12/06/2024 | Page: Avian influenza (bird flu) | Updated |
12/06/2024 | Document: Agenda - Biannual Big Data Steering Group and industry stakeholders meeting 2024 | New |
12/06/2024 | Document: Summary report - - Biannual Big Data Steering Group and industry stakeholders meeting 2024 | New |
12/06/2024 | Page: Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
12/06/2024 | Document: Overview of (invented) names reviewed in April 2024 by the Name Review Group (NRG) adopted at the CHMP meeting of 27-30 May 2024 | New |
12/06/2024 | Document: Network Portfolio Roadmap | Updated |
12/06/2024 | Medicine: Xenpozyme | Updated |
12/06/2024 | Medicine: Ozempic | Updated |
12/06/2024 | Document: Minimum inhibitory concentration (MIC) breakpoints | Updated |
12/06/2024 | Medicine: Wegovy | Updated |
12/06/2024 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies | Updated |
12/06/2024 | Event: Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices | Updated |
12/06/2024 | Medicine: Aubagio | Updated |
12/06/2024 | Event: Quarterly System Demo – Q2 2024 | Updated |
12/06/2024 | Medicine: Cervarix | Updated |
12/06/2024 | Medicine: Pedmarqsi | Updated |
12/06/2024 | Medicine: Opfolda | Updated |
12/06/2024 | Medicine: Comirnaty | Updated |
12/06/2024 | Document: HMPC: overview of assessment work - priority list | Updated |
12/06/2024 | Document: Minutes of the CAT meeting 17-19 January 2024 | Updated |
12/06/2024 | Document: Minutes of the PRAC meeting 8-11 April 2024 | New |
12/06/2024 | Document: Minutes of the CHMP meeting 18-21 March 2024 | New |
12/06/2024 | Document: CHMP PROM minutes for the meeting on 11 March 2024 | New |
12/06/2024 | Event: Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting | Updated |
12/06/2024 | Document: Meeting Summary - Medicine Shortages Single Point of Contact (SPOC) Working Party - 15-16 April 2024 | New |
12/06/2024 | PSUSA: PSUSA/00002607/202308 - periodic safety update report single assessment | New |
12/06/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 18-20 March 2024 | Updated |
12/06/2024 | Document: Minutes of the HMPC meeting 18-20 March 2024 | New |
12/06/2024 | Medicine: Imfinzi | Updated |
12/06/2024 | Medicine: Soliris | Updated |
12/06/2024 | Event: Fourth European Medicines Agency and Nuclear Medicines Europe bilateral meeting | New |
06/06/2024 | Event: Product Management Service (PMS) Product UI training (access & navigation) | Updated |
11/06/2024 | Medicine: Glyxambi | Updated |
11/06/2024 | Medicine: Credelio Plus | Updated |
11/06/2024 | Medicine: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) | Updated |
11/06/2024 | Medicine: Pyzchiva | Updated |
11/06/2024 | Medicine: Opdivo | Updated |
11/06/2024 | PSUSA: PSUSA/00001897/202308 - periodic safety update report single assessment | New |
11/06/2024 | PSUSA: PSUSA/00002125/202308 - periodic safety update report single assessment | New |
11/06/2024 | Event: Third listen-and-learn focus group meeting of the Quality Innovation Group | Updated |
11/06/2024 | Event: European Shortages Monitoring Platform Essentials and Industry Reporting Requirements | Updated |
11/06/2024 | Event: Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS | Updated |
11/06/2024 | Medicine: MiPet Easecto | Updated |
11/06/2024 | Medicine: Simparica | Updated |
11/06/2024 | Medicine: Hexyon | Updated |
11/06/2024 | Medicine: Hexacima | Updated |
11/06/2024 | Medicine: Veltassa | Updated |
11/06/2024 | Medicine: Litfulo | Updated |
11/06/2024 | Medicine: Improvac | Updated |
11/06/2024 | Medicine: Vumerity | Updated |
11/06/2024 | Referral: Micrazym and associated names - referral | Updated |
11/06/2024 | Medicine: Respivac TRT | Updated |
11/06/2024 | Medicine: Libmyris | Updated |
11/06/2024 | Medicine: Nuvaxovid | Updated |
10/06/2024 | Medicine: Respreeza | Updated |
10/06/2024 | Medicine: Zykadia | Updated |
10/06/2024 | Document: Agenda of the PRAC meeting 10-13 June 2024 | New |
10/06/2024 | Document: Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa | Updated |
10/06/2024 | Document: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level | Updated |
10/06/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 22 April 2024 | New |
10/06/2024 | Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
10/06/2024 | Medicine: Intuniv | Updated |
10/06/2024 | News: Two new advice pilots to improve clinical trials in Europe | New |
