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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 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 9, Authorised
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 Human medicines European public assessment report (EPAR): Desloratadine Actavis, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 13/01/2012, 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 Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Carcinoma, Non-Small-Cell Lung, 21/09/2018, Additional monitoring, Authorised
30/10/2018 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major, 19/06/2015, Generic, 7, Authorised
30/10/2018 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Orphan, Additional monitoring, 41, Authorised
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 Human medicines European public assessment report (EPAR): Vyxeos, daunorubicin hydrochloride / cytarabine, Leukemia, Myeloid, Acute, 23/08/2018, Orphan, Authorised
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
26/10/2018 ICH Q3C (R7) Residual solvents
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 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, Additional monitoring, 11, 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
24/10/2018 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, 24, Authorised
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 Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, Generic, 4, Authorised
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 Human medicines European public assessment report (EPAR): Dukoral, recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera, Immunization, 28/04/2004, 12, Authorised
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
23/10/2018 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 10, 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: Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports
22/10/2018 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
22/10/2018 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
22/10/2018 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances
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
18/10/2018 Agenda: Agenda - Risk management plan information day
18/10/2018 Other: Update on the pilot of signal detection in EudraVigilance by marketing authorisation holders
18/10/2018 Report: Summary of transfers of appropriations in budget 2018 - Management Board meeting of 4 October 2018
18/10/2018 Other: Outcome of written procedures during the period 22 May 2018 to 10 September 2018
18/10/2018 Report: Medicinal products for human use: monthly figures - September 2018
18/10/2018 Management Board meeting: 4 October 2018 , European Medicines Agency, London, UK, from 04/10/2018 to 04/10/2018
18/10/2018 Orphan designation: Mogamulizumab for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated), 11/01/2012, Positive
18/10/2018 Orphan designation: Inebilizumab for the: Treatment of neuromyelitis optica spectrum disorders, 20/03/2017, Positive
18/10/2018 Orphan designation: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone for the: Treatment of Rett syndrome, 19/02/2014, Positive
18/10/2018 Orphan designation: branaplam for the: Treatment of spinal muscular atrophy, 16/04/2018, Positive
18/10/2018 Orphan designation: ofatumumab for the: Treatment of chronic lymphocytic leukaemia, 07/11/2008, Withdrawn
18/10/2018 Orphan designation: Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene for the: Treatment of haemophilia A, 21/03/2016, Positive
18/10/2018 Orphan designation: Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene for the: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency, 26/08/2005, Positive
18/10/2018 Orphan designation: icatibant acetate for the: Treatment of angioedema, 18/02/2003, Positive
18/10/2018 News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018
18/10/2018 Report: Applications for new human medicines under evaluation by the CHMP: October 2018
18/10/2018 Report: Applications for new human medicines under evaluation by the CHMP: September 2018
18/10/2018 Other: Explanatory note on pharmacovigilance fees payable to the European Medicines Agency
18/10/2018 Committee for Advanced Therapies (CAT): 10-12 October 2018 , European Medicins Agency, London, UK, from 10/10/2018 to 12/10/2018
18/10/2018 Agenda: Agenda - CAT agenda of the 10-12 October 2018 meeting
18/10/2018 Agenda: Agenda - CAT agenda of the 10-12 October 2018 meeting
17/10/2018 Periodic safety update single assessment: Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201803
17/10/2018 Periodic safety update single assessment: Ciprofloxacin (topical use): List of nationally authorised medicinal products - PSUSA/00000776/201801
17/10/2018 Herbal medicinal product: Agni casti fructus, Agni casti fructus, F: Assessment finalised
17/10/2018 Herbal medicinal product: Oenotherae biennis oleum , Oenotherae biennis oleum, F: Assessment finalised
17/10/2018 News and press releases: Shaping regulatory science to 2025
17/10/2018 Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0197/2015
17/10/2018 Human medicines European public assessment report (EPAR): Xeplion, paliperidone palmitate, Schizophrenia, 04/03/2011, 13, Authorised
