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Date Content
20/05/2020 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
20/05/2020 COVID-19: What's new (updated)
20/05/2020 News and press releases: Global regulators commit to cooperate on observational research in the context of COVID-19
20/05/2020 Periodic safety update single assessment: Drospirenone / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00010217/201909 (new)
20/05/2020 Periodic safety update single assessment: Betamethasone / tetryzoline: List of nationally authorised medicinal products - PSUSA/00010072/201909 (new)
20/05/2020 Periodic safety update single assessment: Itopride: List of nationally authorised medicinal products - PSUSA/00010606/201906 (new)
20/05/2020 Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia, Iron Overload, 25/08/1999, 27, Authorised (updated)
20/05/2020 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010, Generic, 10, Authorised (updated)
20/05/2020 Human medicines European public assessment report (EPAR): Ongentys, opicapone, Parkinson Disease, 24/06/2016, Additional monitoring, 5, Authorised (updated)
20/05/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Ciclesonide (new)
20/05/2020 Periodic safety update single assessment: Chlorquinaldol (vaginal tablet) / promestriene : List of nationally authorised medicinal products - PSUSA/00009272/201909 (new)
20/05/2020 Periodic safety update single assessment: Aminosalicylate sodium: List of nationally authorised medicinal products - PSUSA/00000165/201910 (new)
20/05/2020 Periodic safety update single assessment: Clenbuterol: List of nationally authorised medicinal products - PSUSA/00000794/201909 (new)
20/05/2020 Periodic safety update single assessment: Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201909 (new)
20/05/2020 Periodic safety update single assessment: Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201909 (new)
20/05/2020 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,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,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leuprorelina Trimestral Sandoz,Leupro-Sandoz 3-Monats-Depot,Leuprostin,Leuproreline Sandoz,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, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 14/05/2020, 20/05/2020 (updated)
20/05/2020 Human medicines European public assessment report (EPAR): Clopidogrel Mylan, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 15, Authorised (updated)
20/05/2020 Regulatory and procedural guideline: EudraVigilance registration manual (updated)
20/05/2020 Agenda: Agenda - European Medicines Agency and EuropaBio (new)
20/05/2020 European Medicines Agency and EuropaBio , Virtual meeting, from 26/05/2020 to 26/05/2020
20/05/2020 Orphan designation: Mertansine functionalised gold nanoconjugate for the: Treatment of hepatocellular carcinoma, 22/02/2018, Withdrawn (updated)
20/05/2020 Orphan designation: romilkimab for the: Treatment of systemic sclerosis, 09/01/2020, Positive
20/05/2020 Orphan designation: Setmelanotide for the: Treatment of Alström syndrome, 09/01/2020, Positive
20/05/2020 Orphan designation: ziritaxestat for the: Treatment of systemic sclerosis, 09/01/2020, Positive
20/05/2020 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Position provided by CMDh, 25/03/2020, 20/05/2020 (updated)
20/05/2020 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 10, Authorised (updated)
20/05/2020 Pharmacovigilance (updated)
20/05/2020 Regulatory and procedural guideline: Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products during 2020 (new)
19/05/2020 2019 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) , European Medicines Agency, Amsterdam, The Netherlands, from 14/10/2019 to 14/10/2019 (updated)
19/05/2020 EMA’s governance during COVID-19 pandemic (updated)
19/05/2020 Agenda: Agenda - 2019 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) (new)
19/05/2020 Regulatory and procedural guideline: Checklist for Initial Notifications for Parallel Distribution: Guidance for industry (new)
19/05/2020 ICH E6(R3) Good Clinical Practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties , Virtual meeting, from 03/06/2020 to 03/06/2020
19/05/2020 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting , Virtual meeting, from 02/06/2020 to 02/06/2020 (updated)
19/05/2020 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)
19/05/2020 Agenda: Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting (new)
19/05/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2020 (new)
