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30/05/2019 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 2, Authorised (updated)
30/05/2019 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 19, Authorised (updated)
30/05/2019 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 18, Authorised (updated)
30/05/2019 Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis), vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 19, Authorised (updated)
30/05/2019 Periodic safety update single assessment: Mirtazapine: List of nationally authorised medicinal products - PSUSA/00002068/201808
30/05/2019 Human medicines European public assessment report (EPAR): Orbactiv, oritavancin diphosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 18/03/2015, Additional monitoring, 6, Authorised (updated)
30/05/2019 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, Additional monitoring, 2, Authorised (updated)
29/05/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
29/05/2019 Summary of opinion: Cufence, trientine dihydrochloride, 29/05/2019, Positive
29/05/2019 Summary of opinion: Doxolipad, doxorubicin, 31/01/2019, Negative (updated)
29/05/2019 Withdrawn application: Ambrisentan Zentiva, ambrisentan, Date of withdrawal: 29/04/2019, Initial authorisation
29/05/2019 Summary of opinion: Posaconazole Accord, posaconazole, 29/05/2019, Positive
29/05/2019 Summary of opinion: Posaconazole AHCL, posaconazole, 29/05/2019, Positive
29/05/2019 Referral: Methocarbamol / paracetamol-containing medicinal products , methocarbamol/paracetamol , Robaxisal compuesto, Article 31 referrals, Procedure started, 29/05/2019
29/05/2019 Withdrawn application: Radicava, edaravone, Date of withdrawal: 24/05/2019, Initial authorisation
29/05/2019 Summary of opinion: Xyndari, glutamine, 29/05/2019, Negative
29/05/2019 Summary of opinion: LysaKare, arginine / lysine, 29/05/2019, Positive
29/05/2019 Changing the name or address of a sponsor (updated)
29/05/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin) (updated)
29/05/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin) (updated)
29/05/2019 Medicine for use outside EU: List of medicinal products under additional monitoring (updated)
29/05/2019 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
29/05/2019 List of medicines under additional monitoring (updated)
29/05/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
29/05/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
29/05/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union (updated)
29/05/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union (updated)
29/05/2019 Human medicines European public assessment report (EPAR): Palynziq, Pegvaliase, Phenylketonurias, 03/05/2019, Orphan, Additional monitoring, Authorised (updated)
29/05/2019 Orphan designation: Pegylated recombinant phenylalanine ammonia lyase (pegvaliase) for the: Treatment of hyperphenylalaninaemia, 28/01/2010, Positive (updated)
29/05/2019 Scientific guideline: Qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device
29/05/2019 Overview of comments: Overview of comments on 'Stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device' (EMA/532515/2018)
29/05/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: May 2019
29/05/2019 Opinion/decision on a Paediatric investigation plan (PIP): Carotuximab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0383/2017 (updated)
29/05/2019 Paediatric Committee (PDCO): 27-29 May 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 27/05/2019 to 29/05/2019 (updated)
29/05/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 April 2019
29/05/2019 Paediatric Committee (PDCO): 23-26 April 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 23/04/2019 to 26/04/2019 (updated)
29/05/2019 Agenda: Agenda - PDCO agenda of the 27-29 May 2019 meeting
29/05/2019 Opinion/decision on a Paediatric investigation plan (PIP): Betrixaban, PM: decision on the application for modification of an agreed PIP, P/0168/2018 (updated)
29/05/2019 Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/07/2016, Generic, 5, Authorised (updated)
28/05/2019 Human medicines European public assessment report (EPAR): Revolade, Eltrombopag olamine, Purpura, Thrombocytopenic, Idiopathic, 11/03/2010, Orphan, 23, Authorised (updated)
28/05/2019 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 34, Authorised (updated)
28/05/2019 Human medicines European public assessment report (EPAR): Daklinza, daclatasvir dihydrochloride, Hepatitis C, Chronic, 22/08/2014, Additional monitoring, 14, Authorised (updated)
28/05/2019 Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, 24/06/2009, 13, Authorised (updated)
28/05/2019 News and press releases: EMA closed 30-31 May 2019
28/05/2019 Careers (updated)
28/05/2019 Online training: How to submit an 'annual update' for parallel distribution via IRIS , European Medicines Agency, Amsterdam, the Netherlands, from 29/04/2019 to 29/04/2019
