20/11/2024 | Medicine: Tenkasi (previously Orbactiv) | Updated |
20/11/2024 | Medicine: Mycamine | Updated |
20/11/2024 | PIP: EMEA-001741-PIP09-23 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-001741-PIP08-22 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-003379-PIP01-22 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-002705-PIP05-23 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-003307-PIP01-22 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-001521-PIP03-22 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-003363-PIP01-22 - paediatric investigation plan | New |
20/11/2024 | PIP: EMEA-003033-PIP02-22 - paediatric investigation plan | New |
20/11/2024 | Orphan: EU/3/24/2986 - orphan designation for treatment of amyotrophic lateral sclerosis | New |
20/11/2024 | Orphan: EU/3/24/2979 - orphan designation for treatment of hereditary angioedema | New |
20/11/2024 | Orphan: EU/3/24/2982 - orphan designation for treatment of retinoblastoma | New |
20/11/2024 | Document: QRD Appendix I - Adverse event (PhV) MSs reporting details | Updated |
20/11/2024 | Orphan: EU/3/24/2981 - orphan designation for treatment of frontotemporal dementia | New |
20/11/2024 | Document: Network Portfolio Roadmap | Updated |
20/11/2024 | Orphan: EU/3/24/2978 - orphan designation for treatment of chondrosarcoma | New |
20/11/2024 | Document: Minutes of the COMP meeting 08-10 October 2024 | New |
20/11/2024 | Document: Draft concept paper on the European Platform for Regulatory Science Research | Updated |
20/11/2024 | Document: Draft Regulatory Science Research Needs - 2024 update | Updated |
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 nephropathy | New |
20/11/2024 | Medicine: Kalydeco | Updated |
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 fibrosis | New |
20/11/2024 | Orphan: EU/3/24/2983 - orphan designation for treatment of cutaneous T-cell lymphoma | New |
20/11/2024 | Document: Social Media Data for Real World Evidence in Regulatory Decision Making | Updated |
20/11/2024 | Page: Procurement | Updated |
20/11/2024 | Document: CTIS newsflash - 19 November 2024 | New |
20/11/2024 | Page: Medical devices | Updated |
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 Panels | New |
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 2024-10 | New |
20/11/2024 | Medicine: Jinarc | Updated |
20/11/2024 | Medicine: Nezglyal | Updated |
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: Kisqali | Updated |
20/11/2024 | Medicine: Ibrance | Updated |
20/11/2024 | Post-authorisation: Inaqovi - withdrawal of application for variation to marketing authorisation | Updated |
20/11/2024 | Document: Agenda of the HMPC meeting 18-20 November 2024 | New |
20/11/2024 | Post-authorisation: Keytruda - opinion on variation to marketing authorisation | Updated |
20/11/2024 | Medicine: Elfabrio | Updated |
20/11/2024 | Medicine: Keytruda | Updated |
20/11/2024 | Event: Fifth EMA/HMA Big Data Stakeholder Forum | Updated |
20/11/2024 | Medicine: Fluenz | Updated |
19/11/2024 | Page: European Shortages Monitoring Platform | Updated |
19/11/2024 | Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders | New |
19/11/2024 | PIP: EMEA-003446-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003362-PIP01-22 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003452-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003368-PIP01-22 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-002830-PIP01-20 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003449-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003450-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003347-PIP01-22 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003461-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | PIP: EMEA-003456-PIP01-23 - paediatric investigation plan | New |
19/11/2024 | Medicine: Ordspono | Updated |
19/11/2024 | Page: Plasma master file certificates | Updated |
19/11/2024 | Orphan: EU/3/14/1360 - orphan designation for treatment of haemophilia A | Updated |
19/11/2024 | Orphan: EU/3/24/2988 - orphan designation for treatment of glioma | New |
19/11/2024 | Orphan: EU/3/24/2991 - orphan designation for treatment of ATTR amyloidosis | New |
19/11/2024 | Orphan: EU/3/24/2990 - orphan designation for treatment of spinal cord injury | New |
19/11/2024 | Orphan: EU/3/21/2440 - orphan designation for treatment of X-linked severe combined immunodeficiency | Updated |