19/05/2020 Human medicines European public assessment report (EPAR): Waylivra, Volanesorsen sodium, Hyperlipoproteinemia Type I, 03/05/2019, Orphan, Additional monitoring, Conditional approval, 2, Authorised (updated)
19/05/2020 Other: Inventory of herbal substances for assessment (updated)
19/05/2020 Veterinary medicines European public assessment report (EPAR): Palladia, toceranib, 23/09/2009, 9, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Stalevo, levodopa, carbidopa, entacapone, Parkinson Disease, 17/10/2003, 26, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, Accelerated assessment, 3, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 9, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, 18/12/2018, Orphan, 2, Authorised (updated)
19/05/2020 News and press releases: Essential work to combat the COVID-19 pandemic to continue during EMA's closure from 21 to 22 May 2020
19/05/2020 Periodic safety update single assessment: Valsartan / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010735/201910 (new)
19/05/2020 Periodic safety update single assessment: Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201909 (new)
19/05/2020 Periodic safety update single assessment: Atenolol / chlortalidone: List of nationally authorised medicinal products - PSUSA/00000260/201909 (new)
19/05/2020 Human medicines European public assessment report (EPAR): Lonsurf, trifluridine, tipiracil hydrochloride, Colorectal Neoplasms, 25/04/2016, Additional monitoring, 5, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 5, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 13, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 8, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 20, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Dengvaxia, chimeric yellow fever dengue virus serotype 1 (live, attenuated) / chimeric yellow fever dengue virus serotype 2 (live, attenuated) / chimeric yellow fever dengue virus serotype 3 (live, attenuated) / chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue, 12/12/2018, Additional monitoring, 2, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 8, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, Additional monitoring, 8, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, Additional monitoring, 20, Authorised (updated)
19/05/2020 Periodic safety update single assessment: Busulfan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-0464-201907 (new)
19/05/2020 Orphan designation: motixafortide for the: Treatment of pancreatic cancer, 09/01/2020, Positive
19/05/2020 Human medicines European public assessment report (EPAR): Lymphoseek, tilmanocept, Radionuclide Imaging, 19/11/2014, 6, Authorised (updated)
19/05/2020 Periodic safety update single assessment: Busulfan: List of nationally authorised medicinal products - PSUSA-0464-201907 (new)
19/05/2020 Orphan designation: Human telomerase reverse transcriptase peptide (611-626) for the: Treatment of pancreatic cancer, 25/07/2006, Positive (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, Patient safety, 21, Authorised (updated)
19/05/2020 Orphan designation: autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene for the: Treatment of sickle cell disease, 09/01/2020, Positive
19/05/2020 Human medicines European public assessment report (EPAR): Kolbam , cholic acid, Metabolism, Inborn Errors, 20/11/2015, Orphan, Additional monitoring, Exceptional circumstances, 14, Authorised (updated)
19/05/2020 Orphan designation: adeno-associated virus serotype 2/6 encoding human alpha-galactosidase A cDNA for the: Treatment of Fabry disease, 09/01/2020, Positive
19/05/2020 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 10, Authorised (updated)
19/05/2020 Human medicines European public assessment report (EPAR): Osseor, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Withdrawn (updated)
19/05/2020 Public Statement: Public statement on Osseor: Withdrawal of the marketing authorisation in the European Union (new)
19/05/2020 Orphan designation: nicardipine for the: Treatment of non-traumatic subarachnoid haemorrhage, 09/01/2020, Positive
19/05/2020 Orphan designation: adeno-associated virus serotype 9 vector containing human n-acetylgalactosamine-6-sulfate sulfatase gene for the: Treatment of mucopolysaccharidosis type IVA (Morquio A Syndrome), 09/01/2020, Positive
19/05/2020 Orphan designation: Tripotassium citrate monohydrate and potassium hydrogen carbonate for the: Treatment of cystinuria, 09/01/2020, Positive
18/05/2020 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Additional monitoring, Exceptional circumstances, 16, Authorised (updated)
18/05/2020 Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2019 meeting (new)