27/05/2019 Periodic safety update single assessment: Everolimus (indicated for rejection of transplanted organs) : List of nationally authorised medicinal products - PSUSA/00010269/201807
27/05/2019 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 35, Authorised (updated)
27/05/2019 Scientific guideline: Draft etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance
27/05/2019 Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
27/05/2019 Human medicines European public assessment report (EPAR): Sustiva, efavirenz, HIV Infections, 28/05/1999, 44, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 2, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Pifeltro, Doravirine, HIV Infections, 22/11/2018, Additional monitoring, 1, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 2, Authorised (updated)
27/05/2019 Agenda: Agenda - CHMP agenda of the 27-29 May 2019 meeting
27/05/2019 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 43, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, Additional monitoring, 8, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 35, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Schizophrenia, Bipolar Disorder, 20/08/2015, Generic, 6, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, 22/05/2014, Generic, 11, Authorised (updated)
27/05/2019 Orphans: Regulatory and procedural guidance and forms (updated)
27/05/2019 Orphan designation: avapritinib for the: Treatment of mastocytosis, 26/10/2018, Positive (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration, Macular Edema, Myopia, Degenerative, Diabetes Complications, 22/01/2007, 31, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Fluenz Tetra, reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human, 04/12/2013, 16, Authorised (updated)
27/05/2019 Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 15, Authorised (updated)
27/05/2019 Orphan designation: Human plasma-derived alpha-1 proteinase inhibitor for the: Treatment of graft-versus-host disease, 19/03/2015, Positive (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 15, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka), irbesartan hydrochloride, Hypertension, 01/12/2008, Generic, 10, Authorised (updated)
24/05/2019 Innovation in medicines (updated)
24/05/2019 Antimicrobial resistance in human medicine (updated)
24/05/2019 News and press releases: EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
24/05/2019 Human medicines European public assessment report (EPAR): Lonsurf, trifluridine, tipiracil hydrochloride, Colorectal Neoplasms, 25/04/2016, Additional monitoring, 3, Authorised (updated)
24/05/2019 Template or form: Letter of intent for the submission of a work sharing procedure to the European Medicines Agency according to Article 20 of Commission Regulation (EC) No 1234/2008 - Veterinary applications (updated)
24/05/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 2019
24/05/2019 Summary of opinion: Nasym, bovine respiratory syncytial virus vaccine (live), freeze-dried, 24/05/2019, Positive
24/05/2019 Summary of opinion: Bravecto Plus,  fluralaner / moxidectin , 24/05/2019, Positive
24/05/2019 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, Additional monitoring, 6, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Exforge, amlodipine (as besylate), valsartan, Hypertension, 16/01/2007, 23, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Fosavance, alendronic acid, colecalciferol, Osteoporosis, Postmenopausal, 24/08/2005, 21, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Additional monitoring, Conditional approval, 3, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Aspergillosis, Candidiasis, Mycoses, 16/05/2013, Generic, 11, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, 19/01/2015, Orphan, Additional monitoring, 10, Authorised (updated)
24/05/2019 Human medicines European public assessment report (EPAR): Orgalutran, ganirelix, Reproductive Techniques, Assisted, Ovulation Induction, 16/05/2000, 19, Authorised (updated)
24/05/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019 , European Medicines Agency, from 19/02/2019 to 21/02/2019 (updated)
24/05/2019 Summary of opinion: Evicto, selamectin, 24/05/2019, Positive
24/05/2019 Referrals document: Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol (EMEA/H/A-5(3)/1477) (updated)
24/05/2019 Committee for Advanced Therapies (CAT): 22-24 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/05/2019 to 24/05/2019 (updated)
24/05/2019 Agenda: Agenda - CAT agenda of the 22-24 May 2019 meeting
24/05/2019 Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 4, Authorised (updated)
24/05/2019 Periodic safety update single assessment: Diclofenac / omeprazole: List of nationally authorised medicinal products - PSUSA/00010461/201809
