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31/08/2018 News and press releases: Development of medicines for rare diseases
31/08/2018 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 50, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 30, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 9, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Luveris, lutropin alfa, Ovulation Induction, Infertility, Female, 29/11/2000, 19, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Hypertension, 29/09/2010, Generic, 9, Authorised
31/08/2018 Periodic safety update single assessment: Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712
31/08/2018 Periodic safety update single assessment: Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712
31/08/2018 Other: Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions
31/08/2018 Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 13, Authorised
31/08/2018 Periodic safety update single assessment: Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711
31/08/2018 Periodic safety update single assessment: Rosuvastatin: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002664/201711
31/08/2018 Human medicines European public assessment report (EPAR): Zalmoxis, Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, 18/08/2016, Orphan, Additional monitoring, Conditional approval, 1, Authorised
30/08/2018 Agenda: Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
29/08/2018 Availability of medicines
29/08/2018 News and press releases: Towards improving the availability of medicines in the EU
29/08/2018 Other: EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use
29/08/2018 Recommendation on medication errors: Guide to be given to prescribers to ensure Amglidia is used correctly
29/08/2018 Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 32, Authorised
28/08/2018 News and press releases: Fostering medicines for children
28/08/2018 Minutes: Minutes - PDCO minutes of the 24-27 July 2018 meeting
28/08/2018 Agenda: Agenda - PDCO agenda of the 21-24 August 2018 meeting
24/08/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, Portugal , Lisbon, Portugal, from 26/11/2018 to 28/11/2018
24/08/2018 Agenda: Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, October 2018
24/08/2018 Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Glioma, 07/09/2007, Orphan, 4, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): Duzallo, allopurinol, lesinurad, Gout, 23/08/2018, Additional monitoring, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): HyQvia, Human normal immunoglobulin, Immunologic Deficiency Syndromes, 16/05/2013, Additional monitoring, 12, Authorised
24/08/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, Spain , MSL Formacion, Madrid, Spain, from 15/10/2018 to 18/10/2018
24/08/2018 Agenda: Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, October 2018
24/08/2018 Human medicines European public assessment report (EPAR): Temozolomide Sandoz, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 15, Authorised
24/08/2018 Veterinary medicines European public assessment report (EPAR): VarroMed, oxalic acid dihydrate, formic acid, 02/02/2017, 1, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Cholestasis, Vitamin E Deficiency, 23/07/2009, Additional monitoring, Exceptional circumstances, 12, Authorised
23/08/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts
23/08/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene
23/08/2018 Management Board meeting: 6-7 June 2018 , European Medicines Agency, London, UK, from 06/06/2018 to 07/06/2018
23/08/2018 Minutes: Minutes of the 100th meeting of the Management Board: 6-7 June 2018
23/08/2018 Minutes: Minutes of the CAT meeting 18-20 April 2018
23/08/2018 Minutes: Minutes of the CAT meeting 23-25 May 2018
23/08/2018 Availability of veterinary medicines
23/08/2018 News and press releases: European Medicines Agency closed 27 August 2018
23/08/2018 Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Melanoma, 17/02/2012, 18, Authorised
22/08/2018 News and press releases: Keeping medicines safe
22/08/2018 Orphan designation: Omaveloxolone for the: 27/06/2018, Positive
22/08/2018 Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene for the: Treatment of mucopolysaccharidosis type I, 27/06/2018, Positive