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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 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 Other: Annual list of specific contracts based on framework contracts – 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report (EPAR): Zinbryta, daclizumab, Multiple Sclerosis, 01/07/2016, Patient safety, Additional monitoring, 8, Withdrawn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 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 13, Authorised
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 Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 20/09/2006, 38, Authorised
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 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 Minutes: Minutes of the CVMP meeting of 23-25 May 2018
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 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 - 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)
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)
26/06/2018 Periodic safety update single assessment: Thiocolchicoside: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/J/0008
26/06/2018 Other: Thiocolchicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0008
26/06/2018 Ibuprofen product-specific bioequivalence guidance
26/06/2018 Scientific guideline: Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance
26/06/2018 Paliperidone product-specific bioequivalence guidance
26/06/2018 Scientific guideline: Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (Rev.1)
26/06/2018 Scientific guideline: Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance
26/06/2018 Overview of comments: Overview of comments received on 'Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance'
26/06/2018 Scientific guideline: Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance
26/06/2018 Overview of comments: Overview of comments received on 'Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance'
26/06/2018 Dimethyl fumarate product-specific bioequivalence guidance
26/06/2018 Scientific guideline: Dimethyl fumarate gastro-resistant capsule 120 mg and 240 mg product-specific bioequivalence guidance
26/06/2018 Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Immunization, 20/09/2007, 31, Authorised
25/06/2018 Other: CAT meetings in 2019, 2020 and 2021
25/06/2018 Veterinary medicines European public assessment report (EPAR): Sevohale (previously known as Sevocalm), sevoflurane, 21/06/2016, Generic, 3, Authorised
25/06/2018 Agenda: Agenda - CHMP agenda of the 25-28 June 2018 meeting
25/06/2018 Human medicines European public assessment report (EPAR): Reagila, cariprazine hydrochloride, Schizophrenia, 13/07/2017, Additional monitoring, 2, Authorised
25/06/2018 Other: Exceptions to the VNeeS format
22/06/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018
22/06/2018 Committee for Advanced Therapies (CAT): 20-22 June 2018 , European Medicines Agency, London, UK, from 20/06/2018 to 22/06/2018
22/06/2018 Summary of opinion: Arti-Cell Forte, chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, 21/06/2018, Positive
22/06/2018 Summary of opinion: Horse Allo 20, allogeneic equine adipose-derived mesenchymal stem cells, 21/06/2018, Negative
22/06/2018 Summary of opinion: Nobivac LeuFel, Feline leukaemia vaccine (inactivated), 21/06/2018, Positive
22/06/2018 Summary of opinion: Leucogen, Feline leukaemia vaccine (inactivated), 21/06/2018, Positive
22/06/2018 Agenda: Agenda - CAT agenda of the 20-22 June 2018 meeting
22/06/2018 Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 18, Authorised
22/06/2018 Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 15, Authorised
22/06/2018 Periodic safety update single assessment: Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/201711
22/06/2018 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201711
22/06/2018 Periodic safety update single assessment: Ezetimibe: List of nationally authorised medicinal products - PSUSA/00001346/201710
22/06/2018 Periodic safety update single assessment: Ketotifen (oral formulations): List of nationally authorised medicinal products - PSUSA/00001813/201710
22/06/2018 News and press releases: Reinforced EU/US collaboration on medicines
22/06/2018 News and press releases: First stem cell-based veterinary medicine recommended for marketing authorisation
22/06/2018 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 4-5 June 2018
22/06/2018 Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 37, Authorised
21/06/2018 News and press releases: Interested in joining the Committee for Advanced Therapies (CAT) to represent patients' associations or clinicians?