18/05/2020 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 15, Authorised (updated)
18/05/2020 Procurement: Ex ante publicity of a negotiated procedure: EMA/2020/16/FI – Value Added Tax (VAT) consultancy services (new)
18/05/2020 Regulatory and procedural guideline: HMPC rules of procedure (updated)
18/05/2020 Minutes: Minutes of the CAT meeting 19-21 February 2020 (new)
18/05/2020 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 (updated)
18/05/2020 Agenda: Agenda - CVMP agenda of the 18-20 May 2020 meeting (new)
18/05/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 08/07/2020 to 10/07/2020
18/05/2020 Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
18/05/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 22/06/2020 to 24/06/2020
18/05/2020 Pre-authorisation guidance (updated)
18/05/2020 EudraVigilance training and support (updated)
18/05/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training course using the EudraVigilance System , Virtual training course, from 25/05/2020 to 29/05/2020
18/05/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training course using the EudraVigilance System , Virtual training course, from 08/06/2020 to 12/06/2020
18/05/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training course using the EudraVigilance System , Virtual training course, from 22/06/2020 to 26/06/2020
18/05/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training course using the EudraVigilance System , Virtual training course, from 06/07/2020 to 10/07/2020
18/05/2020 Agenda: Agenda - PDCO agenda of the 28-30 April 2020 meeting (new)
18/05/2020 2020 European Union Good Clinical Practice Inspectors Working Group workshop , Seeheim-Jugenheim (close to Frankfurt am Main), Germany, from 30/09/2020 to 02/10/2020 (updated)
18/05/2020 Minutes: Minutes of the HMPC 13-15 January 2020 meeting (new)
18/05/2020 Other: Expected publication dates of PRAC recommendations on safety signals (updated)
18/05/2020 Innovation in medicines (updated)
18/05/2020 Template or form: Innovation Task Force (ITF) briefing meeting request form (new)
18/05/2020 News and press releases: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
18/05/2020 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
18/05/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
18/05/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
18/05/2020 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
18/05/2020 Periodic safety update single assessment: Pramiracetam: List of nationally authorised medicinal products - PSUSA/00002492/201909 (new)
18/05/2020 Transfer of marketing authorisation: questions and answers (updated)
18/05/2020 Risk management plan (RMP): questions and answers (updated)
18/05/2020 Periodic safety update reports (PSURs) (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, 23/08/2012, 19, Authorised (updated)
18/05/2020 Post-authorisation safety studies (PASS) (updated)
18/05/2020 Post-authorisation measures: questions and answers (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Grepid, clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 27/07/2009, Generic, 20, Authorised (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Ruconest, Recombinant human C1-inhibitor, Angioedemas, Hereditary, 28/10/2010, 10, Authorised (updated)
18/05/2020 Renewal and annual re-assessment of marketing authorisation (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 13, Authorised (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia, Arthritis, Gouty, Gout, 15/06/2017, Generic, 4, Authorised (updated)
18/05/2020 Grouping of variations: questions and answers (updated)
18/05/2020 Type-II variations: questions and answers (updated)
18/05/2020 Extensions of marketing authorisations: questions and answers (updated)
18/05/2020 Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, 13/11/2013, Patient safety, Additional monitoring, 11, Authorised (updated)
18/05/2020 Type-IB variations: questions and answers (updated)
18/05/2020 Type-IA variations: questions and answers (updated)
18/05/2020 Agenda: Agenda - CAT agenda of the 18-20 May 2020 meeting (new)
18/05/2020 Agenda: Agenda - COMP agenda of the 18-20 May 2020 meeting (new)
15/05/2020 Veterinary medicines European public assessment report (EPAR): Convenia, cefovecin, 19/06/2006, 12, Authorised (updated)
15/05/2020 Human medicines European public assessment report (EPAR): Xultophy, insulin degludec, liraglutide, Diabetes Mellitus, Type 2, 18/09/2014, 14, Authorised (updated)
15/05/2020 Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 23/01/2019, Initial authorisation (updated)
