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29/05/2020 Maximum residue limits (MRL)
29/05/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 April 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 21/04/2020 to 23/04/2020
29/05/2020 Minutes: Minutes of the CVMP meeting of 21-23 April 2020
29/05/2020 Report: Bovine casein hydrolysate : Summary of assessment undertaken to determine whether the substance may be entered into the list of biological substances considered as not requiring an MRL evaluation
29/05/2020 Report: Biological substances considered as not requiring an MRL evaluation as per Regulation (EU) No. 2018/782, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
29/05/2020 Management Board meeting: 19 March 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2020 to 19/03/2020
29/05/2020 Minutes: Minutes of the 107th meeting of the Management Board: 19 March 2020
29/05/2020 Human medicines European public assessment report (EPAR): Fluad Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/(H1N1)-like virus antigen / A/(H3N2)-like virus antigen / B (victoria lineage)-like virus antigen B (yamagata lineage)-like virus antigen, Influenza, Human, 20/05/2020, Additional monitoring, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Dasselta, desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Urticaria, 28/11/2011, Generic, 11, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Mvasi, bevacizumab, Carcinoma, Renal Cell, Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms, 15/01/2018, Additional monitoring, Biosimilar, 7, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Fabry Disease, 03/08/2001, 28, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 19, Authorised
29/05/2020 Public-health advice during COVID-19 pandemic
29/05/2020 News and press releases: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
29/05/2020 Other: European Medicines Agency response to IQWIG on transparency of COVID-19 related activities
29/05/2020 Open letters
29/05/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
29/05/2020 Summary of opinion: Rozlytrek, entrectinib, 28/05/2020, Positive
29/05/2020 Withdrawn application: Erlotinib Accord, erlotinib, Date of withdrawal: 28/05/2020, Initial authorisation
29/05/2020 News and press releases: New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
29/05/2020 Summary of opinion: Hepcludex, bulevirtide, 28/05/2020, Positive
29/05/2020 Herbal - Herbal monograph: Draft European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium
29/05/2020 Herbal - Herbal monograph: Draft European Union herbal monograph on Species sedativae
29/05/2020 Human medicines European public assessment report (EPAR): INOmax, Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency, 01/08/2001, 21, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 2, Authorised
29/05/2020 Human medicines European public assessment report (EPAR): Dexdor, dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 13, Authorised
28/05/2020 News and press releases: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
28/05/2020 News and press releases: Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020
28/05/2020 Herbal - List of references supporting the assessment report: Draft list of references supporting the assessment of Species amarae
28/05/2020 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Species amarae
28/05/2020 Herbal - HMPC assessment report: Draft assessment report on Species amarae
28/05/2020 Minutes: Minutes of the CHMP meeting 24-27 February 2020
28/05/2020 Human medicines European public assessment report (EPAR): Baraclude, Entecavir, Hepatitis B, Chronic, 26/06/2006, 26, Authorised
28/05/2020 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 20, Authorised
28/05/2020 Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised
28/05/2020 Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, Additional monitoring, 1, Authorised
28/05/2020 EMA’s governance during COVID-19 pandemic
28/05/2020 News and press releases: European medicines regulatory network fully mobilised in fight against COVID-19
28/05/2020 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 39, Authorised
28/05/2020 Human medicines European public assessment report (EPAR): HyQvia, Human normal immunoglobulin, Immunologic Deficiency Syndromes, 16/05/2013, Additional monitoring, 14, Authorised
27/05/2020 Qualification of novel methodologies for medicine development
27/05/2020 News and press releases: Prospective dialogue between developers and regulators makes for better evidence generation
27/05/2020 Minutes: Minutes of the PRAC meeting 25-28 November 2019
27/05/2020 Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 16, Authorised
27/05/2020 Human medicines European public assessment report (EPAR): Zeposia, ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting, 20/05/2020, Additional monitoring, Authorised
27/05/2020 Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, Orphan, Additional monitoring, Conditional approval, Authorised
27/05/2020 EPAR - Overview: Zolgensma : EPAR - Medicine overview
27/05/2020 Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Multiple Myeloma, 20/09/2018, Additional monitoring, Generic, 2, Authorised
