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31/10/2018 Minutes: CHMP ORGAM minutes for the meeting on 10 September 2018
31/10/2018 Agenda: CHMP ORGAM agenda for the meeting on 10 September 2018
31/10/2018 Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018 , European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018
31/10/2018 Shortages catalogue
31/10/2018 News and press releases: Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018
31/10/2018 Human medicines European public assessment report (EPAR): Zoledronic acid Actavis, zoledronic acid monohydrate, Fractures, Bone, 20/04/2012, Generic, 11, Authorised
31/10/2018 News and press releases: Working with stakeholders to improve availability of medicines in the EU
30/10/2018 Scientific guideline: Overview of comments received on ' Reflection paper on the use of extrapolation in the development of medicines for paediatrics ' (EMA/189724/2018) - Revision 1
30/10/2018 Scientific guideline: Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1
30/10/2018 Other: Letter of support for Model-based CT enrichment tool for CTs in aMCI
30/10/2018 Agenda: Agenda - COMP agenda of the 6-8 November 2018 meeting
30/10/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: August-September 2018
30/10/2018 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2018
30/10/2018 Extrapolation of efficacy and safety in paediatric medicine development
30/10/2018 Technical Anonymisation Group (TAG): First meeting , European Medicines Agency, London, UK, from 29/11/2017 to 30/11/2017
30/10/2018 Minutes: Minutes - Technical Anonymisation Group (TAG): First meeting
30/10/2018 Agenda: Agenda - Technical Anonymisation Group (TAG): First meeting
30/10/2018 News and press releases: EMA closed 1-2 November 2018
29/10/2018 Agenda: Agenda - PRAC draft agenda of meeting 29-31 October 2018
29/10/2018 Periodic safety update single assessment: Amantadine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000126/201801
29/10/2018 Periodic safety update single assessment: Amantadine: List of nationally authorised medicinal products - PSUSA/00000126/201801
29/10/2018 Periodic safety update single assessment: Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201802
29/10/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC meeting
29/10/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC
29/10/2018 Workshop on the development of antimicrobial medicinal products for paediatric patients , European Medicines Agency, London, UK, from 21/06/2018 to 22/06/2018
26/10/2018 Regulatory and procedural guideline: Quick interactive guide to EudraVigilance registration process
26/10/2018 News and press releases: EMA experts awarded for excellence in standards development
26/10/2018 Minutes: Minutes of the PRAC meeting 3-6 September 2018
26/10/2018 Report: Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol
26/10/2018 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018
25/10/2018 Periodic safety update single assessment: Fenoterol / ipratropium: List of nationally authorised medicinal products - PSUSA/00001367/201802
25/10/2018 Template or form: Template - Orphan designation sponsor’s name and/or address change notification letter
25/10/2018 Agenda: Agenda - Info day for micro, small and medium-sized enterprises: regulatory toolbox for medicines and combined devices developers
25/10/2018 Human medicines European public assessment report (EPAR): Truberzi, eluxadoline, Irritable Bowel Syndrome, Diarrhea, 19/09/2016, Additional monitoring, 4, Authorised
25/10/2018 Periodic safety update single assessment: Lormetazepam: List of nationally authorised medicinal products for maintenance - PSUSA/00001910/201712
25/10/2018 Periodic safety update single assessment: Valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide...: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003090/201801
25/10/2018 Periodic safety update single assessment: Valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide, valproate bismuth, calcium valproate, valproate magnesium: List of nationally authorised medicinal products - PSUSA/00003090/201801
25/10/2018 Periodic safety update single assessment: Dacarbazine: List of nationally authorised medicinal products - PSUSA/00000919/201802
25/10/2018 Periodic safety update single assessment: Mivacurium: List of nationally authorised medicinal products - PSUSA/00002077/201801
25/10/2018 Periodic safety update single assessment: Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201803
24/10/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: October 2018
24/10/2018 Orphan designation: Recombinant human monoclonal antibody against activin receptor type IIB for the: Treatment of inclusion body myositis, 09/08/2012, Withdrawn