15/05/2020 News and press releases: EU actions to support availability of medicines during COVID-19 pandemic – update #6
15/05/2020 Public Statement: Public statement on Protelos: Withdrawal of the marketing authorisation in the European Union (new)
15/05/2020 Human medicines European public assessment report (EPAR): Protelos, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Withdrawn (updated)
15/05/2020 Guidance for medicine developers and companies on COVID-19 (updated)
15/05/2020 News and press releases: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15/05/2020 News and press releases: Update of EU recommendations for 2020/2021 seasonal flu vaccine composition
15/05/2020 Scientific publications (updated)
15/05/2020 Regulatory and procedural guideline: Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021 (updated)
15/05/2020 Minutes: Minutes of the COMP meeting 17-19 March 2020 (new)
15/05/2020 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, Additional monitoring, 8, Authorised (updated)
15/05/2020 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 16, Authorised (updated)
15/05/2020 Orphan designation: Itraconazole for the: Prevention of invasive aspergillosis, 25/05/2018, Positive (updated)
15/05/2020 Maximum Residue Limits - Report: Ciclesonide (equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP (new)
15/05/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020
15/05/2020 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, 31, Authorised (updated)
15/05/2020 News and press releases: Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
15/05/2020 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 25, Authorised (updated)
15/05/2020 Orphan designation: 2-(3,7-Dimethyl-octa-2, 6-dienyl)-6-ethylamino-3-hydroxy-5-pentyl-[1,4]benzoquinone for the: Treatment of Huntington's disease, 09/01/2020, Positive
15/05/2020 Fees payable to the European Medicines Agency (updated)
14/05/2020 Recruitment: Decision of the Executive Director on rules governing the traineeship programme at the EMA (updated)
14/05/2020 Recruitment: Traineeship - Frequently asked questions (FAQs) (new)
14/05/2020 Other: Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) (updated)
14/05/2020 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 39, Authorised (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 17, Authorised (updated)
14/05/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2020 (new)
14/05/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Bambermycin (new)
14/05/2020 Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Schizophrenia, Bipolar Disorder, 20/08/2015, Generic, 7, Authorised (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 16, Authorised (updated)
14/05/2020 Maximum Residue Limits - Report: Bambermycin (rabbit): European public maximum-residue-limit assessment report (EPMAR) - CVMP (new)
14/05/2020 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 46, Authorised (updated)
14/05/2020 Other: Extension of reserve lists for external selection procedures: Temporary Agent reserve lists (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane sulfate, tazobactam sodium, Bacterial Infections, 18/09/2015, 11, Authorised (updated)
14/05/2020 Orphan designation: dimethyl fumarate for the: Treatment of adrenoleukodystrophy, 09/01/2020, Positive
14/05/2020 Other: Decision of the Executive Director on fee reductions for Good Manufacturing Practice (GMP) on-site inspections due to COVID-19 pandemic (new)
14/05/2020 Annual Report: Annual report of the Good Clinical Practice Inspectors' Working Group 2018 (new)
14/05/2020 Good manufacturing practice (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Forsteo, teriparatide, Osteoporosis, Osteoporosis, Postmenopausal, 10/06/2003, 21, Authorised (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 25, Authorised (updated)
14/05/2020 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 20, Authorised (updated)
14/05/2020 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, 25, Authorised (updated)
13/05/2020 Veterinary medicines European public assessment report (EPAR): Stelfonta, tigilanol tiglate, 15/01/2020, 1, Authorised (updated)
13/05/2020 Other: Record of data processing activity relating to trainings (public) (updated)
13/05/2020 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Additional monitoring, Biosimilar, 3, Authorised (updated)
13/05/2020 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 37, Authorised (updated)
13/05/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2020 (new)