21/06/2018 Human medicines European public assessment report (EPAR): Brimica Genuair, aclidinium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 10, Authorised
21/06/2018 Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, Additional monitoring, 15, Authorised
21/06/2018 Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 10, Authorised
21/06/2018 Leaflet: Annual training day for patients and healthcare professionals
20/06/2018 Report: Applications for new human medicines under evaluation by the CHMP: June 2018
20/06/2018 Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, Additional monitoring, 15, Authorised
20/06/2018 Periodic safety update single assessment: Flupirtine: List of nationally authorised medicinal products - PSUSA/00010225/201710
20/06/2018 Periodic safety update single assessment: Atovaquone / proguanil: List of nationally authorised medicinal products - PSUSA/00000266/201710
20/06/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 29 May-01 June 2018
20/06/2018 Human medicines European public assessment report (EPAR): Zepatier, elbasvir, grazoprevir, Hepatitis C, Chronic, 22/07/2016, Additional monitoring, 5, Authorised
19/06/2018 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201710
19/06/2018 RD-ACTION / EMA / DG SANTE workshop: how European Reference Networks can add value to clinical research , European Medicines Agency, London, UK, from 29/05/2018 to 30/05/2018
19/06/2018 Other: List of participants – RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research
19/06/2018 Agenda: Agenda - RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research
19/06/2018 News and press releases: Modernising the orphan designation process
19/06/2018 Newsletter: Human medicines highlights - June 2018
19/06/2018 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Anifrolumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0075/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), W: decision granting a waiver in all age groups for all conditions/indications, P/0061/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Tanezumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride),gabapentin, W: decision granting a waiver in all age groups for all conditions/indications, P/0089/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, W: decision granting a waiver in all age groups for all conditions/indications, P/0063/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype rh.10 carrying the humanNsulfoglucosamine Nsulfoglucosamine sulfohydrolase cDNA (LYS-SAF302), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0078/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Pevonedistat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0054/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin,metformin (hydrochloride), W: decision granting a waiver in all age groups for all conditions/indications, P/0059/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): candesartan (cilexetil),Amlodipine (besylate), W: decision granting a waiver in all age groups for all conditions/indications, P/0093/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Entinostat Polymorph B, W: decision granting a waiver in all age groups for all conditions/indications, P/0087/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Venglustat, W: decision granting a waiver in all age groups for all conditions/indications, P/0066/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): T-cell bispecific antibody targeting carcinoembryonic antigen expressed on tumor cells and CD3 epsilon chain present on T-cells, W: decision granting a waiver in all age groups for all conditions/indications, P/0091/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil (sodium), W: decision granting a waiver in all age groups for all conditions/indications, P/0094/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Niraparib, W: decision granting a waiver in all age groups for all conditions/indications, P/0088/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions/indications, P/0090/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Pemafibrate, W: decision granting a waiver in all age groups for all conditions/indications, P/0073/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): durvalumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0082/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): fluticasone furoate,umeclidinium bromide,vilanterol trifenatate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0076/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0095/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0079/2018
19/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin,Saxagliptin,metformin (hydrochloride), W: decision granting a waiver in all age groups for all conditions/indications, P/0092/2018