17/10/2018 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Isoflurane
17/10/2018 Human medicines European public assessment report (EPAR): Invega, paliperidone, Schizophrenia, Psychotic Disorders, 24/06/2007, 16, Authorised
17/10/2018 Human medicines European public assessment report (EPAR): Ivabradine Zentiva, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 11/11/2016, Generic, 1, Authorised
16/10/2018 Maximum Residue Limits - Report: Isoflurane (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
16/10/2018 Periodic safety update single assessment: Lomustine: List of nationally authorised medicinal products - PSUSA/00001902/201801
16/10/2018 Human medicines European public assessment report (EPAR): Praxbind, idarucizumab, Hemorrhage, 20/11/2015, Additional monitoring, 5, Authorised
16/10/2018 Veterinary medicines European public assessment report (EPAR): Cepedex, dexmedetomidine hydrochloride, 13/12/2016, 2, Authorised
16/10/2018 Periodic safety update single assessment: Hydrochlorothiazide / losartan: List of nationally authorised medicinal products - PSUSA/00001655/201802
16/10/2018 Agenda: Agenda - PDCO agenda of the 16-19 October 2018 meeting
16/10/2018 Orphan designation: Antisense oligonucleotide targeted to the SMN2 gene (nusinersen) for the: Treatment of 5q spinal muscular atrophy, 02/04/2012, Positive
15/10/2018 Minutes: Minutes - PDCO minutes of the 21-24 August 2018 meeting
15/10/2018 Press Release: Sales of antibiotics for use in food-producing animals drop across the EU
15/10/2018 Report: Sales of veterinary antimicrobial agents in 30 European countries in 2016 - Trends from 2010 to 2016 Eighth ESVAC report
15/10/2018 News and press releases: Sales of antibiotics for use in food-producing animals drop across the EU
15/10/2018 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
15/10/2018 Other: Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)
15/10/2018 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, Additional monitoring, 2, Authorised
15/10/2018 Press Release: EU authorities take further action in ongoing review of sartans
15/10/2018 Press Release: EU authorities take further action in ongoing review of sartans
15/10/2018 Other: Timetable: Non-safety referrals
15/10/2018 Other: Timetable: Safety referral (Article 107i, urgent Union procedure)
15/10/2018 News and press releases: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
15/10/2018 Veterinary medicines European public assessment report (EPAR): Broadline, eprinomectin, fipronil, praziquantel, (S)-methoprene, 04/12/2013, 6, Authorised
15/10/2018 Periodic safety update single assessment: Iloprost (iv solution): List of nationally authorised medicinal products - PSUSA/00009190/201801
15/10/2018 Periodic safety update single assessment: Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201802
15/10/2018 Veterinary medicines European public assessment report (EPAR): Equilis West Nile, inactivated chimaeric flavivirus strain YF-WN, 06/06/2013, 2, Authorised
15/10/2018 Orphan designation: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker- for the: Treatment of paroxysmal nocturnal haemoglobinuria, 14/10/2016, Positive
12/10/2018 Presentation: OMS Data Quality Standard
12/10/2018 Presentation: Presentation – UK’s withdrawal from the EU: Preparedness activities update (Marie-Helene Pinheiro)
12/10/2018 Presentation: Presentation – EudraVigilance registration updates (Oana Agheorghiesei)
12/10/2018 Presentation: Presentation – Issues and update from the CMDh (Kora Doorduyn-van der Stoep)
12/10/2018 Presentation: Presentation – Feedback on EudraVigilance & new functionalities (Anja van Haren, Sabine Brosch, F. Domergue)
12/10/2018 Human medicines European public assessment report (EPAR): NexoBrid, concentrate of proteolytic enzymes enriched in bromelain, Debridement, 18/12/2012, Orphan, Additional monitoring, 8, Authorised
12/10/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018
12/10/2018 Periodic safety update single assessment: Argatroban: List of nationally authorised medicinal products - PSUSA/00009057/201801
12/10/2018 Periodic safety update single assessment: Nafarelin: List of nationally authorised medicinal products - PSUSA/00002105/201802
12/10/2018 Periodic safety update single assessment: Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201802
12/10/2018 Periodic safety update single assessment: Tauroselcholic (75Se) acid: List of nationally authorised medicinal products - PSUSA/00010486/201801
12/10/2018 Human medicines European public assessment report (EPAR): Airexar Spiromax, salmeterol, fluticasone propionate, Pulmonary Disease, Chronic Obstructive, Asthma, 18/08/2016, 2, Authorised
12/10/2018 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 29, Authorised
12/10/2018 Orphan designation: Humanised monoclonal antibody to the folate receptor alpha for the: Treatment of ovarian cancer, 01/04/2008, Positive
12/10/2018 Orphan designation: Humanised anti-alpha ν beta 6 monoclonal antibody for the: Treatment of idiopathic pulmonary fibrosis, 29/07/2014, Positive
12/10/2018 Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for the: Treatment of beta thalassaemia intermedia and major, 29/07/2014, Positive