27/05/2020 Human medicines European public assessment report (EPAR): Fulvestrant Mylan, fulvestrant, Breast Neoplasms, 08/01/2018, Generic, 2, Authorised
27/05/2020 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 27, Authorised
27/05/2020 News and press releases: EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines
27/05/2020 Committee for Medicinal Products for Human Use (CHMP): 25-28 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 25/05/2020 to 28/05/2020
27/05/2020 Agenda: Agenda - CHMP agenda of the 25-28 May 2020 meeting
26/05/2020 Other: European Medicines Agency’s privacy statement concerning requests for information or access to documents
26/05/2020 News and press releases: EMA calls for high-quality observational research in context of COVID-19
26/05/2020 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 18, Authorised
26/05/2020 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 21, Authorised
25/05/2020 Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan hydrochloride trihydrate, Pancreatic Neoplasms, 14/10/2016, Orphan, 5, Authorised
25/05/2020 Other: Record of data processing activity for the Small and Medium Enterprises Office (SME office) activities
25/05/2020 Other: European Medicines Agency’s Privacy Statement: Small and Medium Enterprises (SME) Office activities
25/05/2020 Summary of opinion: Zulvac BTV, Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3), 20/05/2020, Positive
25/05/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020
25/05/2020 Summary of opinion: Prevexxion RN, Marek's disease vaccine (live recombinant), 20/05/2020, Positive
25/05/2020 Summary of opinion: Prevexxion RN+HVT+IBD, Infectious bursal disease and Marek's disease vaccine (live recombinant), 20/05/2020, Positive
25/05/2020 Summary of opinion: Leucofeligen FeLV/RCP, feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated), 25/05/2020, Positive
25/05/2020 Summary of opinion: Aivlosin, tylvalosin, 20/05/2020, Positive
25/05/2020 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 5, Authorised
25/05/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 7, Authorised
25/05/2020 Report: Medicinal products for human use: monthly figures - April 2020
25/05/2020 Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo for the: Treatment of post-transplantation lymphoproliferative disorders, 14/07/2016, Withdrawn
25/05/2020 Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo- for the: Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Withdrawn
25/05/2020 Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz), levodopa, carbidopa, entacapone, Parkinson Disease, 11/11/2013, 7, Authorised
25/05/2020 Periodic safety update single assessment: Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201910
25/05/2020 Human medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline tartrate, Parkinson Disease, 04/04/2016, Generic, 3, Authorised
25/05/2020 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 7, Authorised
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
20/05/2020 Periodic safety update single assessment: Betamethasone / tetryzoline: List of nationally authorised medicinal products - PSUSA/00010072/201909
20/05/2020 Periodic safety update single assessment: Itopride: List of nationally authorised medicinal products - PSUSA/00010606/201906
20/05/2020 Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia, Iron Overload, 25/08/1999, 27, Authorised
20/05/2020 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010, Generic, 10, Authorised
20/05/2020 Human medicines European public assessment report (EPAR): Ongentys, opicapone, Parkinson Disease, 24/06/2016, Additional monitoring, 5, Authorised
20/05/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Ciclesonide
20/05/2020 Periodic safety update single assessment: Chlorquinaldol (vaginal tablet) / promestriene : List of nationally authorised medicinal products - PSUSA/00009272/201909
20/05/2020 Periodic safety update single assessment: Aminosalicylate sodium: List of nationally authorised medicinal products - PSUSA/00000165/201910
20/05/2020 Periodic safety update single assessment: Clenbuterol: List of nationally authorised medicinal products - PSUSA/00000794/201909
20/05/2020 Periodic safety update single assessment: Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201909
20/05/2020 Periodic safety update single assessment: Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201909
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
20/05/2020 Agenda: Agenda - European Medicines Agency and EuropaBio
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
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, CMDh final position, 25/03/2020, 20/05/2020
20/05/2020 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 10, Authorised
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
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)
19/05/2020 Regulatory and procedural guideline: Checklist for Initial Notifications for Parallel Distribution: Guidance for industry
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
19/05/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2020
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