19/06/2018 News and press releases: Guidance for pharmaceutical companies to prepare for UK's withdrawal from EU
19/06/2018 Minutes: CHMP ORGAM minutes for the meeting on 22 May 2018
19/06/2018 Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary, 12/04/2006, Biosimilar, 15, Authorised
19/06/2018 Agenda: Agenda - CVMP agenda of the 19-21 June 2018 meeting
19/06/2018 Maximum residue limits (MRL)
19/06/2018 Regulatory and procedural guideline: Committee for orphan medicinal products rules of procedure
18/06/2018 Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting
18/06/2018 Template or form: Template for sections A to E for the scientific part of the application for orphan designation
18/06/2018 Agenda: Programme - 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
18/06/2018 Periodic safety update single assessment: Minoxidil (topical formulation): List of nationally authorised medicinal products - PSUSA/00002067/201710
15/06/2018 Minutes: Minutes of the CHMP meeting 23-26 April 2018
15/06/2018 Report: Medicinal products for human use: monthly figures - May 2018
15/06/2018 Periodic safety update single assessment: Diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001121/201710
15/06/2018 Periodic safety update single assessment: Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201710
15/06/2018 Periodic safety update single assessment: Etifoxine: List of nationally authorised medicinal products - PSUSA/00001321/201710
15/06/2018 Periodic safety update single assessment: Quetiapine: List of nationally authorised medicinal products - PSUSA/00002589/201707
15/06/2018 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 10, Authorised
15/06/2018 Human medicines European public assessment report (EPAR): Protaphane, insulin human, Diabetes Mellitus, 07/10/2002, 16, Authorised
15/06/2018 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018
15/06/2018 Human medicines European public assessment report (EPAR): Episalvan, betulae cortex dry extract  (5-10 : 1); extraction solvent: n-heptane 95% (w/w), Wounds and Injuries, Wound Healing, 14/01/2016, Additional monitoring, 3, Authorised
15/06/2018 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 27, Authorised
14/06/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, The Netherlands , BCN Amsterdam Arena, Amsterdam, The Netherlands, from 10/12/2018 to 12/12/2018
14/06/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, Germany , one-by-one EDV-GmbH, Berlin, Germany, from 24/09/2018 to 26/09/2018
14/06/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris, France , Châteauform' College, Paris, France, from 19/11/2018 to 21/11/2018
14/06/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna, Austria , AGES - Vienna, Austria, from 01/10/2018 to 02/10/2018
14/06/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, San Marino, Republic of San Marino , Grand Hotel San Marino, Republic of San Marino, from 07/11/2018 to 09/11/2018
14/06/2018 The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , European Medicines Agency, London, UK, from 05/12/2018 to 07/12/2018
14/06/2018 The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , European Medicines Agency, London, UK, from 12/11/2018 to 14/11/2018
14/06/2018 Report: Report from the CAT expert meeting on scientific and regulatory considerations for adeno-associated viral vector (AAV)-based gene therapy
14/06/2018 The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , European Medicines Agency, London, UK, from 08/10/2018 to 10/10/2018
14/06/2018 The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , European Medicines Agency, London, UK, from 17/09/2018 to 19/09/2018
14/06/2018 Orphan designation: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt for the: Treatment of congenital alpha-1 antitrypsin deficiency, 20/03/2013, Positive
14/06/2018 Orphan designation: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt for the: Treatment of primary ciliary dyskinesia, 27/02/2017, Positive
14/06/2018 News and press releases: IT systems unavailable from 15 to 18 June 2018
14/06/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: May 2018
14/06/2018 Orphan designation: Entospletinib for the: Treatment of acute myeloid leukaemia, 16/10/2017, Positive
13/06/2018 eXtended EudraVigilance medicinal product dictionary face-to-face training course , European Medicines Agency, London, UK, from 15/11/2018 to 16/11/2018
13/06/2018 eXtended EudraVigilance medicinal product dictionary face-to-face training course , European Medicines Agency, London, UK, from 20/09/2018 to 21/09/2018
13/06/2018 Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018