19/11/2024 | Orphan: EU/3/21/2546 - orphan designation for treatment of acute lymphoblastic leukaemia | Updated |
19/11/2024 | Orphan: EU/3/20/2362 - orphan designation for treatment of X-linked severe combined immunodeficiency | Updated |
19/11/2024 | Orphan: EU/3/23/2866 - orphan designation for treatment of haemophilia B | Updated |
19/11/2024 | Orphan: EU/3/20/2293 - orphan designation for treatment of Becker muscular dystrophy | Updated |
19/11/2024 | Orphan: EU/3/22/2677 - orphan designation for treatment of haemophilia A | Updated |
19/11/2024 | Orphan: EU/3/24/2977 - orphan designation for treatment of pancreatic cancer | New |
19/11/2024 | Orphan: EU/3/24/2984 - orphan designation for treatment of autosomal dominant polycystic liver disease | New |
19/11/2024 | Page: Nitrosamine impurities | Updated |
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 holders | New |
19/11/2024 | Page: Nitrosamine impurities in specific medicines | New |
19/11/2024 | Orphan: EU/3/17/1868 - orphan designation for treatment of fragile X syndrome | Updated |
19/11/2024 | Medicine: Kymriah | Updated |
19/11/2024 | Orphan: EU/3/15/1602 - orphan designation for treatment of anal cancer | Updated |
19/11/2024 | Orphan: EU/3/19/2234 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
19/11/2024 | Medicine: Jayempi | Updated |
18/11/2024 | Event: UPD refresher webinar for marketing authorisation holders on volume of sales submission | New |
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 requests | Updated |
18/11/2024 | Medicine: Pylclari | Updated |
18/11/2024 | Page: Clinical Trials Information System (CTIS): training and support | Updated |
18/11/2024 | Medicine: Ganfort | Updated |
18/11/2024 | Medicine: Lumigan | Updated |
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 1 | New |
18/11/2024 | Page: Antimicrobial resistance | Updated |
18/11/2024 | Document: Antimicrobial resistance: A call to action against the silent pandemic | New |
18/11/2024 | Document: Agenda - HMA-EMA Big Data Stakeholder Forum 2024 | Updated |
18/11/2024 | Page: Extended EudraVigilance medicinal product dictionary (XEVMPD) training | Updated |
18/11/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February 2025 | New |
18/11/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - June 2025 | New |
18/11/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - May 2025 | New |
18/11/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - March 2025 | New |
18/11/2024 | Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - April 2025 | New |
18/11/2024 | Medicine: MenQuadfi | Updated |
15/11/2024 | Event: Eleventh Industry Standing Group (ISG) meeting | New |
15/11/2024 | PIP: EMEA-003025-PIP03-23 - paediatric investigation plan | New |
15/11/2024 | PIP: EMEA-003455-PIP01-23 - paediatric investigation plan | New |
15/11/2024 | PIP: EMEA-003063-PIP03-22 - paediatric investigation plan | New |
15/11/2024 | PIP: EMEA-003321-PIP01-22 - paediatric investigation plan | New |
15/11/2024 | PIP: EMEA-002681-PIP03-21 - paediatric investigation plan | New |
15/11/2024 | Event: Public event: advancing regulatory science research | Updated |
15/11/2024 | News: EMA encourages companies to submit type I variations for 2024 by end November 2024 | New |
15/11/2024 | Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers | Updated |
15/11/2024 | Page: Human Medicines | Updated |
15/11/2024 | Medicine: Celsunax | Updated |
15/11/2024 | Medicine: Agamree | Updated |
15/11/2024 | Medicine: Jakavi | Updated |
15/11/2024 | Medicine: Luxturna | Updated |
15/11/2024 | Medicine: Aquipta | Updated |
15/11/2024 | Document: Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products | Updated |
15/11/2024 | Document: Organisation chart: Human Medicines | Updated |
15/11/2024 | Medicine: Izelvay | New |
15/11/2024 | Post-authorisation: Palforzia - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Gilenya | Updated |
15/11/2024 | Post-authorisation: Opdivo - opinion on variation to marketing authorisation | New |
15/11/2024 | Post-authorisation: Yervoy - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Obodence | New |
15/11/2024 | Medicine: Xbryk | New |
15/11/2024 | Medicine: Lazcluze | New |
15/11/2024 | Orphan: EU/3/19/2188 - orphan designation for treatment of neuroblastoma | Updated |
15/11/2024 | Page: Big data | Updated |
