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19/03/2020 Other: Revised rules of procedure of the Management Board (updated)
19/03/2020 Periodic safety update single assessment: Amsacrine: List of nationally authorised medicinal products - PSUSA/00000199/201906 (new)
19/03/2020 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, 7, Authorised (updated)
19/03/2020 From data to evidence in medicines regulation , European Medicines Agency, Amsterdam, The Netherlands, from 07/09/2020 to 07/09/2020 (updated)
19/03/2020 Human medicines European public assessment report (EPAR): Skyrizi, Risankizumab, Psoriasis, 26/04/2019, Additional monitoring, 2, Authorised (updated)
19/03/2020 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 38, Authorised (updated)
19/03/2020 Regulatory and procedural guideline: Notice to stakeholders - Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products (new)
19/03/2020 Regulatory and procedural guideline: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure (updated)
19/03/2020 Brexit-related guidance for companies (updated)
19/03/2020 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 6, Authorised (updated)
19/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, Generic, 13, Authorised (updated)
19/03/2020 Other: Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19 (new)
19/03/2020 Minutes: Minutes - PDCO minutes of the 15-18 October 2019 meeting (new)
19/03/2020 Human medicines European public assessment report (EPAR): Deferiprone Lipomed, Deferiprone, Iron Overload, beta-Thalassemia, 19/09/2018, Generic, 2, Authorised (updated)
19/03/2020 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201905 (new)
19/03/2020 Periodic safety update single assessment: Allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010475/201907 (new)
19/03/2020 News and press releases: Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
19/03/2020 Agenda: Agenda for the 107th meeting of the Management Board (new)
19/03/2020 Agenda: Agenda - CAT agenda of the 18-20 March 2020 meeting (new)
18/03/2020 News and press releases: First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
18/03/2020 Template or form: Template letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party (updated)
18/03/2020 Human medicines European public assessment report (EPAR): Spinraza, nusinersen sodium, Muscular Atrophy, Spinal, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised (updated)
18/03/2020 Template or form: Template letter of intent for request of scientific advice or protocol assistance (updated)
18/03/2020 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 27, Authorised (updated)
18/03/2020 Periodic safety update single assessment: Human coagulation factor viii / human von willebrand factor : List of nationally authorised medicinal products - PSUSA/00001621/201810 (new)
18/03/2020 Periodic safety update single assessment: Bromocriptine : List of nationally authorised medicinal products - PSUSA/00000438/201810 (new)
18/03/2020 Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Diabetes Mellitus, 30/04/1996, 31, Authorised (updated)
18/03/2020 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
18/03/2020 Periodic safety update single assessment: Nimodipine: List of nationally authorised medicinal products - PSUSA/00002166/201811 (new)
18/03/2020 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 11, Authorised (updated)
18/03/2020 Periodic safety update single assessment: Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201906 (new)
18/03/2020 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 6, Authorised (updated)
18/03/2020 News and press releases: EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
18/03/2020 Human medicines European public assessment report (EPAR): Edarbi, Azilsartan medoxomil, Hypertension, 07/12/2011, 8, Authorised (updated)
18/03/2020 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 26, Authorised (updated)
18/03/2020 Other: Article 57 product data (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, Additional monitoring, 14, Authorised (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge, Urinary Bladder, Overactive, 22/10/2004, 22, Authorised (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Hulio, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 16/09/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
17/03/2020 Periodic safety update single assessment: Human coagulation factor IX: List of nationally authorised medicinal products - PSUSA/00001617/201907 (new)
17/03/2020 Agenda: Agenda - CVMP agenda of the 17-18 March 2020 meeting (new)