12/10/2018 Orphan designation: Amatuximab for the: Treatment of malignant mesothelioma, 16/01/2014, Positive
12/10/2018 Orphan designation: Macitentan for the: Treatment of pulmonary arterial hypertension, 27/09/2011, Positive
12/10/2018 Orphan designation: Macitentan for the: Treatment of idiopathic pulmonary fibrosis, 28/01/2010, Positive
12/10/2018 Orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide for the: Treatment of hepatocellular carcinoma, 23/08/2017, Positive
12/10/2018 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, Additional monitoring, 12, Authorised
12/10/2018 Orphan designation: Ciclosporin (inhalation use) for the: Treatment of bronchiolitis obliterans syndrome, 24/05/2017, Positive
12/10/2018 Orphan designation: S-acetyl-(S)-4'-phosphopantetheine, calcium salt for the: Treatment of pantothenate-kinase-associated neurodegeneration, 28/04/2016, Positive
12/10/2018 Human medicines European public assessment report (EPAR): Tolura, telmisartan, Hypertension, 04/06/2010, Generic, 8, Authorised
12/10/2018 Orphan designation: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated), 28/10/2005, Positive
12/10/2018 Orphan designation: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone for the: Treatment of cutaneous T-cell lymphoma, 27/05/2005, Positive
12/10/2018 Orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene for the: Treatment of spinal muscular atrophy, 19/06/2015, Positive
12/10/2018 Orphan designation: 2-Hydroxypropyl-β-cyclodextrin for the: Treatment of Niemann-Pick disease type C, 26/04/2013, Positive
12/10/2018 Orphan designation: Adeno-associated viral vector serotype 9 containing the human iduronate-2-sulfatase gene for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 10/08/2015, Positive
12/10/2018 Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma), clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 16/10/2009, Generic, 15, Authorised
12/10/2018 Orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene for the: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 24/01/2013, Positive
12/10/2018 Orphan designation: Adeno-associated viral vector serotype 9 containing the human sulfamidase gene for the: Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome), 21/06/2011, Positive
11/10/2018 Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, 13/11/2013, Patient safety, Additional monitoring, 10, Authorised
11/10/2018 Orphan designation: melatonin for the: Treatment of non-traumatic subarachnoid haemorrhage, 15/03/2018, Negative
11/10/2018 Orphan designation: Givinostat for the: Treatment of Becker muscular dystrophy, 31/07/2018, Positive
11/10/2018 Orphan designation: for the: Treatment of primary hyperoxaluria, 31/07/2018, Positive
11/10/2018 Orphan designation: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene for the: Treatment of congenital alpha-1 antitrypsin deficiency, 31/07/2018, Positive
11/10/2018 Orphan designation: liposomal mannose-1-phosphate for the: treatment of phosphomannomutase 2-congenital disorder of glycosylation, 31/07/2018, Positive
11/10/2018 Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 for the: treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 deficiency, 31/07/2018, Positive
11/10/2018 Orphan designation: 2ʹ-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA for the: treatment of behavioural variant frontotemporal dementia, 31/07/2018, Positive
11/10/2018 Orphan designation: Selumetinib for the: Treatment of neurofibromatosis type 1, 31/07/2018, Positive
11/10/2018 Orphan designation: Tetracosactide for the: Treatment of Duchenne muscular dystrophy, 31/07/2018, Positive
11/10/2018 Orphan designation: Combination of carboplatin and sodium valproate for the: Treatment of glioma, 31/07/2018, Positive
10/10/2018 Orphan designation: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA for the: Treatment of Duchenne muscular dystrophy, 31/07/2018, Positive
10/10/2018 Orphan designation: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast for the: Treatment of Duchenne muscular dystrophy, 31/07/2018, Positive
10/10/2018 Human medicines European public assessment report (EPAR): Raplixa, human fibrinogen, human thrombin, Hemostasis, Surgical, 19/03/2015, Additional monitoring, 6, Withdrawn
10/10/2018 Agenda: Agenda - CVMP agenda of the 9-11 October 2018
10/10/2018 Industry stakeholder meeting on Brexit and operation of centralised procedure for human and veterinary medicines , European Medicines Agency, London, UK, from 24/09/2018 to 24/09/2018
10/10/2018 Herbal - HMPC opinion on a European Union herbal monograph: Superseded opinion of the HMPC on a Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version
10/10/2018
10/10/2018 Herbal - HMPC assessment report: Superseded assessment report on Oenothera biennis L., Oenothera lamarckiana L., oleum - First version
10/10/2018 Herbal - List of references supporting the assessment report: Superseded list of references supporting the assessment of Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version
10/10/2018 Orphan designation: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded for the: Treatment of graft-versus-host disease, 31/07/2018, Positive
10/10/2018 Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid, 01/07/2013, Orphan, Additional monitoring, 19, Authorised