15/11/2024 | Document: Draft European Medicines Agencies Network Data Strategy - Increasing the value of data for the benefit of public and animal health | New |
15/11/2024 | Post-authorisation: Rybrevant - opinion on variation to marketing authorisation | New |
15/11/2024 | Post-authorisation: Kevzara - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Augtyro | New |
15/11/2024 | Post-authorisation: Sarclisa - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Gohibic | New |
15/11/2024 | Post-authorisation: Tagrisso - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Ahzantive | New |
15/11/2024 | Post-authorisation: Jakavi - opinion on variation to marketing authorisation | New |
15/11/2024 | Post-authorisation: Evkeeza - opinion on variation to marketing authorisation | New |
15/11/2024 | Post-authorisation: CellCept - opinion on variation to marketing authorisation | New |
15/11/2024 | Medicine: Cinainu | New |
15/11/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024 | New |
15/11/2024 | News: Updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids | New |
15/11/2024 | Event: Clinical Data Publication (Policy 0070) webinar - Step 2 | Updated |
15/11/2024 | News: EMA encourages companies to submit type I variations for 2024 by end November 2024 | New |
15/11/2024 | Medicine: Kizfizo | New |
15/11/2024 | Medicine: Efmody | Updated |
15/11/2024 | Page: Expert reports on big data related topics | Updated |
15/11/2024 | Document: Article 57 product data | Updated |
14/11/2024 | PIP: EMEA-003474-PIP01-23 - paediatric investigation plan | New |
14/11/2024 | PIP: EMEA-003482-PIP01-23 - paediatric investigation plan | New |
14/11/2024 | PIP: EMEA-001613-PIP03-21 - paediatric investigation plan | New |
14/11/2024 | News: Leqembi recommended for treatment of early Alzheimer’s disease | New |
14/11/2024 | PIP: EMEA-003442-PIP01-23 - paediatric investigation plan | New |
14/11/2024 | Medicine: Leqembi | Updated |
14/11/2024 | PIP: EMEA-002721-PIP04-23 - paediatric investigation plan | New |
14/11/2024 | Medicine: Veyvondi | Updated |
14/11/2024 | Document: Quality Review of Documents (QRD) working group plenary meeting dates | Updated |
14/11/2024 | Event: Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs | Updated |
14/11/2024 | Medicine: Zavicefta | Updated |
14/11/2024 | Document: Minutes of the CAT meeting 11-12 September 2024 | New |
14/11/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2024 | Updated |
14/11/2024 | Document: Highlights - Tenth Industry Standing Group (ISG) meeting | New |
14/11/2024 | Orphan: EU/3/24/2980 - orphan designation for treatment of dystrophic myotonia type 1 | New |
14/11/2024 | Event: HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling the safe and responsible use of AI | Updated |
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 CAPs | Updated |
14/11/2024 | Medicine: Yorvipath | Updated |
14/11/2024 | Document: CAT quarterly highlights and approved ATMPs - November 2024 | New |
14/11/2024 | Medicine: Ogivri | Updated |
14/11/2024 | Event: Fourth listen-and-learn focus group meeting of the Quality Innovation Group | Updated |
14/11/2024 | Document: CHMP PROM minutes for the meeting on 09 September 2024 | New |
13/11/2024 | PIP: EMEA-003359-PIP01-22 - paediatric investigation plan | New |
13/11/2024 | PIP: EMEA-003357-PIP01-22 - paediatric investigation plan | New |
13/11/2024 | PIP: EMEA-003356-PIP01-22 - paediatric investigation plan | New |
13/11/2024 | PIP: EMEA-003342-PIP02-22 - paediatric investigation plan | New |
13/11/2024 | PIP: EMEA-003445-PIP01-23 - paediatric investigation plan | New |
13/11/2024 | PSUSA: PSUSA/00010442/202401 - periodic safety update report single assessment | New |
13/11/2024 | Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 22 October 2024 | Updated |
13/11/2024 | Event: Biannual Big Data Steering Group and industry stakeholders meeting - Oct 2024 | New |
13/11/2024 | Medicine: Zoledronic Acid Accord | Updated |
13/11/2024 | Medicine: Prolia | Updated |
13/11/2024 | Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 6 September 2024 | New |
13/11/2024 | Event: Training webinar on post-authorisation procedure management in IRIS for Marketing Authorisation Holders | Updated |
13/11/2024 | Event: Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
13/11/2024 | Event: Third European Medicines Agency (EMA) and Vaccines Europe bilateral meeting | Updated |