10/06/2024 | Document: Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars | Updated |
10/06/2024 | Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC | New |
10/06/2024 | Document: PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meeting | New |
10/06/2024 | Document: List of signals discussed at PRAC since September 2012 | Updated |
07/06/2024 | PIP: EMEA-003184-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | Page: Website outages and upgrades | Updated |
07/06/2024 | Document: Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
07/06/2024 | PIP: EMEA-003080-PIP03-22 - paediatric investigation plan | New |
07/06/2024 | Document: Change management activities delivery plan | New |
07/06/2024 | Event: Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
07/06/2024 | Document: Workplan 2023-2025: HMA-EMA joint Big Data Steering Group | Updated |
07/06/2024 | PIP: EMEA-002612-PIP02-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003079-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | Orphan: EU/3/13/1200 - orphan designation for treatment of papillary thyroid cancer | Updated |
07/06/2024 | Orphan: EU/3/13/1199 - orphan designation for treatment of follicular thyroid cancer | Updated |
07/06/2024 | Medicine: Nexavar | Updated |
07/06/2024 | Medicine: Sylvant | Updated |
07/06/2024 | Orphan: EU/3/07/508 - orphan designation for treatment of Castleman's disease | Updated |
07/06/2024 | Medicine: Lamivudine Teva | Updated |
07/06/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
07/06/2024 | PIP: EMEA-000032-PIP02-22 - paediatric investigation plan | New |
07/06/2024 | Medicine: Irbesartan/Hydrochlorothiazide Teva | Updated |
07/06/2024 | Event: New Fee Regulation: webinar for veterinary Marketing Authorisation Holders | Updated |
07/06/2024 | PIP: EMEA-003370-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003364-PIP02-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003339-PIP02-23 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003302-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003279-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003251-PIP01-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-003208-PIP02-22 - paediatric investigation plan | New |
07/06/2024 | PIP: EMEA-001231-PIP02-13-M10 - paediatric investigation plan | Updated |
07/06/2024 | PIP: EMEA-001523-PIP04-19-M02 - paediatric investigation plan | Updated |
07/06/2024 | PIP: EMEA-001490-PIP01-13-M04 - paediatric investigation plan | Updated |
07/06/2024 | PIP: EMEA-001238-PIP03-21-M01 - paediatric investigation plan | Updated |
07/06/2024 | Medicine: Parsabiv | Updated |
06/06/2024 | PIP: EMEA-001214-PIP09-21-M01 - paediatric investigation plan | Updated |
06/06/2024 | PIP: EMEA-001194-PIP01-11-M06 - paediatric investigation plan | Updated |
06/06/2024 | PIP: EMEA-001075-PIP04-15-M06 - paediatric investigation plan | Updated |
06/06/2024 | PIP: EMEA-000973-PIP01-10-M04 - paediatric investigation plan | Updated |
06/06/2024 | PIP: EMEA-000353-PIP02-16-M03 - paediatric investigation plan | Updated |
06/06/2024 | PIP: EMEA-000115-PIP01-07-M13 - paediatric investigation plan | Updated |
06/06/2024 | Medicine: Skyclarys | Updated |
06/06/2024 | Medicine: Rizmoic | Updated |
06/06/2024 | Medicine: Hizentra | Updated |
06/06/2024 | Medicine: Sitagliptin / Metformin hydrochloride Sun | Updated |
06/06/2024 | Medicine: Byfavo | Updated |
06/06/2024 | Medicine: Tysabri | Updated |
06/06/2024 | Medicine: Mimpara | Updated |
06/06/2024 | Medicine: Jubbonti | Updated |
06/06/2024 | Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animals | Updated |
06/06/2024 | Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) | Updated |
06/06/2024 | Medicine: Qdenga | Updated |
06/06/2024 | Page: Pharmacovigilance: Overview | Updated |
06/06/2024 | Document: Research projects conducted under the remit of the PRAC impact strategy | New |
06/06/2024 | PSUSA: PSUSA/00003043/202308 - periodic safety update report single assessment | New |
06/06/2024 | Medicine: Enbrel | Updated |
06/06/2024 | Medicine: Trodelvy | Updated |
06/06/2024 | Medicine: Myocet liposomal (previously Myocet) | Updated |
06/06/2024 | Medicine: Giapreza | Updated |
06/06/2024 | Page: Plasma master file certificates | Updated |
05/06/2024 | Page: Vaccine Monitoring Platform | Updated |
