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11/07/2018 Human medicines European public assessment report (EPAR): Mimpara, cinacalcet hydrochloride, Hypercalcemia, Parathyroid Neoplasms, Hyperparathyroidism, 22/10/2004, 20, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 19, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 23/02/1998, 32, Authorised
10/07/2018 News and press releases: EMA identifies gaps in industry preparedness for Brexit
10/07/2018 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 6, Authorised
10/07/2018 Minutes: Minutes - PDCO minutes of the 24-27 April 2018 meeting
10/07/2018 Other: Table of European Paediatric Research Nurse Networks and Groups provided by the Enpr-EMA Research Nurse Training Group
10/07/2018 Other: Sample eligibility form - Healthcare professionals
10/07/2018 Other: Sample eligibility form - Patients and consumers
10/07/2018 Report: Annual activity report 2017
10/07/2018 Newsletter: Human medicines highlights - July 2018
10/07/2018 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic, 08/06/2001, 40, Authorised
10/07/2018 Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 41, Authorised
10/07/2018 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 14, Authorised
10/07/2018 Human medicines European public assessment report (EPAR): Axura, memantine hydrochloride, Alzheimer Disease, 17/05/2002, 24, Authorised
09/07/2018 Agenda: Agenda - PRAC draft agenda of meeting 9-12 July 2018
09/07/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC
09/07/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC meeting
09/07/2018 Minutes: Minutes of the PRAC meeting 14-17 May 2018
06/07/2018 Other: Timetable: Paediatric art. 46 submission - ATMP
06/07/2018 Other: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP
06/07/2018 Other: Timetable: Post-authorisation measure (PAM) assessed by Pharmacovigilance Risk Assessment Committee (PRAC)
06/07/2018 Other: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission
06/07/2018 Other: Timetable: Post-authorisation measure (PAM) assessed by CAT
06/07/2018 Other: Timetable: Post-authorisation measure (PAM) assessed by Committee for Medicinal Products for Human Use (CHMP)
06/07/2018 Agenda: Agenda - PDCO agenda of the 26-29 June 2018 meeting
06/07/2018 Leaflet: EMA supporting medicines development
06/07/2018 Other: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans
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 Human medicines European public assessment report (EPAR): Cayston, aztreonam lysine, Cystic Fibrosis, Respiratory Tract Infections, 21/09/2009, Orphan, 16, Authorised
04/07/2018 Other: Informed consent for paediatric clinical trials in Europe 2015
04/07/2018 Human medicines European public assessment report (EPAR): Pantoloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 14, Authorised
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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