13/11/2024 | Document: Agenda - Third EMA and Vaccines Europe bilateral meeting | New |
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 Group | Updated |
13/11/2024 | Document: Report - 3rd Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG) | New |
13/11/2024 | Medicine: Buccolam | Updated |
13/11/2024 | Page: Mpox | Updated |
13/11/2024 | Document: ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of age | New |
12/11/2024 | Medicine: Elocta | Updated |
12/11/2024 | Medicine: Paxlovid | Updated |
12/11/2024 | Medicine: Veklury | Updated |
12/11/2024 | Medicine: Posaconazole AHCL | Updated |
12/11/2024 | Medicine: Alecensa | Updated |
12/11/2024 | PSUSA: PSUSA/00001890/202401 - periodic safety update report single assessment | New |
12/11/2024 | Medicine: Bimzelx | Updated |
12/11/2024 | Page: CHMP opinions on consultation procedures | Updated |
12/11/2024 | Page: EudraVigilance training and support | Updated |
12/11/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - February | New |
12/11/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - May | New |
12/11/2024 | Document: Agenda - Second European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting | New |
12/11/2024 | Document: Medicinal products for human use: monthly figures - October 2024 | New |
12/11/2024 | Event: New fee regulation: webinar for industry stakeholders (human) | Updated |
12/11/2024 | Event: Paediatric Committee (PDCO): 12-15 November 2024 | Updated |
12/11/2024 | Document: Public call for expression of interest for experts to become members of the European Medicines Agency's scientific advisory groups | New |
12/11/2024 | Document: Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation | Updated |
12/11/2024 | Document: Ketoprofen (all ruminants, porcine and Equidae) - Summary opinion of the CVMP on the extension of maximum residue limits | Updated |
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 system | New |
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 system | New |
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 system | New |
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 system | New |
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 system | New |
12/11/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - November 2024 | Updated |
12/11/2024 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
11/11/2024 | Medicine: Ultomiris | Updated |
11/11/2024 | Event: Quarterly system demo - Q4 2024 | New |
11/11/2024 | Medicine: Hepcludex | Updated |
11/11/2024 | Document: Agenda of the CHMP meeting 11-14 November 2024 | New |
11/11/2024 | Event: Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting | Updated |
11/11/2024 | Medicine: Alprolix | Updated |
11/11/2024 | Medicine: Capecitabine Accord | Updated |
11/11/2024 | Medicine: Beovu | Updated |
11/11/2024 | Document: Highlights – sixth EMA/EuropaBio bilateral meeting | New |
11/11/2024 | Document: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2024 | Updated |
11/11/2024 | Medicine: Convenia | Updated |
11/11/2024 | Medicine: Baiama | New |
11/11/2024 | Medicine: Cepedex | Updated |
11/11/2024 | Medicine: Cardalis | Updated |
08/11/2024 | Medicine: Refixia | Updated |
08/11/2024 | Medicine: Adynovi | Updated |
08/11/2024 | Event: Human variation electronic application form (eAF) training session and Q&A clinic | Updated |
08/11/2024 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
08/11/2024 | Document: Agenda - Medicine Shortages (SPOC) Working Party 6 November 2024 | New |
08/11/2024 | Post-authorisation: Simparica Trio - opinion on variation to marketing authorisation | New |
08/11/2024 | Medicine: Carprofen Orion | New |
08/11/2024 | News: First certification of a veterinary vaccine platform technology master file | New |
08/11/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 November 2024 | New |
08/11/2024 | Medicine: Vevizye | Updated |
08/11/2024 | Event: New fee regulation: webinar for veterinary industry stakeholders | Updated |
08/11/2024 | Medicine: Tasmar | Updated |
08/11/2024 | DHPC: Pegasys - direct healthcare professional communication (DHPC) | New |
08/11/2024 | Medicine: Omidria | Updated |
08/11/2024 | Document: Revised list of enabling tools | New |
07/11/2024 | Document: Meeting Summary of the Medicine Shortages SPOC Working Party meeting - 11 September 2024 | New |
07/11/2024 | Document: Applications for new human medicines under evaluation: November 2024 | New |