24/05/2019 Periodic safety update single assessment: Acetylcysteine: List of nationally authorised medicinal products - PSUSA/00000034/201809
23/05/2019 Minutes: Minutes of the CHMP meeting 25-28 March 2019
23/05/2019 Committee for Medicinal Products for Human Use (CHMP): 25-28 March 2019 , European Medicines Agency, from 25/03/2019 to 28/03/2019 (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Sirturo, bedaquiline fumarate, Tuberculosis, Multidrug-Resistant, 05/03/2014, Orphan, Additional monitoring, Conditional approval, 15, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 28, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 9, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop), docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 20/04/2007, 30, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), irbesartan, hydrochlorothiazide, Hypertension, 18/01/2007, 24, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, 31/08/2018, Additional monitoring, 1, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 4, Authorised (updated)
23/05/2019 Orphan designation: Recombinant protein consisting of modified human growth hormone releasing hormone and the translocation and endopeptidase domains of botulinum toxin serotype D for the: Treatment of acromegaly, 11/01/2012, Withdrawn (updated)
23/05/2019 Orphan designation: PEGylated recombinant factor VIII (turoctocog alfa pegol) for the: Treatment of haemophilia A, 26/04/2012, Withdrawn (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 14, Authorised (updated)
23/05/2019 Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Breast Neoplasms, 06/05/2019, Generic, Authorised
23/05/2019 Orphan designation: Palovarotene for the: Treatment of multiple osteochondromas, 27/06/2018, Positive (updated)
23/05/2019 Orphan designation: Recombinant human acid alpha-glucosidase for the: Treatment of glycogen storage disease type II (Pompe's disease), 21/03/2018, Positive (updated)
23/05/2019 Orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for the: Treatment of congenital hyperinsulinism, 25/05/2018, Positive (updated)
23/05/2019 Orphan designation: Efpegsomatropin for the: Treatment of growth hormone deficiency, 27/06/2018, Positive (updated)
23/05/2019 Orphan designation: Volanesorsen sodium for the: Treatment of familial partial lipodystrophy, 14/07/2016, Positive (updated)
23/05/2019 Orphan designation: Siplizumab for the: Treatment in solid organ transplantation, 16/10/2017, Positive (updated)
23/05/2019 Orphan designation: Brincidofovir for the: Prevention of cytomegalovirus disease, 28/04/2016, Positive (updated)
23/05/2019 Orphan designation: Fosbretabulin tromethamine for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 21/03/2016, Positive (updated)
23/05/2019 Orphan designation: Brincidofovir for the: treatment of smallpox, 18/11/2016, Positive (updated)
23/05/2019 Orphan designation: Brincidofovir for the: Treatment of adenovirus infection in immunocompromised patients, 14/07/2016, Positive (updated)
23/05/2019 Orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene, 30/05/2016, Positive (updated)
22/05/2019 Regulatory and procedural guideline: IRIS quick guide to the portal for orphan industry users (updated)
22/05/2019 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 38, Authorised (updated)
22/05/2019 Human medicines European public assessment report (EPAR): Baraclude, Entecavir, Hepatitis B, Chronic, 26/06/2006, 24, Authorised (updated)
22/05/2019 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 37, Authorised (updated)
22/05/2019 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 21, Authorised (updated)
22/05/2019 Orphan designation: Fibrinogen-coated albumin spheres for the: Treatment of acute radiation syndrome, 10/08/2015, Positive (updated)
22/05/2019 Orphan designation: Fibrinogen-coated albumin spheres for the: Treatment of Ebola virus disease, 12/02/2015, Positive (updated)
22/05/2019 Orphan designation: Gemfibrozil for the: Treatment of neuronal ceroid lipofuscinosis, 21/03/2018, Positive (updated)
22/05/2019 Periodic safety update single assessment: Clenbuterol: List of nationally authorised medicinal products - PSUSA/00000794/201809
22/05/2019 Periodic safety update single assessment: Sodium oxybate (intravenous use): List of nationally authorised medicinal products - PSUSA/00010613/201810
22/05/2019 Periodic safety update single assessment: Asparaginase, crisantaspase, pegaspargase (nationally authorised products): List of nationally authorised medicinal products - PSUSA/00003161/201808
22/05/2019 Orphan designation: Sinapultide, dipalmitoylphosphatidylcholine palmitoyl-oleoyl phosphatidylglycerol, sodium salt and palmitic acid for the: Treatment of cystic fibrosis, 27/10/2011, Positive (updated)
22/05/2019 Orphan designation: Sinapultide, dipalmitoylphosphatidylcholine, palmitoyloleoy phosphatidylglycerol and palmitic acid for the: Respiratory distress syndrome in premature neonates of less then 37 weeks of gestational age, 29/07/2004, Positive (updated)