17/03/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 17-18 March 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 17/03/2020 to 18/03/2020 (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, Patient safety, 19, Authorised (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Aptivus, tipranavir, HIV Infections, 25/10/2005, 37, Authorised (updated)
17/03/2020 Periodic safety update single assessment: Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905 (new)
17/03/2020 Periodic safety update single assessment: Methadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/201905 (new)
17/03/2020 Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Diabetes Mellitus, 09/09/2014, Biosimilar, 8, Authorised (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel hydrogen sulphate, Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 14, Authorised (updated)
17/03/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 4, Authorised (updated)
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Madrid , Madrid, Spain, from 25/03/2020 to 27/03/2020 (updated)
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Bucharest , Bucharest, Romania, from 01/04/2020 to 03/04/2020 (updated)
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Prague , Prague, Czechia, from 22/04/2020 to 24/04/2020 (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 24, Authorised (updated)
16/03/2020 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Enantone-Gyn Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leupro-Sandoz 3-Monats-Depot,Leuprostin,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, Under evaluation, 16/03/2020 (updated)
16/03/2020 Other: EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list (updated)
16/03/2020 Other: Important medical event terms list version (MedDRA version 23.0) (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 34, Authorised (updated)
16/03/2020 Paediatric Committee (PDCO) (updated)
16/03/2020 Work programme: PDCO work plan 2020 (new)
16/03/2020 Report: European Medicines Agency budget for 2020 (updated)
16/03/2020 Procurement: Ex ante publicity of a negotiated procedure: EMA/2020/07/SG - Coaching and management development workshops (new)
16/03/2020 Procurement (updated)
16/03/2020 Report: Applications for new human medicines under evaluation by the CHMP: March 2020 (new)
16/03/2020 Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/11/2019, Generic, Authorised (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, 8, Authorised (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Graft Rejection, 23/04/2007, 20, Authorised (updated)
16/03/2020 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 6, Authorised (updated)
13/03/2020 Template or form: Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product (updated)
13/03/2020 News and press releases: COVID-19: developers of medicines or vaccines to benefit from free scientific advice
13/03/2020 Other: CAT work plan 2020 (new)
13/03/2020 News and press releases: Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk
13/03/2020 Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products , capecitabine, fluorouracil, tegafur, flucytosine , Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 13/03/2020 (updated)
13/03/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
13/03/2020 Referral: Ifosfamide solutions , ifosfamide , Ifosfamide Eg,Ifo-Cell,Ifo-Cell N,Ifo-Cell N 2000, Article 31 referrals, Procedure started
13/03/2020 Template or form: Appendix V - Adverse-drug-reaction reporting details (updated)
13/03/2020 Other: European Medicines Agency’s privacy statement for the Information Centre (new)
13/03/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2020 (new)
13/03/2020 Clinical pharmacology and pharmacokinetics: questions and answers (updated)
13/03/2020 Other: Records of data processing activity for managing the loaning of Information Centre material (public) (new)
13/03/2020 Scientific publications (updated)
12/03/2020 Periodic safety update single assessment: Zaleplon: List of nationally authorised medicinal products - PSUSA/00003140/201907 (new)
12/03/2020 Periodic safety update single assessment: Levomethadone: List of nationally authorised medicinal products - PSUSA/00001855/201905 (new)
12/03/2020 Periodic safety update single assessment: Levomethadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/201905 (new)
