What's new

RSS
Date Content
30/06/2020 Procurement activities 2019
30/06/2020 Other: Annual list of contract modifications 2019
30/06/2020 Other: Annual list of contractors 2019 - contract values Euro 15,000 - 143,999
30/06/2020 Other: Annual list of specific contracts based on framework contracts - 2019
30/06/2020 News and press releases: EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2020
29/06/2020 Other: Mandate, objectives and rules of procedure for the CVMP Immunologicals Working Party (IWP)
29/06/2020 Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
29/06/2020 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, Additional monitoring, 4, Authorised
29/06/2020 Minutes: Minutes of the CAT meeting 18-20 May 2020
29/06/2020 Veterinary medicines European public assessment report (EPAR): Stronghold Plus, selamectin, sarolaner, 08/02/2017, 3, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 27, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 23, Authorised
26/06/2020 Other: Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
26/06/2020 Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
26/06/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020
26/06/2020 News and press releases: New medicine for cystic fibrosis patients
26/06/2020 News and press releases: New treatment to enable kidney transplant in highly sensitised patients
26/06/2020 Withdrawn application: Zemdri, Date of withdrawal: 16/06/2020, Initial authorisation
26/06/2020 Annex to CHMP highlights: Start of Union reviews - CHMP meeting of 22-25 June 2020
26/06/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 June 2020
26/06/2020 Orphan designation: Ciprofloxacin for the: Treatment of cystic fibrosis, 24/07/2009, Positive
26/06/2020 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 6, Authorised
26/06/2020 Veterinary medicines European public assessment report (EPAR): Loxicom, meloxicam, 10/02/2009, Generic, 15, Authorised
26/06/2020 Other: Emerging safety issues (ESI) contact points at the national competent authority (NCA) level
26/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis ColiClos, Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT, 14/06/2012, 5, Authorised
26/06/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 18/05/2020 to 20/05/2020
26/06/2020 Minutes: Minutes of the CVMP meeting of 18-20 May 2020
25/06/2020 News and press releases: First COVID-19 treatment recommended for EU authorisation
25/06/2020 News and press releases: Emer Cooke nominated as new EMA Executive Director
25/06/2020 How to prepare and review a summary of product characteristics
25/06/2020 Presentation: Presentation - Section 4.8: Undesirable effects
25/06/2020 Other: Scientific guidelines with summary-of-product-characteristics recommendations
25/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2020
25/06/2020 Agenda: Agenda - Extraordinary Management Board meeting to nominate a new EMA Executive Director: 25 June 2020
25/06/2020 Minutes: Minutes of the COMP meeting 18-20 May 2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 21/10/2020 to 23/10/2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 14/12/2020 to 16/12/2020
25/06/2020 Supply shortage: Cinryze (C1 inhibitor, human) supply shortage
25/06/2020 Other: List of eligible industry stakeholder organisations