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29/06/2018 News and press releases: First two CAR-T cell medicines recommended for approval in the European Union
29/06/2018 Summary of opinion: RoActemra, tocilizumab, 28/06/2018, Positive
29/06/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018
29/06/2018 Summary of opinion: CHMP post-authorisation summary of positive opinion for Inovelon
29/06/2018 News and press releases: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
29/06/2018 Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry
29/06/2018 Periodic safety update single assessment: Carvedilol / ivabradine: List of nationally authorised medicinal products - PSUSA/00010586/201711
29/06/2018 Orphan designation: 3,4-diaminopyridine phosphate for the: Treatment of Lambert-Eaton myasthenic syndrome, 19/12/2002, Positive
29/06/2018 Orphan designation: Larotrectinib for the: Treatment of salivary gland cancer, 21/03/2018, Positive
29/06/2018 Orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib) for the: Treatment of soft tissue sarcoma, 11/01/2016, Positive
28/06/2018 Procurement activities 2017
28/06/2018 Other: Annual list of specific contracts based on framework contracts – 2017
28/06/2018 Other: Annual list of contractors 2017 - contract values: €15,000 - €134,999
28/06/2018 Other: Annual list of contract modifications 2017
28/06/2018 Minutes: Minutes of the COMP meeting of 17-19 April 2018
28/06/2018 Orphan designation: Letermovir for the: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity, 06/06/2012, Positive
28/06/2018 Orphan designation: (S)-{8-Fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid (letermovir) for the: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 15/04/2011, Positive
28/06/2018 Human medicines European public assessment report (EPAR): Zinbryta, daclizumab, Multiple Sclerosis, 01/07/2016, Patient safety, Additional monitoring, 8, Withdrawn
27/06/2018 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting , European Medicines Agency, London, UK, from 17/04/2018 to 18/04/2018
27/06/2018 Other: List of participants - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
27/06/2018 Minutes: Meeting summary - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
27/06/2018 Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived mesenchymal stem cells
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: allogenic mesenchymal stem cells isolated from umbilical cord
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: allogeneic human neural stem cells derived from foetal central nervous system
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: allogeneic pancreatic islets encapsulated by elastin-like recombinamers
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: expanded autologous auricular chondrocytes
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: autologous enriched CD31+ cell fraction from peripheral blood
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: ex vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast
27/06/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived human mesenchymal stem cells
27/06/2018 Committee for Medicinal Products for Veterinary Use (CVMP): 23-25 May 2018 , European Medicines Agency, London, UK, from 23/05/2018 to 25/05/2018
27/06/2018 Minutes: Minutes of the CVMP meeting of 23-25 May 2018
27/06/2018 Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product
27/06/2018 Template or form: Appendix V - Adverse-drug-reaction reporting details
27/06/2018 Report: Stakeholder engagement report 2017
27/06/2018 Report: Annexes - Stakeholder engagement annual report 2017
27/06/2018 Other: Timetable: Type IB variation requiring linguistic review
27/06/2018 Other: Timetable: Type II variation and worksharing application weekly assessment
27/06/2018 Scientific guideline: Draft lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
27/06/2018 Scientific guideline: Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance
27/06/2018 Scientific guideline: Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance
27/06/2018 Scientific guideline: Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance
27/06/2018 Scientific guideline: Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance
27/06/2018 Presentation: Presentation - Trends in marketing authorisation applications - EMA's PCWP and HCPWP joint meeting (Alexios M. Skarlatos)
27/06/2018 Presentation: Presentation - Mapping EU initiatives on electronic product information - EMA's PCWP and HCPWP joint meeting (Cà©sar Hernà¡ndez Garcà­a)
27/06/2018 Presentation: Presentation - European Medicines Agency (EMA) on social media- EMA's PCWP and HCPWP joint meeting (Monika Benstetter)
27/06/2018 Presentation: Presentation - Digital Media and Health Topic Group - EMA's PCWP and HCPWP joint meeting (Kathi Apostolidis)
27/06/2018 Presentation: Presentation - Real World Evidence (RWE) – what have we learned recently at EMA? - EMA's PCWP and HCPWP joint meeting (Kieran Breen, Jamie Wilkinson, Courtney Coleman, Isabel Proano, Sofia Marcha, Birgit Bauer)
27/06/2018 Presentation: Presentation - Implementation of Clinical Trial Regulation – Update on EU-CT portal and database - EMA's PCWP and HCPWP joint meeting (Laura Pioppo)
27/06/2018 Presentation: Presentation - Digital Media and Health Topic Group- EMA's PCWP and HCPWP joint meeting (Caroline Morton-Gallagher)
27/06/2018 Presentation: Presentation - EMA Clinical Data Publication (CDP) - EMA's PCWP and HCPWP joint meeting (Karen Quigley)
27/06/2018 Presentation: Presentation - Innovative medicines initiative (IMI) WEB-RADR project - EMA's PCWP and HCPWP joint meeting (Cà©sar Hernà¡ndez Garcà­a)
27/06/2018 Presentation: Presentation - EMA experience on mHealth technology - EMA's PCWP and HCPWP joint meeting (Francesca Cerreta)
27/06/2018 Presentation: Presentation - Towards electronic product information in the EU - EMA action plan related to the European Commission’s recommendations on product information - EMA's PCWP and HCPWP joint meeting (A. Skarlatos)
27/06/2018 Presentation: Presentation - Regulatory Perspective on Real World Evidence (RWE) in scientific advice - EMA's PCWP and HCPWP joint meeting (Jane Moseley)
27/06/2018 Presentation: Presentation - European Multiple Sclerosis Platform (EMSP) - EMA's PCWP and HCPWP joint meeting (Andreea Antonovici)
27/06/2018 Presentation: Presentation - Real world evidence (RWE) – an introduction; how is it relevant for the medicines regulatory system? - EMA's PCWP and HCPWP joint meeting (Hans-Georg Eichler)
27/06/2018 Presentation: Presentation - Supporting the European Immunization Week - EMA's PCWP and HCPWP joint meeting (Camelia Enachioiu)
27/06/2018 Presentation: Presentation - Enhancing evidence generation across the product life cycle: learnings from a series of workshops - EMA's PCWP and HCPWP joint meeting (Alison Cave)
27/06/2018 Presentation: Presentation - EMA Technical Anonymisation Group (TAG) - EMA's PCWP and HCPWP joint meeting (Monica Dias)