12/03/2020 Human medicines European public assessment report (EPAR): Zyprexa, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/1996, 40, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Epilepsy, 07/01/2014, Generic, 14, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 14/07/1998, 42, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 11, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): Zyprexa Velotab, olanzapine, Schizophrenia, Bipolar Disorder, 03/02/2000, 29, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 21/03/2017, Additional monitoring, Biosimilar, 8, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 22, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): M-M-RVaxPro, measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella, Mumps, Immunization, Measles, 05/05/2006, 24, Authorised (updated)
12/03/2020 Human medicines European public assessment report (EPAR): Prialt, ziconotide, Injections, Spinal, Pain, 21/02/2005, 24, Authorised (updated)
11/03/2020 Veterinary medicines European public assessment report (EPAR): Zulvac SBV, Inactivated Schmallenberg virus, strain BH80/11-4, 06/02/2015, 3, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel hydrochloride, 20/09/2009, Generic, 11, Authorised (updated)
11/03/2020 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, 54, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular, Pain, Postoperative, 28/07/2015, 5, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren), clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 17, Authorised (updated)
11/03/2020 News and press releases: COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020
11/03/2020 Newsletter: Human medicines highlights - March 2020 (new)
11/03/2020 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 10, Authorised (updated)
11/03/2020 Work programme: PRAC work plan 2020 (new)
11/03/2020 Human medicines European public assessment report (EPAR): Esperoct, Turoctocog alfa pegol, Hemophilia A, 20/06/2019, Additional monitoring, 1, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): IntronA, interferon alfa-2b, Carcinoid Tumor, Leukemia, Hairy Cell, Lymphoma, Follicular, Hepatitis B, Chronic, Hepatitis C, Chronic, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Melanoma, Multiple Myeloma, 09/03/2000, 33, Authorised (updated)
11/03/2020 Referral: Ranitidine-containing medicinal products , ranitidine , Article 31 referrals, Under evaluation, 19/09/2019, 11/03/2020 (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 14, Authorised (updated)
11/03/2020 Implementation of the new Veterinary Medicines Regulation (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 12, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 23, Authorised (updated)
11/03/2020 Agenda: Agenda - PRAC draft agenda of meeting 9-12 March 2020 (new)
11/03/2020 Human medicines European public assessment report (EPAR): Increlex, Mecasermin, Laron Syndrome, 02/08/2007, Additional monitoring, Exceptional circumstances, 21, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, 35, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Zalviso, sufentanil, Pain, Postoperative, 18/09/2015, 5, Authorised (updated)
11/03/2020 Veterinary medicines European public assessment report (EPAR): Respiporc Flu3, inactivated influenza-A virus / swine, 14/01/2010, 3, Authorised (updated)
11/03/2020 Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Prostatic Neoplasms, 21/06/2013, 26/04/2013, 15, Authorised (updated)
11/03/2020 Periodic safety update single assessment: Tolperisone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002991/201906 (new)
11/03/2020 Periodic safety update single assessment: Tolperisone: List of nationally authorised medicinal products - PSUSA/00002991/201906 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Silapo, epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic, 18/12/2007, Biosimilar, 15, Authorised (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 15, Authorised (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 47, Authorised (updated)
10/03/2020 Periodic safety update single assessment: Moxifloxacin (systemic use): CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009231/201905 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Zyllt, clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction, 28/09/2009, Generic, 13, Authorised (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, Additional monitoring, Conditional approval, 17, Authorised (updated)
10/03/2020 Periodic safety update single assessment: Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201905 (new)
10/03/2020 Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Cholestagel, colesevelam, Hypercholesterolemia, 09/03/2004, 21, Authorised (updated)
10/03/2020 Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 43, Authorised (updated)
10/03/2020 Other: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive - 2019 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Yargesa, miglustat, Gaucher Disease, 22/03/2017, Generic, 3, Authorised (updated)
10/03/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 10-13 February 2020 PRAC meeting (new)