22/05/2019 Orphan designation: Deferiprone for the: Treatment of neurodegeneration with brain iron accumulation, 27/06/2018, Positive (updated)
22/05/2019 Orphan designation: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine  (avapritinib)  for the: Treatment of gastrointestinal stromal tumours, 17/07/2017, Positive (updated)
22/05/2019 Orphan designation: Sinapultide, dipalmitoylphosphatidylcholine, palmitoyloleoy phosphatidylglycerol and palmitic acid for the: Respiratory distress syndrome in premature neonates of less than 32 weeks of gestational age, 29/07/2004, Positive (updated)
22/05/2019 Orphan designation: Sinapultide, dipalmitoylphosphatidylcholine, palmitoyloleoy phosphatidylglycerol and palmitic acid for the: Treatment of acute lung Injury, 04/02/2002, Positive (updated)
22/05/2019 Veterinary medicines European public assessment report (EPAR): ReproCyc ParvoFLEX, Porcine parvovirus, strain 27a, viral protein 2, Authorised
22/05/2019 Regulatory and procedural guideline: The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products (updated)
22/05/2019 Periodic safety update single assessment: Misoprostol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010353/201805
22/05/2019 Periodic safety update single assessment: Misoprostol: List of nationally authorised medicinal products - PSUSA/00010353/201805
22/05/2019 Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/09/2015, Generic, 4, Authorised (updated)
22/05/2019 Periodic safety update single assessment: Ivermectin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010376/201804
22/05/2019 Periodic safety update single assessment: Ivermectin: List of nationally authorised medicinal products - PSUSA/00010376/201804
21/05/2019 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 59, Authorised (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 5, Authorised (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Neparvis, sacubitril, valsartan, Heart Failure, 26/05/2016, Additional monitoring, 8, Authorised (updated)
21/05/2019 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, Generic, 4, Authorised (updated)
21/05/2019 Orphan designation: Adeno-associated viral vector serotype 9 containing the human HGSNAT gene for the: Treatment of mucopolysaccharidosis IIIC (Sanfilippo C syndrome), 21/05/2015, Positive (updated)
21/05/2019 Veterinary medicines European public assessment report (EPAR): MS-H Vaccine, Mycoplasma synoviae strain MS-H, 14/06/2011, 5, Authorised (updated)
21/05/2019 Orphan designation: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate for the treatment of acute myeloid leukaemia- for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive (updated)
21/05/2019 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary sclerosing cholangitis, 14/12/2015, Positive (updated)
21/05/2019 Orphan designation: edaravone for the: Treatment of amyotrophic lateral sclerosis, 19/06/2015, Positive (updated)
21/05/2019 Orphan designation: Tamibarotene for the: Treatment of acute myeloid leukaemia, 31/07/2018, Positive
21/05/2019 Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, Patient safety, 16, Authorised
21/05/2019 Orphan designation: Combretastatin A1 diphosphate- for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive
21/05/2019 Orphan designation: Isavuconazonium sulfate for the: Treatment of invasive aspergillosis, 04/07/2014, Positive
21/05/2019 Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive
21/05/2019 Orphan designation: Isavuconazonium sulfate for the: Treatment of mucormycosis, 04/06/2014, Positive
21/05/2019 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene for the: Treatment of mucopolysaccharidosis IIIA (Sanfilippo A syndrome), 10/06/2014, Positive
21/05/2019 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, 2, Authorised
21/05/2019 Orphan designation: Forodesine for the: Treatment of chronic lymphocytic leukaemia, 20/09/2010, Positive
21/05/2019 Orphan designation: Cysteamine for the: Treatment of cystic fibrosis, 09/12/2011, Positive
21/05/2019 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, Additional monitoring, 6, Authorised
21/05/2019 Orphan designation: Forodesine hydrochloride for the: Treatment of cutaneous T cell lymphoma, 29/01/2007, Positive
21/05/2019 Orphan designation: Forodesine hydrochloride for the: Treatment of acute lymphoblastic leukaemia, 18/12/2006, Positive
21/05/2019 Orphan designation: Recombinant adeno-associated viral vector containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 08/02/2013, Positive
21/05/2019 Orphan designation: miglustat for the: Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive
21/05/2019 Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 10, Authorised