10/10/2018 Herbal - HMPC assessment report: Superseded assessment report on Vitex agnus-castus L., fructus - First version
10/10/2018 Herbal - List of references supporting the assessment report: Superseded list of references supporting the assessment of Vitex agnus-castus L., fructus - First version
10/10/2018 Herbal - Overview of comments received during consultation: Superseded overview of comments received on Community herbal monograph on Vitex agnus-castus L., fructus (EMA/HMPC/144006/2009) - First version
10/10/2018 Herbal – European Union herbal monograph: Superseded Community herbal monograph on Vitex agnus-castus L., fructus - First version
10/10/2018 Herbal - HMPC opinion on a European Union herbal monograph: Superseded opinion of the HMPC on a Community herbal monograph on Vitex agnus-castus L., fructus - First version
09/10/2018 Human medicines European public assessment report (EPAR): Imatinib Teva B.V., imatinib mesilate, Dermatofibrosarcoma, Gastrointestinal Stromal Tumors, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 15/11/2017, Generic, Withdrawn
09/10/2018 Press Release: Update on EMA’s Brexit preparedness
09/10/2018 News and press releases: Update on EMA’s Brexit preparedness
09/10/2018 Other: Cut-off dates for UK Rapporteurship appointments for pre and post authorisation procedures for centrally authorised products
09/10/2018 Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva, mycophenolate mofetil, Graft Rejection, 21/02/2008, Generic, 20, Authorised
09/10/2018 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 10, Authorised
09/10/2018 Other: EMA Brexit Preparedness Business Continuity Plan – Phase 3 implementation plan
09/10/2018 Agenda: Agenda - COMP agenda of the 9-11 October 2018 meeting
09/10/2018 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, Additional monitoring, 13, Authorised
09/10/2018 Newsletter: Human medicines highlights - October 2018
09/10/2018 Minutes: Minutes of the CAT written procedure 15-17 August 2018
08/10/2018 Report: A common data model for Europe - Why? Which? How? - Workshop report
08/10/2018 Human medicines European public assessment report (EPAR): Aptivus, tipranavir, HIV Infections, 25/10/2005, 36, Authorised
08/10/2018 Human medicines European public assessment report (EPAR): Stivarga, regorafenib, Colorectal Neoplasms, 26/08/2013, 14, Authorised
08/10/2018 Veterinary medicines European public assessment report (EPAR): Trifexis, spinosad, milbemycin oxime, 19/09/2013, 4, Withdrawn
08/10/2018 Human medicines European public assessment report (EPAR): Potactasol, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 06/01/2011, Generic, 7, Authorised
08/10/2018 Herbal medicinal product: Echinaceae pallidae radix, Echinaceae pallidae radix, F: Assessment finalised
08/10/2018 Human medicines European public assessment report (EPAR): Myfenax, mycophenolate mofetil, Graft Rejection, 21/02/2008, Generic, 20, Authorised
08/10/2018 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection, Bacterial Infections, 20/09/2018, Additional monitoring, Authorised
08/10/2018 Human medicines European public assessment report (EPAR): Pramipexole Teva, pramipexole dihydrochloride monohydrate, Parkinson Disease, 18/12/2008, Generic, 19, Authorised
08/10/2018 12th pharmacovigilance stakeholder forum , European Medicines Agency, London, UK, from 24/09/2018 to 24/09/2018
08/10/2018 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, Additional monitoring, 8, Authorised
08/10/2018 Periodic safety update single assessment: Iron parenteral preparations: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010236/201801
08/10/2018 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 3, Authorised
08/10/2018 Periodic safety update single assessment: Iron parenteral preparations: List of nationally authorised medicinal products - PSUSA/00010236/201801
05/10/2018 Minutes: Minutes of the CHMP meeting 23-26 July 2018
05/10/2018 Other: Referentials Management Service (RMS) and Organisations Management Services (OMS) industry on-boarding plan
05/10/2018 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 30, Authorised
05/10/2018 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018
05/10/2018 News and press releases: Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects
05/10/2018 News and press releases: EMA Management Board: highlights of October 2018 meeting
04/10/2018 Template or form: Template for letter of intent to submit an application
04/10/2018 Veterinary medicines European public assessment report (EPAR): Comfortis, spinosad, 11/02/2011, 6, Authorised
04/10/2018 Report: Report on Haemophilia Registries Workshop
04/10/2018 Agenda: Agenda for the 101st meeting of the Management Board
03/10/2018 Agenda: Agenda - CAT agenda for the written procedure of 15-17 August 2018
03/10/2018 Overview of comments: Review of comments submitted on the draft Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR)
03/10/2018 Regulatory and procedural guideline: Qualification Opinion on The European Cystic Fibrosis Society Patient Registry (ECFSPR) and CF Pharmaco-epidemiology Studies
02/10/2018 Template or form: Plasma master file timetable: 90-day – Period 2018-2021