00000007/202312 - periodic safety update report single assessmentNew
05/11/2024 Page: Vaccines Working PartyUpdated
05/11/2024 Document: Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027New
05/11/2024 Medicine: ModigrafUpdated
05/11/2024 Medicine: VidazaUpdated
05/11/2024 Medicine: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)Updated
05/11/2024 Medicine: CejemlyUpdated
05/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - October 2024Updated
05/11/2024 Document: EVVet3 EVWeb Production - Release notesUpdated
05/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2024Updated
04/11/2024 PSUSA: PSUSA/00002170/202403 - periodic safety update report single assessmentNew
04/11/2024 PSUSA: PSUSA/00010802/202403 - periodic safety update report single assessmentNew
04/11/2024 Medicine: QdengaUpdated
04/11/2024 Document: Minutes of the CHMP meeting 27-30 May 2024New
04/11/2024 Document: PDCO minutes of the 3-6 September 2024 meetingNew
04/11/2024 Medicine: AflunovUpdated
04/11/2024 Document: Network ICT Advisory Committee (NICTAC) - List of nominated membersUpdated
04/11/2024 Medicine: TrydonisUpdated
04/11/2024 EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) TakedaUpdated
04/11/2024 Page: Questions and answers on Article 82 referral proceduresNew
04/11/2024 Medicine: PradaxaUpdated
04/11/2024 Medicine: LibtayoUpdated
04/11/2024 Page: Questions and answers on Article 82 referral procedures based on Article 129(3)New
04/11/2024 PSUSA: PSUSA/00009162/202403 - periodic safety update report single assessmentNew
04/11/2024 PSUSA: PSUSA/00001997/202403 - periodic safety update report single assessmentNew