21/05/2019 Orphan designation: 1-Deoxygalactonojirimycin hydrochloride for the: Treatment of Fabry disease, 22/05/2006, Positive
21/05/2019 Periodic safety update single assessment: Tiapride: List of nationally authorised medicinal products - PSUSA/00002944/201807
21/05/2019 Orphan designation: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol for the: Treatment of anaplastic thyroid cancer, 14/04/2004, Positive
21/05/2019 Periodic safety update single assessment: Erythromycin / isotretinoin, isotretinoin (topical formulations): List of nationally authorised medicinal products - PSUSA/00010487/201808
21/05/2019 Agenda: Agenda - CVMP agenda of the 21-22 May 2019 meeting
21/05/2019 Periodic safety update single assessment: Meropenem: List of nationally authorised medicinal products - PSUSA/00001989/201808
21/05/2019 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 28, Authorised
21/05/2019 Periodic safety update single assessment: Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201805
21/05/2019 Periodic safety update single assessment: Dienogest / estradiol (contraception indication): List of nationally authorised medicinal products - PSUSA/00010444/201809
21/05/2019 Human medicines European public assessment report (EPAR): Revinty Ellipta, fluticasone furoate, vilanterol trifenatate, Asthma, 02/05/2014, 17, Authorised
21/05/2019 Periodic safety update single assessment: Opium: List of nationally authorised medicinal products - PSUSA/00010670/201808
21/05/2019 Human medicines European public assessment report (EPAR): Insuman, insulin human, Diabetes Mellitus, 21/02/1997, 27, Authorised
21/05/2019 Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 3, Authorised
21/05/2019 Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 23/02/1998, 33, Authorised
20/05/2019 Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 13/10/1997, 31, Authorised
20/05/2019 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 28, Authorised
20/05/2019 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 16, Authorised
20/05/2019 Regulatory and procedural guideline: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2019-2020
20/05/2019 Submission deadlines for orphan designations
20/05/2019 Annual Report: 2018 annual report of the European Medicines Agency
20/05/2019 Report: Medicinal products for human use: monthly figures - April 2019
20/05/2019 Agenda: Agenda - COMP agenda of the 21-23 May 2019 meeting
20/05/2019 Annual Report: Annex 10 – 2018 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
20/05/2019 News and press releases: Update of EU recommendations for 2019–2020 seasonal flu vaccine composition
20/05/2019 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 2019/2020
20/05/2019 Human medicines European public assessment report (EPAR): Waylivra, Volanesorsen sodium, Hyperlipoproteinemia Type I, 03/05/2019, Orphan, Additional monitoring, Authorised
20/05/2019 Orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (volanesorsen) for the: Treatment of familial chylomicronaemia syndrome, 19/02/2014, Positive
20/05/2019 Presentation: Presentation - The summary-of-product-characteristics guideline and paediatric aspects
20/05/2019 Other: Frequently asked questions on SmPC paediatric information
17/05/2019 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 7, Authorised
17/05/2019 Orphan designation: Adenovirus associated viral vector serotype 5 containing the human RPE65 gene for the: Treatment of leber's congenital amaurosis, 11/11/2015, Positive
17/05/2019 Orphan designation: Adenovirus-associated viral vector serotype 5 containing the human RPGR gene for the: Treatment of retinitis pigmentosa, 29/08/2016, Positive
17/05/2019 Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone for the: Treatment in haematopoietic stem cell transplantation, 18/11/2016, Positive
17/05/2019 Orphan designation: (Manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-) (misopasem manganese) for the: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy, 31/01/2008, Positive
17/05/2019 Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, European Commission final decision, 31/01/2019, 02/04/2019, 17/05/2019
17/05/2019 Orphan designation: Adenovirus associated viral vector serotype 8 containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 11/11/2015, Positive
17/05/2019 Orphan designation: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene for the: Treatment of achromatopsia, 31/07/2018, Positive
17/05/2019 Orphan designation: Adenovirus associated viral vector serotype 8 containing the human AIPL1 gene for the: Treatment of leber's congenital amaurosis, 12/12/2017, Positive
17/05/2019 Orphan designation: Phosphorothioate oligonucleotide targeted to transthyretin (inotersen) for the: Treatment of ATTR amyloidosis, 26/03/2014, Positive
17/05/2019 Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 09/09/2013, Biosimilar, 21, Authorised