13/06/2018 Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018
13/06/2018 Human medicines European public assessment report (EPAR): Plenadren, hydrocortisone, Adrenal Insufficiency, 03/11/2011, Orphan, 10, Authorised
13/06/2018 Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3
13/06/2018 Human medicines European public assessment report (EPAR): Amyvid, florbetapir (18F), Radionuclide Imaging, 14/01/2013, 12, Authorised
13/06/2018 Orphan designation: Ivosidenib for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive
13/06/2018 Orphan designation: 2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (remdesivir) for the: Treatment of Ebola virus disease, 17/02/2016, Positive
13/06/2018 Orphan designation: Sialic acid (also known as aceneuramic acid) for the: Treatment of GNE myopathy, 16/10/2015, Withdrawn
13/06/2018 Orphan designation: Synthetic double-stranded RNA oligonucleotide specific to hydroxyacid oxidase 1 gene for the: Treatment of primary hyperoxaluria type 1, 28/07/2015, Withdrawn
13/06/2018 Orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor for the: Treatment of retinitis pigmentosa, 24/01/2013, Positive
13/06/2018 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran) for the: Treatment of haemophilia B, 29/07/2014, Positive
13/06/2018 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran) for the: Treatment of haemophilia A, 29/07/2014, Positive
13/06/2018 Orphan designation: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel) for the: Treatment of B-lymphoblastic leukaemia/lymphoma, 29/04/2014, Positive
13/06/2018 Orphan designation: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel) for the: Treatment of diffuse large B-cell lymphoma, 14/10/2016, Positive
13/06/2018 Orphan designation: Mexiletine hydrochloride for the: Treatment of myotonic disorders, 19/11/2014, Positive
13/06/2018 Orphan designation: Aztreonam lysinate (inhalation use) for the: Treatment of Gram-negative bacterial lung infection in cystic fibrosis, 21/06/2004, Positive
13/06/2018 Human medicines European public assessment report (EPAR): Twynsta, telmisartan, amlodipine, Hypertension, 07/10/2010, 9, Authorised
13/06/2018 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the: Treatment of post-polycythaemia vera myelofibrosis, 26/11/2010, Positive
13/06/2018 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the: Treatment of post-essential thrombocythaemia myelofibrosis, 26/11/2010, Positive
13/06/2018 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the: Treatment of primary myelofibrosis, 01/10/2010, Positive
13/06/2018 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, Additional monitoring, 3, Authorised
13/06/2018 Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 26, Authorised
13/06/2018 Human medicines European public assessment report (EPAR): Eporatio, epoetin theta, Kidney Failure, Chronic, Anemia, Cancer, 29/10/2009, 11, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma, Glioblastoma, 28/01/2010, Generic, 17, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Cuprymina, copper (64Cu) chloride, Radionuclide Imaging, 23/08/2012, Additional monitoring, 6, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Incresync, alogliptin, pioglitazone, Diabetes Mellitus, Type 2, 19/09/2013, 6, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 14, Authorised
12/06/2018 Orphan designation: A highly purified formulation of Staphylococcus aureus protein A for the: Treatment of immune thrombocytopenia, 09/10/2015, Positive
12/06/2018 Orphan designation: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl ethyl ester))-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-PEG1500-ester] for the: Treatment of dengue, 16/01/2014, Positive
12/06/2018 Orphan designation: Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor for the: Treatment in haematopoietic stem cell transplantation, 12/01/2017, Positive
12/06/2018 Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi, busulfan, Hematopoietic Stem Cell Transplantation, 22/09/2014, Generic, 4, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting, Postoperative Nausea and Vomiting, Cancer, 11/11/2003, 24, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 20, Authorised
12/06/2018 Human medicines European public assessment report (EPAR): Zutectra, human hepatitis-B immunoglobulin, Immunization, Passive, Hepatitis B, Liver Transplantation, 30/11/2009, 12, Authorised
11/06/2018 Minutes: Minutes of the PRAC meeting 9-12 April 2018
11/06/2018 Periodic safety update single assessment: Dexamfetamine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/201709
11/06/2018 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201709