19/05/2020 Other: Inventory of herbal substances for assessment
19/05/2020 Veterinary medicines European public assessment report (EPAR): Palladia, toceranib, 23/09/2009, 9, Authorised
19/05/2020 Human medicines European public assessment report (EPAR): Stalevo, levodopa, carbidopa, entacapone, Parkinson Disease, 17/10/2003, 26, Authorised
19/05/2020 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 9, Authorised
19/05/2020 Periodic safety update single assessment: Valsartan / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010735/201910
19/05/2020 Periodic safety update single assessment: Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201909
19/05/2020 Periodic safety update single assessment: Atenolol / chlortalidone: List of nationally authorised medicinal products - PSUSA/00000260/201909
19/05/2020 Human medicines European public assessment report (EPAR): Lonsurf, trifluridine, tipiracil hydrochloride, Colorectal Neoplasms, 25/04/2016, Additional monitoring, 5, Authorised
19/05/2020 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 5, Authorised
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
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
19/05/2020 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 8, Authorised
19/05/2020 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, Additional monitoring, 20, Authorised
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
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
19/05/2020 Periodic safety update single assessment: Busulfan: List of nationally authorised medicinal products - PSUSA/0464/201907
19/05/2020 Orphan designation: Human telomerase reverse transcriptase peptide (611-626) for the: Treatment of pancreatic cancer, 25/07/2006, Positive
19/05/2020 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, Patient safety, 21, Authorised
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 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
19/05/2020 Human medicines European public assessment report (EPAR): Osseor, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Withdrawn
19/05/2020 Public Statement: Public statement on Osseor: Withdrawal of the marketing authorisation in the European Union
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
18/05/2020 Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2019 meeting
18/05/2020 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 15, Authorised
18/05/2020 Regulatory and procedural guideline: HMPC rules of procedure
18/05/2020 Minutes: Minutes of the CAT meeting 19-21 February 2020
18/05/2020 Agenda: Agenda - CVMP agenda of the 18-20 May 2020 meeting
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
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
18/05/2020 EudraVigilance training and support
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
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
18/05/2020 Minutes: Minutes of the HMPC 13-15 January 2020 meeting
18/05/2020 Other: Expected publication dates of PRAC recommendations on safety signals
18/05/2020 Innovation in medicines
18/05/2020 Template or form: Innovation Task Force (ITF) briefing meeting request form
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
18/05/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
18/05/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
18/05/2020 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
18/05/2020 Periodic safety update single assessment: Pramiracetam: List of nationally authorised medicinal products - PSUSA/00002492/201909
18/05/2020 Transfer of marketing authorisation: questions and answers
18/05/2020 Risk management plan (RMP): questions and answers
18/05/2020 Post-authorisation safety studies (PASS)
18/05/2020 Post-authorisation measures: questions and answers
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
18/05/2020 Human medicines European public assessment report (EPAR): Ruconest, Recombinant human C1-inhibitor, Angioedemas, Hereditary, 28/10/2010, 10, Authorised
18/05/2020 Renewal and annual re-assessment of marketing authorisation
18/05/2020 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia, Arthritis, Gouty, Gout, 15/06/2017, Generic, 4, Authorised
18/05/2020 Grouping of variations: questions and answers
18/05/2020 Type-II variations: questions and answers
18/05/2020 Extensions of marketing authorisations: questions and answers
18/05/2020 Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, 13/11/2013, Additional monitoring, 11, Authorised
18/05/2020 Type-IB variations: questions and answers
18/05/2020 Type-IA variations: questions and answers
18/05/2020 Agenda: Agenda - CAT agenda of the 18-20 May 2020 meeting
18/05/2020 Agenda: Agenda - COMP agenda of the 18-20 May 2020 meeting
15/05/2020 Veterinary medicines European public assessment report (EPAR): Convenia, cefovecin, 19/06/2006, 12, Authorised
15/05/2020 Human medicines European public assessment report (EPAR): Xultophy, insulin degludec, liraglutide, Diabetes Mellitus, Type 2, 18/09/2014, 14, Authorised
15/05/2020 Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 23/01/2019, Initial authorisation
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