05/06/2024 | PSUSA: PSUSA/00003121/202308 - periodic safety update report single assessment | New |
05/06/2024 | DHPC: Kexxtone - direct healthcare professional communication (DHPC) | New |
05/06/2024 | Medicine: Reyataz | Updated |
05/06/2024 | Medicine: Erbitux | Updated |
05/06/2024 | Medicine: Beyfortus | Updated |
05/06/2024 | Medicine: PecFent | Updated |
05/06/2024 | Document: Salbutamol inhalation products suppy shortage | New |
05/06/2024 | Referral: Synapse - referral | Updated |
05/06/2024 | Referral: Ibuprofen NVT - referral | Updated |
05/06/2024 | Medicine: Alprolix | Updated |
05/06/2024 | Page: EudraVigilance training and support | Updated |
05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
05/06/2024 | Medicine: Camcevi | Updated |
05/06/2024 | Medicine: Abilify Maintena | Updated |
05/06/2024 | Page: PRIME: priority medicines | Updated |
05/06/2024 | Document: List of medicines currently in PRIME scheme | Updated |
05/06/2024 | Document: Application form for European Medicines Agency certificates of medicinal products | Updated |
04/06/2024 | Medicine: Xromi | Updated |
04/06/2024 | Document: Procedural advice on paediatric applications | Updated |
04/06/2024 | Medicine: Oxbryta | Updated |
04/06/2024 | Medicine: Onpattro | Updated |
04/06/2024 | Medicine: Suliqua | Updated |
04/06/2024 | Medicine: Xultophy | Updated |
04/06/2024 | PSUSA: PSUSA/00002114/202308 - periodic safety update report single assessment | New |
04/06/2024 | Document: Application form to request Simultaneous National Scientific Advice (SNSA) or a pre-CTA Advice | New |
04/06/2024 | Referral: Kexxtone 32.4 g continuous-release intraruminal device for cattle - referral | New |
03/06/2024 | Medicine: Credelio | Updated |
03/06/2024 | News: EU recommendations for 2024/2025 seasonal flu vaccine composition | Updated |
03/06/2024 | Document: 2023 annual report of the European Medicines Agency | Updated |
03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process | New |
03/06/2024 | Document: SNSA procedural flowchart | New |
03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content | New |
03/06/2024 | Document: SNSA – Involvement of NCAs | New |
03/06/2024 | Document: SNSA meeting minutes template for applicants | New |
03/06/2024 | Document: SNSA final advice report template | New |
03/06/2024 | Referral: Ocaliva - referral | Updated |
03/06/2024 | Page: Class waivers | Updated |
03/06/2024 | Page: Annual report on deferrals | Updated |
03/06/2024 | Page: Paediatric investigation plans | Updated |
03/06/2024 | Page: Paediatric investigation plans: questions and answers | Updated |
03/06/2024 | Page: Paediatric investigation plans: Templates and forms | Updated |
03/06/2024 | Page: Paediatric medicines: Overview | Updated |
03/06/2024 | Page: Paediatric medicines: Research and development | Updated |
03/06/2024 | Page: Paediatric medicines: applications and procedures | New |
03/06/2024 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
03/06/2024 | Medicine: Xarelto | Updated |
03/06/2024 | Page: Information Management | Updated |
03/06/2024 | Document: Template - Request for compliance check on an agreed paediatric investigation plan (PIP) | Updated |
03/06/2024 | Medicine: Dacogen | Updated |
03/06/2024 | PIP: EMEA-003371-PIP01-22 - paediatric investigation plan | New |
03/06/2024 | Document: Template for scientific document | Updated |
03/06/2024 | Document: Paediatric investigation plan (PIP) - Key elements guidance | Updated |
03/06/2024 | Medicine: SomaKit TOC | Updated |
03/06/2024 | Medicine: Sunitinib Accord | Updated |
03/06/2024 | Medicine: Suboxone | Updated |
03/06/2024 | Medicine: Circovac | Updated |
03/06/2024 | Medicine: Filspari | Updated |
03/06/2024 | Medicine: Awiqli | Updated |
03/06/2024 | Medicine: Xtandi | Updated |
03/06/2024 | Page: Recommendations on medication errors | Updated |
03/06/2024 | Medicine: Bravecto | Updated |
03/06/2024 | Medicine: Imjudo | Updated |
03/06/2024 | Medicine: Bimervax | Updated |
03/06/2024 | Medicine: Cufence | Updated |
03/06/2024 | Medicine: Zilbrysq | Updated |
03/06/2024 | Medicine: Innovax-ND-H5 | Updated |
03/06/2024 | Medicine: Rozlytrek | Updated |
03/06/2024 | Medicine: Omlyclo | Updated |
03/06/2024 | Document: CTIS newsflash - 31 May 2024 | New |
03/06/2024 | Document: Shortage of human normal immunoglobulins | New |
03/06/2024 | Page: Removing an orphan designation | Updated |