10/03/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
10/03/2020 Minutes: Minutes of the CAT meeting 22-24 January 2020 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 7, Authorised (updated)
10/03/2020 Third European Medicines Agency-Medicines for Europe bilateral meeting , European Medicines Agency, Amsterdam, the Netherlands, from 23/03/2020 to 23/03/2020
10/03/2020 Minutes: Minutes of the CAT meeting 4-6 December 2019 (new)
10/03/2020 Committee for Advanced Therapies (CAT): 6-8 November 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 06/11/2019 to 08/11/2019 (updated)
10/03/2020 Minutes: Minutes of the CAT meeting 06-08 November 2019 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 2, Authorised (updated)
10/03/2020 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 22, Authorised (updated)
10/03/2020 News and press releases: Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU
10/03/2020 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, Additional monitoring, 10, Authorised (updated)
10/03/2020 Periodic safety update single assessment: Levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001856/201905 (new)
10/03/2020 Periodic safety update single assessment: Levonorgestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001856/201905 (new)
10/03/2020 Human medicines European public assessment report (EPAR): Truberzi, eluxadoline, Irritable Bowel Syndrome, Diarrhea, 19/09/2016, Additional monitoring, 6, Authorised (updated)
10/03/2020 EPAR - All authorised presentations: Silapo : EPAR - All Authorised presentations (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 8, Authorised (updated)
09/03/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: January 2020 (new)
09/03/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: February 2020 (new)
09/03/2020 Regulatory and procedural guideline: Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA) (updated)
09/03/2020 Work programme: COMP work plan 2020 (new)
09/03/2020 Human medicines European public assessment report (EPAR): Mozobil, Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma, 30/07/2009, Orphan, 18, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Abraxane, paclitaxel, Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, 11/01/2008, 26, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 14, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 28, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Givlaari, Givosiran, Porphyrias, Hepatic, 02/03/2020, Orphan, Additional monitoring, Authorised
09/03/2020 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA, covalently linked to a ligand containing three N-acetylgalactosamine residues (givosiran) for the: Treatment of acute hepatic porphyria, 29/08/2016, Positive (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Zepatier, elbasvir, grazoprevir, Hepatitis C, Chronic, 22/07/2016, Additional monitoring, 8, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Emgality, Galcanezumab, Migraine Disorders, 14/11/2018, Additional monitoring, 3, Authorised (updated)
09/03/2020 Human medicines European public assessment report (EPAR): Zevalin, ibritumomab tiuxetan, Lymphoma, Follicular, 16/01/2004, 22, Authorised (updated)
06/03/2020 Veterinary medicines European public assessment report (EPAR): Letifend, recombinant protein Q from Leishmania infantum MON-1, 20/04/2016, 6, Authorised (updated)
06/03/2020 Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2020 , from 09/03/2020 to 12/03/2020 (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 10, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib citrate, Arthritis, Rheumatoid, 21/03/2017, 25/04/2013, Patient safety, Additional monitoring, 9, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir sulfate, HIV Infections, 22/08/2016, Generic, 7, Authorised (updated)
06/03/2020 Referral: Xeljanz , tofacitinib , Article 20 procedures, European Commission final decision, 14/11/2019, 31/01/2020, 06/03/2020 (updated)
06/03/2020 Withdrawn application: Ekesivy, diclofenamide, Date of withdrawal: 02/10/2019, Initial authorisation (updated)
06/03/2020 News and press releases: Regulatory information – adjusted fees for applications to EMA from 1 April 2020 (updated)
06/03/2020 Orphan designation: Yttrium (90Y)-DOTA-radiolabelled humanized monoclonal antibody against mucin 1 for the: Treatment of pancreatic cancer, 06/02/2009, Withdrawn (updated)
06/03/2020 Orphan designation: Veltuzumab for the: Treatment of chronic lymphocytic leukaemia, 29/01/2010, Withdrawn (updated)
06/03/2020 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint meeting , European Medicines Agency, Amsterdam, the Netherlands, from 03/03/2020 to 04/03/2020 (updated)