07/11/2024 | Medicine: Keppra | Updated |
07/11/2024 | Medicine: Canigen L4 | Updated |
07/11/2024 | Medicine: Broadline | Updated |
07/11/2024 | Medicine: Zegalogue | Updated |
07/11/2024 | Medicine: Bovela | Updated |
07/11/2024 | Medicine: M-M-RVaxPro | Updated |
07/11/2024 | PSUSA: PSUSA/00003149/202308 - periodic safety update report single assessment | New |
07/11/2024 | Medicine: Nucala | Updated |
07/11/2024 | Medicine: Trixeo Aerosphere | Updated |
07/11/2024 | Post-authorisation: Metalyse - opinion on variation to marketing authorisation | Updated |
06/11/2024 | Medicine: Versican Plus Pi/L4 | Updated |
06/11/2024 | Medicine: Versican Plus Pi | Updated |
06/11/2024 | Medicine: Versican Plus L4 | Updated |
06/11/2024 | Medicine: Innovax-ND-IBD | Updated |
06/11/2024 | Medicine: Vaxxitek HVT+IBD | Updated |
06/11/2024 | Medicine: Wyost | Updated |
06/11/2024 | Medicine: Porcilis PCV M Hyo | Updated |
06/11/2024 | Medicine: Poulvac E. coli | Updated |
06/11/2024 | Medicine: Byetta | Updated |
06/11/2024 | Medicine: Xerava | Updated |
06/11/2024 | Medicine: Riltrava Aerosphere | Updated |
06/11/2024 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities | Updated |
06/11/2024 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders | Updated |
06/11/2024 | PSUSA: PSUSA/00000300/202403 - periodic safety update report single assessment | New |
06/11/2024 | Medicine: Kinpeygo | Updated |
06/11/2024 | Event: SPOR Status Update | Updated |
06/11/2024 | Medicine: Tofidence | Updated |
06/11/2024 | Medicine: Xalkori | Updated |
06/11/2024 | Medicine: Pemetrexed Sandoz | Updated |
06/11/2024 | Page: Emergency Task Force (ETF) | Updated |
06/11/2024 | Event: Committee for Advanced Therapies (CAT): 6-8 November 2024 | Updated |
06/11/2024 | Document: Agenda of the CAT meeting 6-8 November 2024 | New |
05/11/2024 | Medicine: Porcilis ColiClos | Updated |
05/11/2024 | Medicine: ArthriCox | Updated |
05/11/2024 | Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance | New |
05/11/2024 | Document: Agenda of the COMP meeting 5-7 November 2024 | New |
05/11/2024 | Medicine: Cirbloc M Hyo | Updated |
05/11/2024 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products | Updated |
05/11/2024 | Event: EMA risk management information day 2024 | New |
05/11/2024 | Document: Nominations to the Network Portfolio Advisory Group | Updated |
05/11/2024 | Medicine: Yuflyma | Updated |
05/11/2024 | Page: Stakeholder participation in information management | Updated |
05/11/2024 | Medicine: Nobivac DP Plus | Updated |
05/11/2024 | Page: SME Regulation and reports | Updated |
05/11/2024 | Medicine: Hiprabovis IBR Marker Live | Updated |
05/11/2024 | Medicine: Advagraf | Updated |
05/11/2024 | PSUSA: PSUSA/00000007/202312 - periodic safety update report single assessment | New |
05/11/2024 | Page: Vaccines Working Party | Updated |
05/11/2024 | Document: Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027 | New |
05/11/2024 | Medicine: Modigraf | Updated |
05/11/2024 | Medicine: Vidaza | Updated |
05/11/2024 | Medicine: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) | Updated |
05/11/2024 | Medicine: Cejemly | Updated |
05/11/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - October 2024 | Updated |
05/11/2024 | Document: EVVet3 EVWeb Production - Release notes | Updated |
05/11/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2024 | Updated |
04/11/2024 | PSUSA: PSUSA/00002170/202403 - periodic safety update report single assessment | New |
04/11/2024 | PSUSA: PSUSA/00010802/202403 - periodic safety update report single assessment | New |
04/11/2024 | Medicine: Qdenga | Updated |
04/11/2024 | Document: Minutes of the CHMP meeting 27-30 May 2024 | New |
04/11/2024 | Document: PDCO minutes of the 3-6 September 2024 meeting | New |
04/11/2024 | Medicine: Aflunov | Updated |
04/11/2024 | Document: Network ICT Advisory Committee (NICTAC) - List of nominated members | Updated |
04/11/2024 | Medicine: Trydonis | Updated |
04/11/2024 | EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda | Updated |
04/11/2024 | Page: Questions and answers on Article 82 referral procedures | New |
04/11/2024 | Medicine: Pradaxa | Updated |
04/11/2024 | Medicine: Libtayo | Updated |
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 assessment | New |
04/11/2024 | PSUSA: PSUSA/00001997/202403 - periodic safety update report single assessment | New |