17/05/2019 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 17, Authorised
17/05/2019 Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 18/09/2013, Additional monitoring, 12, Authorised
17/05/2019 Human medicines European public assessment report (EPAR): Pregabalin Mylan, pregabalin, Anxiety Disorders, Epilepsy, 24/06/2015, Generic, 7, Authorised
17/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus L4, Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated), 30/07/2014, 4, Authorised
17/05/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet, Article 31 referrals, Under evaluation, 17/05/2019
17/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus Pi/L4R, Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 and rabies virus, strain SAD Vnukovo-32 (all inactivated), 30/07/2014, 5, Authorised
17/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus Pi/L4, Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated), 30/07/2014, 4, Authorised
17/05/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019
17/05/2019 Referral: Xeljanz , tofacitinib , Article 20 procedures, Procedure started
17/05/2019 News and press releases: Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs
17/05/2019 News and press releases: Withdrawal of marketing authorisations for fenspiride medicines
17/05/2019 Newsletter: Public bulletin: Veterinary pharmacovigilance 2018
16/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus Pi, canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated), 03/07/2014, 5, Authorised
16/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi/L4R, canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091..., 06/05/2014, 6, Authorised
16/05/2019 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes
16/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi/L4, canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091..., 06/05/2014, 6, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, Additional monitoring, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 2, Authorised
16/05/2019 Veterinary medicines European public assessment report (EPAR): Forceris, toltrazuril, iron (III) ion, 23/04/2019, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections, 04/02/2002, 52, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity, Overweight, 23/03/2015, Additional monitoring, 6, Authorised
16/05/2019 Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi, canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), 03/07/2014, 7, Authorised
16/05/2019 Administration and Corporate Management
16/05/2019 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 46, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 8, Authorised
16/05/2019 Veterinary medicines European public assessment report (EPAR): Simparica, sarolaner, 06/11/2015, 6, Authorised
16/05/2019 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Osteoporosis, 16/12/2014, 8, Authorised
15/05/2019 Human medicines European public assessment report (EPAR): Selincro, Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders, 24/02/2013, 11, Authorised
15/05/2019 Herbal medicinal product: Fragariae folium, Fragariae folium, F: Assessment finalised
15/05/2019 Veterinary medicines European public assessment report (EPAR): MiPet Easecto, sarolaner, 31/01/2018, 1, Authorised
15/05/2019 Veterinary medicines European public assessment report (EPAR): Apoquel, oclacitinib maleate, 12/09/2013, 5, Authorised
15/05/2019 Veterinary medicines European public assessment report (EPAR): Melosus, meloxicam, 21/02/2011, Generic, 6, Authorised
15/05/2019 Veterinary medicines European public assessment report (EPAR): Chanhold, selamectin, 17/04/2019, Authorised
15/05/2019 Human medicines European public assessment report (EPAR): Bortezomib Hospira, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 7, Authorised
15/05/2019 Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir sulfate, HIV Infections, 25/03/2019, Generic, Authorised
15/05/2019 Clinical pharmacology and pharmacokinetics: questions and answers
14/05/2019 Human medicines European public assessment report (EPAR): Truvada, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 20/02/2005, 40, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 32, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, 11/01/2008, 18, Authorised
14/05/2019 Veterinary medicines European public assessment report (EPAR): Felisecto Plus, selamectin, sarolaner, 26/04/2019, Authorised
14/05/2019 Veterinary medicines European public assessment report (EPAR): Suprelorin, deslorelin acetate, 10/07/2007, 12, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 10, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 14/02/2019, Additional monitoring, Biosimilar, 1, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 4, Authorised
14/05/2019 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 18/08/2016, 7, Authorised