13/05/2020 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency, Amsterdam, the Netherlands, from 21/02/2020 to 21/02/2020
13/05/2020 Minutes: Minutes of the Enpr-EMA Coordinating Group & networks meeting on 21 February 2020 (new)
13/05/2020 Agenda: Agenda - Enpr-EMA Coordinating Group & networks meeting on 21 February 2020 (new)
13/05/2020 Orphan designation: pasireotide for the: Treatment of acromegaly, 08/10/2009, Positive (updated)
13/05/2020 Orphan designation: pasireotide for the: Treatment of Cushing's disease, 08/10/2009, Positive (updated)
13/05/2020 Minutes: Minutes of the CAT meeting 18-20 March 2020 (new)
13/05/2020 Referral: Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs , Tylosin , Article 35, European Commission final decision, 05/12/2019, 17/04/2020
12/05/2020 Other: Article 57 product data (updated)
12/05/2020 Work programme: Work Plan 2020 of the Good Clinical Practice Inspectors' Working Group (new)
12/05/2020 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Skin Diseases, Bacterial, 16/12/2019, Additional monitoring, 1, Authorised (updated)
12/05/2020 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 21/03/2014, 19, Authorised (updated)
12/05/2020 Human medicines European public assessment report (EPAR): Palonosetron Accord, Palonosetron, Vomiting, Nausea, Cancer, 26/05/2016, Generic, 3, Authorised (updated)
12/05/2020 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 10, Authorised (updated)
12/05/2020 Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine, Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 (updated)
12/05/2020 Veterinary medicines European public assessment report (EPAR): Acticam, meloxicam, 09/12/2008, Generic, 8, Authorised (updated)
12/05/2020 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 31, Authorised (updated)
12/05/2020 Plasma master file certificates (updated)
12/05/2020 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 3, Authorised (updated)
11/05/2020 Treatments and vaccines for COVID-19 (updated)
11/05/2020 Compassionate use (updated)
11/05/2020 News and press releases: EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
11/05/2020 Report: Applications for new human medicines under evaluation by the CHMP: May 2020 (new)
11/05/2020 Newsletter: Human medicines highlights - May 2020 (new)
11/05/2020 Newsletter: Public bulletin: Veterinary pharmacovigilance 2019 (new)
11/05/2020 Newsletter: Public bulletin: Veterinary pharmacovigilance 2019 (new)
11/05/2020 Human medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Genetic Diseases, Inborn, Lung Diseases, 20/08/2015, Additional monitoring, 7, Authorised (updated)
11/05/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
11/05/2020 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 13, Authorised (updated)
11/05/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC meeting (new)
11/05/2020 Periodic safety update single assessment: Oxcarbazepinexcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/201908 (new)
11/05/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC (new)
11/05/2020 Agenda: Agenda - PRAC draft agenda of meeting 11-14 May 2020 (new)
11/05/2020 Big data (updated)
11/05/2020 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 38, Authorised (updated)
08/05/2020 Periodic safety update single assessment: Brivudine: List of nationally authorised medicinal products - PSUSA/00000434/201907 (new)
08/05/2020 Periodic safety update single assessment: Brivudine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000434/201907 (new)
08/05/2020 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 2, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 6, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 12, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): MicardisPlus, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 28, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Orphan, Accelerated assessment, 13, Authorised (updated)
08/05/2020 Periodic safety update single assessment: Ropinirole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002661201907 (new)
08/05/2020 Periodic safety update single assessment: Ropinirole: List of nationally authorised medicinal products - PSUSA/00002661201907 (new)
08/05/2020 News and press releases: EU actions to support availability of medicines during COVID-19 pandemic – update #5
08/05/2020 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 35, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 2, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration, Macular Edema, Diabetes Complications, 21/11/2012, 18, Authorised (updated)