11/06/2018 Other: Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria
11/06/2018 Management Board meeting: 15 March 2018 , European Medicines Agency, London, UK, from 15/03/2018 to 15/03/2018
11/06/2018 Regulatory and procedural guideline: Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities
11/06/2018 Agenda: Agenda and list of speakers - Public Hearing: quinolone and fluoroquinolone medicines
11/06/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC
11/06/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC meeting
11/06/2018 Human medicines European public assessment report (EPAR): Signifor, pasireotide, Acromegaly, Pituitary ACTH Hypersecretion, 24/04/2012, Orphan, 11, Authorised
11/06/2018 Committee for Herbal Medicinal Products (HMPC): 4-5 June 2018 , European Medicines Agency, London, UK, from 04/06/2018 to 05/06/2018
11/06/2018 Agenda: Agenda - HMPC agenda of the 4-5 June 2018 meeting
11/06/2018 Other: Management Board meeting dates 2019 – 2021
11/06/2018 Agenda: Agenda - PRAC draft agenda of meeting 11-14 June 2018
11/06/2018 Other: Outcome of written procedures during the period 22 February 2018 to 21 May 2018
11/06/2018 Report: Summary of transfers of appropriations in budget 2018 - Management Board meeting of 6-7 June 2018
11/06/2018 Human medicines European public assessment report (EPAR): Mixtard, insulin human, Diabetes Mellitus, 07/10/2002, 17, Authorised
11/06/2018 Guidance on good manufacturing practice and good distribution practice: Questions and answers
11/06/2018 Human medicines European public assessment report (EPAR): Starlix, nateglinide, Diabetes Mellitus, Type 2, 03/04/2001, 13, Authorised
08/06/2018 Other: EudraVigilance Operational Plan - milestones 2018 to 2020
08/06/2018 Orphan designation: Para-aminosalicylic acid for the: Treatment of tuberculosis, 17/12/2010, Positive
08/06/2018 Orphan designation: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine for the: Treatment of neurotrophic keratitis, 16/12/2014, Positive
08/06/2018 EudraVigilance
08/06/2018 Orphan designation: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for the: Ttreatment of gastrointestinal stromal tumours, 12/10/2017, Positive
08/06/2018 Human medicines European public assessment report (EPAR): Actraphane, insulin human, Diabetes Mellitus, 07/10/2002, 17, Authorised
08/06/2018 Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018 , European Medicines Agency, London, UK, from 23/04/2018 to 26/04/2018
08/06/2018 Minutes: CHMP ORGAM minutes for the meeting on 16 April 2018
08/06/2018 SPOR user registration
08/06/2018 Orphan designation: (Manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-) for the: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy, 31/01/2008, Positive
08/06/2018 Orphan designation: Mepolizumab for the: Treatment of Churg-Strauss syndrome, 12/03/2013, Positive
08/06/2018 Orphan designation: Mepolizumab for the: Treatment of hypereosinophilic syndrome, 29/07/2004, Positive
08/06/2018 Opinion/decision on a Paediatric investigation plan (PIP): Cadazolid, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0186/2016
08/06/2018 Other: Cadazolid - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
08/06/2018 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, 23/08/2012, 16, Authorised
08/06/2018 Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections, Streptococcal Infections, Staphylococcal Infections, Gram-Negative Bacterial Infections, Surgical Wound Infection, Pneumonia, Bacterial, 18/04/2002, 21, Authorised
08/06/2018 Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/05/2018, Generic, Authorised
07/06/2018 News and press releases: Highlights of 100th Management Board meeting: June 2018
07/06/2018 Referral: Valproate and related substances , sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide , Absenor,Convival Chrono,Convulex,Delepsine,Depakin,Depakine,Depakote,Depamag,Depamide,Deprakine,Diplexil,Dipromal,Epilim,Episenta,Epival,Ergenyl,Espa-Valept,Hexaquin,Kentlim,Leptilan,Micropakine L.P.,Orfiril,Petilin,Valepil,Valhel PR,Valpal,Valpro and Valprolek, Article 31 referrals, European Commission final decision, 21/03/2018, 31/05/2018, 07/06/2018
07/06/2018 Periodic safety update single assessment: Permethrin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002355/201707
07/06/2018 Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/201707
07/06/2018 Periodic safety update single assessment: Finasteride: List of nationally authorised medicinal products - PSUSA/00001392/201708
07/06/2018 Periodic safety update single assessment: Finasteride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001392/201708
07/06/2018 Periodic safety update single assessment: Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/201708