06/03/2020 Agenda: Agenda - PCWP/HCPWP joint meeting on 3-4 March 2020 (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Ivabradine Zentiva, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 11/11/2016, Generic, 2, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin hydrochloride / cytarabine, Leukemia, Myeloid, Acute, 23/08/2018, Orphan, 3, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 4, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Crysvita, Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant, 19/02/2018, Orphan, Additional monitoring, Conditional approval, 5, Authorised (updated)
06/03/2020 Third international awareness session on science and regulation for animal health and welfare, public health and the environment , European Medicines Agency, Amsterdam, the Netherlands, from 02/04/2020 to 03/04/2020 (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 42, Authorised (updated)
06/03/2020 Human medicines European public assessment report (EPAR): Sirturo, bedaquiline fumarate, Tuberculosis, Multidrug-Resistant, 05/03/2014, Orphan, Additional monitoring, Conditional approval, 17, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Rinvoq, Upadacitinib, Arthritis, Rheumatoid, 16/12/2019, Additional monitoring, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Caspofungin Accord, caspofungin acetate, Candidiasis, Aspergillosis, 11/02/2016, Generic, 6, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Praxbind, idarucizumab, Hemorrhage, 20/11/2015, Accelerated assessment, Additional monitoring, 6, Authorised (updated)
05/03/2020 Joint European Medicines Agency (EMA) / European Organisation for Research and Treatment of Cancer (EORTC) workshop on novel patient-reported outcomes (PRO) and quality of life (QoL) approaches in cancer clinical research , European Medicines Agency, Amsterdam, the Netherlands, from 12/03/2020 to 13/03/2020 (updated)
05/03/2020 Management Board meeting: 18-19 December 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 18/12/2019 to 19/12/2019 (updated)
05/03/2020 Minutes: Minutes of the 106th meeting of the Management Board: 18-19 December 2019 (new)
05/03/2020 Minutes: Minutes of the CVMP meeting of 21-23 January 2020 (new)
05/03/2020 Referral: Panexcell , Article 31 referrals, Procedure started, 27/02/2020, 05/03/2020 (updated)
05/03/2020 Report: List of products granted eligibility to PRIME (updated)
05/03/2020 Veterinary medicines European public assessment report (EPAR): Nasym, live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56, 29/07/2019, 1, Authorised (updated)
05/03/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 February 2020 (new)
05/03/2020 Veterinary medicines European public assessment report (EPAR): Cerenia, maropitant citrate, 28/09/2006, 20, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 1, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Cholib, fenofibrate, simvastatin, Dyslipidemias, 26/08/2013, 10, Authorised (updated)
05/03/2020 Orphan designation: Triheptanoin for the: Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive (updated)
05/03/2020 Orphan designation: Triheptanoin for the: Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive (updated)
05/03/2020 Orphan designation: Triheptanoin for the: Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive (updated)
05/03/2020 Orphan designation: Triheptanoin for the: Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 17, Authorised (updated)
05/03/2020 Orphan designation: Adeno-associated viral vector serotype 8 containing the human factor-VII gene for the: Treatment of congenital factor VII deficiency, 15/01/2015, Positive (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Zostavax, varicella-zoster virus (live, attenuated), Herpes Zoster, Immunization, 19/05/2006, 28, Authorised (updated)
05/03/2020 Human medicines European public assessment report (EPAR): Byetta, exenatide, Diabetes Mellitus, Type 2, 20/11/2006, 23, Authorised (updated)
04/03/2020 Referrals document: Picato Article-20 referral - Assessment report on provisional measures (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, Patient safety, Additional monitoring, 9, Withdrawn (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Kuvan, Sapropterin dihydrochloride, Phenylketonurias, 02/12/2008, Orphan, 20, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Ovarian Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 12/11/1996, 30, Authorised (updated)
04/03/2020 Other: Involvement of patient representatives in scientific advice procedures at the European Medicines Agency (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 26, Authorised (updated)