15/05/2020 Human medicines European public assessment report (EPAR): Protelos, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Withdrawn
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 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
15/05/2020 Minutes: Minutes of the COMP meeting 17-19 March 2020
15/05/2020 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 16, Authorised
15/05/2020 Orphan designation: Itraconazole for the: Prevention of invasive aspergillosis, 25/05/2018, Positive
15/05/2020 Maximum Residue Limits - Report: Ciclesonide (equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP
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
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
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
14/05/2020 Recruitment: Decision of the Executive Director on rules governing the traineeship programme at the EMA
14/05/2020 Recruitment: Traineeship - Frequently asked questions (FAQs)
14/05/2020 Other: Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)
14/05/2020 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 39, Authorised
14/05/2020 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 17, Authorised
14/05/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2020
14/05/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Bambermycin
14/05/2020 Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 16, Authorised
14/05/2020 Maximum Residue Limits - Report: Bambermycin (rabbit): European public maximum-residue-limit assessment report (EPMAR) - CVMP
14/05/2020 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 46, Authorised
14/05/2020 Other: Extension of reserve lists for external selection procedures: Temporary Agent reserve lists
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
14/05/2020 Annual Report: Annual report of the Good Clinical Practice Inspectors' Working Group 2018
14/05/2020 Good manufacturing practice
14/05/2020 Human medicines European public assessment report (EPAR): Forsteo, teriparatide, Osteoporosis, Osteoporosis, Postmenopausal, 10/06/2003, 21, Authorised
14/05/2020 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 20, Authorised
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
13/05/2020 Veterinary medicines European public assessment report (EPAR): Stelfonta, tigilanol tiglate, 15/01/2020, 1, Authorised
13/05/2020 Other: Record of data processing activity relating to trainings (public)
13/05/2020 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Additional monitoring, Biosimilar, 3, Authorised
13/05/2020 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 37, Authorised
13/05/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2020
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
13/05/2020 Agenda: Agenda - Enpr-EMA Coordinating Group & networks meeting on 21 February 2020
13/05/2020 Orphan designation: pasireotide for the: Treatment of acromegaly, 08/10/2009, Positive
13/05/2020 Orphan designation: pasireotide for the: Treatment of Cushing's disease, 08/10/2009, Positive
13/05/2020 Minutes: Minutes of the CAT meeting 18-20 March 2020
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 Work programme: Work Plan 2020 of the Good Clinical Practice Inspectors' Working Group
12/05/2020 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Skin Diseases, Bacterial, 16/12/2019, Additional monitoring, 1, Authorised
12/05/2020 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 21/03/2014, 19, Authorised
12/05/2020 Human medicines European public assessment report (EPAR): Palonosetron Accord, Palonosetron, Vomiting, Nausea, Cancer, 26/05/2016, Generic, 3, Authorised
12/05/2020 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 10, Authorised
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
12/05/2020 Veterinary medicines European public assessment report (EPAR): Acticam, meloxicam, 09/12/2008, Generic, 8, Authorised
12/05/2020 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 31, Authorised
12/05/2020 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 3, Authorised
11/05/2020 Compassionate use
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
11/05/2020 Newsletter: Human medicines highlights - May 2020
11/05/2020 Newsletter: Public bulletin: Veterinary pharmacovigilance 2019
11/05/2020 Newsletter: Public bulletin: Veterinary pharmacovigilance 2019
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
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
11/05/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC meeting
11/05/2020 Periodic safety update single assessment: Oxcarbazepinexcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/201908
11/05/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC
11/05/2020 Agenda: Agenda - PRAC draft agenda of meeting 11-14 May 2020
11/05/2020 Big data
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
08/05/2020 Periodic safety update single assessment: Brivudine: List of nationally authorised medicinal products - PSUSA/00000434/201907
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
08/05/2020 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 2, Authorised
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
08/05/2020 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 12, Authorised