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02/04/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi, canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), 03/07/2014, 6, Authorised (updated)
02/04/2019 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Article 31 referrals, Under evaluation, 13/12/2018, 02/04/2019 (updated)
02/04/2019 Referrals document: Fosfomycin Article-31 referral - Timetable for the procedure (updated)
02/04/2019 Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 17/07/2014, 16, Authorised (updated)
02/04/2019 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 2, Authorised (updated)
02/04/2019 Other: EMA tracking tool: relocation to Amsterdam - Main milestones (updated)
02/04/2019 Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS , European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019
02/04/2019 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 2, Authorised (updated)
02/04/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019 , European Medicines Agency, from 19/02/2019 to 21/02/2019 (updated)
02/04/2019 Minutes: Minutes of the CVMP meeting of 19-21 February 2019
02/04/2019 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 4, Authorised (updated)
02/04/2019 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 8, Authorised (updated)
02/04/2019 Human medicines European public assessment report (EPAR): Silgard, human papillomavirus type 11 L1 protein / human papillomavirus type 16 L1 protein / human papillomavirus type 18 L1 protein / human papillomavirus type 6 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 19/09/2006, 33, Withdrawn (updated)
02/04/2019 Other: List of eligible industry stakeholder organisations (updated)
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-18 : EPAR - Assessment Report - Variation (updated)
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-06 : EPAR - Assessment Report - Variation (updated)
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-12 : EPAR - Assessment Report - Variation (updated)
01/04/2019 Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation
01/04/2019 Minutes: Minutes of the CHMP meeting 28-31 January 2019
01/04/2019 Other: Decision of the Executive Director on rules governing the secondment of national experts to the European Medicines Agency (updated)
01/04/2019 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 12, Authorised (updated)
01/04/2019 Agenda: CHMP ORGAM agenda for the meeting on 18 February 2019
01/04/2019 Regulatory and procedural guideline: EudraVigilance release notes v.1.18 (updated)
01/04/2019 News and press releases: EU recommendations for 2019/2020 seasonal flu vaccine composition
01/04/2019 Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Hyperphosphatemia, Renal Dialysis, 26/08/2014, Additional monitoring, 6, Authorised (updated)
01/04/2019 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2019
01/04/2019 Regulatory and procedural guideline: Commission Regulation (EU) 2019/480 of 22 March 2019 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2019
01/04/2019 News and press releases: Regulatory information – 1.7% increase of fees from 1 April 2019
01/04/2019 Other: Organisation chart: Veterinary Medicines (updated)
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