24/10/2018 Orphan designation: Maytansinoid-conjugated human monoclonal antibody against mesothelin (anetumab ravtansine) for the: Treatment of malignant mesothelioma, 06/12/2012, Withdrawn
24/10/2018 Orphan designation: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene for the: Treatment of retinitis pigmentosa, 22/02/2018, Positive
24/10/2018 Orphan designation: Recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) for the: Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009, Positive
24/10/2018 Orphan designation: Miransertib for the: Treatment of Proteus syndrome, 21/03/2018, Positive
24/10/2018 Orphan designation: Bitopertin for the: Treatment of beta thalassaemia intermedia and major, 16/10/2017, Withdrawn
24/10/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 15-18 October 2018
24/10/2018 Regulatory and procedural guideline: PRIME eligibility requests: 2019 deadlines for submission and timetable for assessment
23/10/2018 Orphan designation: autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1 for the: Treatment of soft tissue sarcoma, 14/07/2016, Positive
23/10/2018 Orphan designation: melatonin for the: Treatment of Smith-Magenis syndrome, 14/10/2016, Positive
23/10/2018 Orphan designation: melatonin for the: Treatment of necrotising enterocolitis, 01/08/2016, Positive
23/10/2018 Orphan designation: melatonin for the: Treatment of neonatal sepsis, 27/06/2016, Positive
23/10/2018 Orphan designation: sildenafil citrate for the: treatment of postcardiotomy right ventricular failure, 26/11/2010, Positive
23/10/2018 Orphan designation: Pegylated recombinant human interleukin-10 for the: Treatment of pancreatic cancer, 12/12/2016, Positive
23/10/2018 Orphan designation: Dinaciclib for the: Treatment of chronic lymphocytic leukaemia, 27/09/2011, Positive
23/10/2018 Periodic safety update single assessment: Aldesleukin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000076/201712
23/10/2018 Periodic safety update single assessment: Aldesleukin: List of nationally authorised medicinal products - PSUSA/00000076/201712
23/10/2018 Agenda: Agenda - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025
23/10/2018 Veterinary medicines European public assessment report (EPAR): Letifend, recombinant protein Q from Leishmania infantum MON-1, 20/04/2016, 5, Authorised
22/10/2018 Agenda: Agenda - Heads of Medicines Agencies / European Medicines Agency technical meeting on availability of authorised human medicines
22/10/2018 Heads of Medicines Agencies / European Medicines Agency technical meeting on availability of authorised human medicines , European Medicines Agency, London, UK, from 08/11/2018 to 08/11/2018
22/10/2018 Orphan designation: Lenvatinib for the: Treatment of hepatocellular carcinoma, 19/03/2015, Withdrawn
22/10/2018 Orphan designation: Lenvatinib for the: Treatment of papillary thyroid cancer, 26/04/2013, Withdrawn
22/10/2018 Orphan designation: Lenvatinib for the: Treatment of follicular thyroid cancer, 26/04/2013, Withdrawn
22/10/2018 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
22/10/2018 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration
22/10/2018 Orphan designation: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab) for the: Treatment of X-linked hypophosphataemia, 15/10/2014, Positive
19/10/2018 Minutes: Minutes of the CVMP meeting of 11-13 September 2018
19/10/2018 Minutes: Minutes - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting
19/10/2018 Agenda: Agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting
19/10/2018 European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, product, organisation and referential data (SPOR) task force meeting , European Medicines Agency, London, UK, from 22/06/2018 to 22/06/2018
19/10/2018 European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, product, organisation and referential data (SPOR) task force meeting , European Medicines Agency, London, UK, from 23/03/2018 to 23/03/2018
19/10/2018 Minutes: Minutes - European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting
19/10/2018 Agenda: Agenda – European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting
19/10/2018 Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone palmitate, Schizophrenia, 05/12/2014, 8, Authorised
19/10/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018
19/10/2018 News and press releases: New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
19/10/2018 News and press releases: First treatment for rare inherited muscle contraction disorders
19/10/2018 Annex to CHMP highlights: Overview of (invented) names reviewed in September 2018 by the Name Review Group (NRG)
19/10/2018 Annex to CHMP highlights: Start of community reviews - CHMP meeting of 15-18 October 2018
19/10/2018 News and press releases: First vaccine for prevention of dengue