08/05/2020 Human medicines European public assessment report (EPAR): Stayveer, bosentan monohydrate, Hypertension, Pulmonary, Scleroderma, Systemic, 24/06/2013, 12, Authorised (updated)
08/05/2020 Report: List of products granted eligibility to PRIME (updated)
08/05/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 28-30 April 2020 (new)
07/05/2020 Human medicines European public assessment report (EPAR): Temomedac, temozolomide, Glioma, Glioblastoma, 25/01/2010, Generic, 13, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Qtern, Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 15/07/2016, 6, Authorised (updated)
07/05/2020 Newsletter: News bulletin for small and medium-sized enterprises - Issue 49 (new)
07/05/2020 Minutes: CHMP ORGAM minutes for the meeting on 17 February 2020 (new)
07/05/2020 Agenda: CHMP ORGAM agenda for the meeting on 17 February 2020 (new)
07/05/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
07/05/2020 Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile for the: Treatment of acute myeloid leukaemia, 29/05/2019, Positive (updated)
07/05/2020 Orphan designation: liposomal mannose-1-phosphate for the: treatment of phosphomannomutase 2-congenital disorder of glycosylation, 31/07/2018, Positive (updated)
07/05/2020 Orphan designation: Sirolimus for the: Treatment of pachyonychia congenita, 17/07/2017, Positive (updated)
07/05/2020 Orphan designation: Rusalatide acetate for the: Treatment of acute radiation syndrome, 22/02/2018, Positive (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, 24/11/2011, Generic, 14, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): PritorPlus, telmisartan, hydrochlorothiazide, Hypertension, 22/04/2002, 34, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Hyperkalemia, 22/03/2018, Additional monitoring, 4, Authorised (updated)
07/05/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Lisbon , Lisbon, Portugal, from 11/05/2020 to 13/05/2020 (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Venclyxto, Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, 04/12/2016, Additional monitoring, 10, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, 16, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Lumark, lutetium (177 Lu) chloride, Radionuclide Imaging, 18/06/2015, Additional monitoring, 8, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Zavesca, miglustat, Gaucher Disease, Niemann-Pick Diseases, 20/11/2002, 16/06/2009, 31, Authorised (updated)
07/05/2020 Human medicines European public assessment report (EPAR): Xenical, orlistat, Obesity, 29/07/1998, 24, Authorised (updated)
07/05/2020 Environmental risk assessment for parasiticide veterinary medicinal products used in companion animals
07/05/2020 Scientific guideline: Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals (new)
07/05/2020 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 15, Authorised (updated)
07/05/2020 Orphan designation: Entolimod for the: Treatment of acute radiation syndrome, 11/01/2016, Withdrawn (updated)
07/05/2020 Veterinary medicines European public assessment report (EPAR): Canigen L4, Inactivated Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain As-05-073); L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005), 03/07/2015, 4, Authorised (updated)
07/05/2020 Veterinary medicines European public assessment report (EPAR): Innovax-ILT, Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus, 03/07/2015, 2, Authorised (updated)
06/05/2020 Medical devices (updated)
06/05/2020 Veterinary medicines European public assessment report (EPAR): NexGard, afoxolaner, 11/02/2014, 11, Authorised (updated)
06/05/2020 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Orphan, Accelerated assessment, Additional monitoring, Conditional approval, 2, Authorised (updated)
06/05/2020 Human medicines European public assessment report (EPAR): Isturisa, Osilodrostat phosphate, Cushing Syndrome, 09/01/2020, Orphan, Additional monitoring, 1, Authorised (updated)
06/05/2020 Orphan designation: Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor for B-cell maturation antigen for the: Treatment of multiple myeloma, 28/02/2020, Positive
06/05/2020 Orphan designation: Combination of three adeno-associated viral vectors of serotype 8 containing the 5'-, the body- and the 3'- coding sequences of human CEP290 fused to inteins for the: Treatment of inherited retinal dystrophies, 28/02/2020, Positive
06/05/2020 Orphan designation: Autologous skin equivalent graft composed of keratinocytes and fibroblasts genetically corrected by CRISPR/Cas9-mediated excision of mutation-carrying COL7A1 exon 80 for the: Treatment of epidermolysis bullosa, 28/02/2020, Positive