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06/07/2018 Other: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)
06/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): thrombin alfa, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/62/2008
06/07/2018 Other: Recothrom - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/07/2018 Other: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP
06/07/2018 Substance and product data management services
06/07/2018 Presentation: Presentation - Substance and product management services (P&SMS) update
06/07/2018 Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
06/07/2018 Scientific guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2018
06/07/2018 Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
06/07/2018 Other: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) V14 dataload friendly file including deprecated terms
06/07/2018 Other: Questions and answers on adverse-event reporting
06/07/2018 Medicine QA: Questions and answers on preparation, management and assessment of periodic safety update reports (PSURs)
05/07/2018 News and press releases: EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity: some valsartan medicines being recalled across the EU
05/07/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: June 2018
05/07/2018 Overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs
05/07/2018 Human medicines European public assessment report (EPAR): Maci, autologous cultured chondrocytes, Fractures, Cartilage, 27/06/2013, 26/04/2013, 4, Withdrawn
05/07/2018 Report: Stratification of sales data of antimicrobials by species - Data collection protocol 2017
05/07/2018 Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines
05/07/2018 Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development , European Medicines Agency, London, UK, from 03/05/2018 to 04/05/2018
05/07/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: May 2018
05/07/2018 Withdrawn application: Prohippur, sodium benzoate, Date of withdrawal: 03/04/2018, Initial authorisation
05/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Olodaterol (hydrochloride), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0112/2017
05/07/2018 Other: Using Referential and Organisation data in the electronic application form (eAF)
05/07/2018 Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance
05/07/2018 Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance
05/07/2018 Other: Crisis simulation exercise coordinated by European Medicines Agency in October 2017
05/07/2018 Using Organisations Management Service (OMS) data in electronic application forms (eAF) , European Medicines Agency, London, UK, from 27/06/2018 to 27/06/2018
04/07/2018 Other: Informed consent for paediatric clinical trials in Europe 2015
04/07/2018 Periodic safety update single assessment: Fluvastatin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA-00001457-201708
04/07/2018 Periodic safety update single assessment: Fluvastatin: List of nationally authorised medicinal products - PSUSA-00001457-201708
03/07/2018 Presentation: Identity and access management (IAM2) training documentation
03/07/2018 Other: EudraVigilance stakeholder change management plan: integration with the identity and access management (IAM2) project deliverables
03/07/2018 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 25- 28 June 2018
03/07/2018 Periodic safety update single assessment: Quetiapine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002589/201707
03/07/2018 Herbal – European Union herbal monograph: Superseded - Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - First version
02/07/2018 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, Orphan, 23, Authorised
02/07/2018 Herbal medicinal product: Calendulae flos, Calendulae flos, F: Assessment finalised
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