04/03/2020 Other: Orientation guide for patient representatives and healthcare professionals - EMA building (new)
04/03/2020 Human medicines European public assessment report (EPAR): Mavenclad, Cladribine, Multiple Sclerosis, 22/08/2017, 3, Authorised (updated)
04/03/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
04/03/2020 News and press releases: Emiel van Galen elected as chair of the Committee for Herbal Medicinal Products
04/03/2020 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Additional monitoring, Biosimilar, 13, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Deferasirox Accord, deferasirox, Iron Overload, beta-Thalassemia, 09/01/2020, Generic, Authorised
04/03/2020 Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Hepatolenticular Degeneration, 25/07/2019, 2, Authorised (updated)
04/03/2020 Orphan designation: 3,4-diaminopyridine phosphate (amifampridine) for the: Treatment of Lambert-Eaton myasthenic syndrome, 19/12/2002, Withdrawn (updated)
04/03/2020 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, 18, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, 20/11/2018, 3, Authorised (updated)
04/03/2020 Veterinary medicines European public assessment report (EPAR): Clomicalm, clomipramine, 01/04/1998, 16, Authorised (updated)
04/03/2020 Aluvia H-W-764 (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 13, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 38, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 02/09/1999, 35, Authorised (updated)
04/03/2020 Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, Additional monitoring, 5, Authorised (updated)
04/03/2020 Veterinary medicines European public assessment report (EPAR): Emdocam, meloxicam, 18/08/2011, Generic, 7, Authorised (updated)
04/03/2020 Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note (updated)
04/03/2020 Other: Orphan medicines figures 2000-2019 (updated)
04/03/2020 Scientific guideline: ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 5 (new)
04/03/2020 Other: Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management) (new)
04/03/2020 Scientific guideline: ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 5 - Annexes (new)
04/03/2020 ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management (updated)
03/03/2020 Veterinary medicines European public assessment report (EPAR): Nexgard Spectra, afoxolaner, milbemycin oxime, 15/01/2015, 7, Authorised (updated)
03/03/2020 Veterinary medicines European public assessment report (EPAR): NexGard, afoxolaner, 11/02/2014, 10, Authorised (updated)
03/03/2020 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 29, Authorised (updated)
03/03/2020 News and press releases: Update on nitrosamines in EU medicines
03/03/2020 Minutes: Minutes of the CHMP meeting 9-12 December 2019 (new)
02/03/2020 Human medicines European public assessment report (EPAR): Xiapex, collagenase Clostridium histolyticum, Dupuytren Contracture, 28/02/2011, 20, Withdrawn (updated)
02/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, 26/08/2011, Generic, 10, Authorised (updated)
02/03/2020 Multi-stakeholder workshop to support implementation of the Medical Devices Regulation on drug-device combinations , European Medicines Agency, Amsterdam, the Netherlands, from 31/03/2020 to 31/03/2020
02/03/2020 Human medicines European public assessment report (EPAR): Varuby, rolapitant, Vomiting, Nausea, Cancer, 19/04/2017, Additional monitoring, 3, Withdrawn (updated)
02/03/2020 Orphan designation: dimethyl fumarate for the: Treatment of bullous pemphigoid, 14/07/2016, Positive (updated)
02/03/2020 Committee for Herbal Medicinal Products (HMPC): 2-4 March 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 02/03/2020 to 04/03/2020 (updated)
02/03/2020 Orphan designation: Human platelet antigen-1a immunoglobulin for the: Prevention of fetal and neonatal alloimmune thrombocytopenia, 27/10/2011, Positive (updated)
02/03/2020 Agenda: Agenda - HMPC agenda of the 2-4 March 2020 meeting (new)
02/03/2020 Annual Report: Annual report on the use of the special contribution for orphan medicinal products - 2019 (new)
02/03/2020 Standard Operating Procedure - SOP: Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
02/03/2020 Qualification of novel methodologies for medicine development (updated)
02/03/2020 Human medicines European public assessment report (EPAR): Mimpara, cinacalcet hydrochloride, Hypercalcemia, Parathyroid Neoplasms, Hyperparathyroidism, 22/10/2004, 22, Authorised (updated)
02/03/2020 News and press releases: EMA organisational changes come into effect
02/03/2020 Other: Organisation chart: Stakeholders and Communication (updated)
02/03/2020 Other: Organisation chart: Advisory functions (updated)