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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the translocation and endopeptidase domains of botulinum toxin serotype D for the: Treatment of acromegaly, 11/01/2012, Withdrawn (updated)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designation: PEGylated recombinant factor VIII (turoctocog alfa pegol) for the: Treatment of haemophilia A, 26/04/2012, Withdrawn (updated)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)
23/05/2019 Orphan designation: Human/murine chimeric monoclonal antibody against endoglin (carotuximab) for the: Treatment of soft tissue sarcoma, 28/04/2016, Positive (updated)
23/05/2019 Careers (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 Scientific publications (updated)
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 (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, Patient safety, 16, Authorised (updated)
21/05/2019 Orphan designation: Combretastatin A1 diphosphate- for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive (updated)
21/05/2019 Orphan designation: Isavuconazonium sulfate for the: Treatment of invasive aspergillosis, 04/07/2014, Positive (updated)
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 (updated)
21/05/2019 Orphan designation: Isavuconazonium sulfate for the: Treatment of mucormycosis, 04/06/2014, Positive (updated)
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 (updated)
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 (updated)
21/05/2019 Orphan designation: Forodesine for the: Treatment of chronic lymphocytic leukaemia, 20/09/2010, Positive (updated)
21/05/2019 Orphan designation: Cysteamine for the: Treatment of cystic fibrosis, 09/12/2011, Positive (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, Additional monitoring, 6, Authorised (updated)
21/05/2019 Orphan designation: Forodesine hydrochloride for the: Treatment of cutaneous T cell lymphoma, 29/01/2007, Positive (updated)
21/05/2019 Orphan designation: Forodesine hydrochloride for the: Treatment of acute lymphoblastic leukaemia, 18/12/2006, Positive (updated)
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 (updated)
21/05/2019 Orphan designation: miglustat for the: Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive (updated)
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 (updated)
21/05/2019 Orphan designation: 1-Deoxygalactonojirimycin hydrochloride for the: Treatment of Fabry disease, 22/05/2006, Positive (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
21/05/2019 Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 23/02/1998, 33, Authorised (updated)
20/05/2019 Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 13/10/1997, 31, Authorised (updated)
20/05/2019 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 28, Authorised (updated)
20/05/2019 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 16, Authorised (updated)
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 (updated)
20/05/2019 Submission deadlines for orphan designations (updated)
20/05/2019 Annual Report: 2018 annual report of the European Medicines Agency (updated)
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 (updated)
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 (updated)
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 (updated)
20/05/2019 Presentation: Presentation - The summary-of-product-characteristics guideline and paediatric aspects (updated)
20/05/2019 Other: Frequently asked questions on SmPC paediatric information (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
17/05/2019 Orphan designation: Phosphorothioate oligonucleotide targeted to transthyretin (inotersen) for the: Treatment of ATTR amyloidosis, 26/03/2014, Positive (updated)
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 (updated)
17/05/2019 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 17, Authorised (updated)
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 (updated)
17/05/2019 Human medicines European public assessment report (EPAR): Pregabalin Mylan, pregabalin, Anxiety Disorders, Epilepsy, 24/06/2015, Generic, 7, Authorised (updated)
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 (updated)
17/05/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet, Article 31 referrals, Under evaluation, 17/05/2019 (updated)
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 (updated)
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 (updated)
17/05/2019 Referral: Fenspiride containing medicinal products , fenspiride , Article 107i procedures, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 17/05/2019 (updated)
17/05/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019
17/05/2019 Other: PRAC statistics: 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 (updated)
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 (updated)
16/05/2019 Procurement (updated)
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 (updated)
16/05/2019 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
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 (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 2, Authorised (updated)
16/05/2019 Veterinary medicines European public assessment report (EPAR): Forceris, toltrazuril, iron (III) ion, 23/04/2019, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections, 04/02/2002, 52, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity, Overweight, 23/03/2015, Additional monitoring, 6, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Ilaris, Canakinumab, Cryopyrin-Associated Periodic Syndromes, Arthritis, Juvenile Rheumatoid, Arthritis, Gouty, 23/10/2009, 22, Authorised (updated)
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 (updated)
16/05/2019 Administration and Corporate Management (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Revolade, Eltrombopag olamine, Purpura, Thrombocytopenic, Idiopathic, 11/03/2010, Orphan, 22, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 46, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 8, Authorised (updated)
16/05/2019 Veterinary medicines European public assessment report (EPAR): Simparica, sarolaner, 06/11/2015, 6, Authorised (updated)
16/05/2019 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Osteoporosis, 16/12/2014, 8, Authorised (updated)
15/05/2019 Human medicines European public assessment report (EPAR): Selincro, Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders, 24/02/2013, 11, Authorised (updated)
15/05/2019 Herbal medicinal product: Fragariae folium, Fragariae folium, F: Assessment finalised (updated)
15/05/2019 Veterinary medicines European public assessment report (EPAR): MiPet Easecto, sarolaner, 31/01/2018, 1, Authorised (updated)
15/05/2019 Veterinary medicines European public assessment report (EPAR): Apoquel, oclacitinib maleate, 12/09/2013, 5, Authorised (updated)
15/05/2019 Veterinary medicines European public assessment report (EPAR): Melosus, meloxicam, 21/02/2011, Generic, 6, Authorised (updated)
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 (updated)
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 (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Truvada, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 20/02/2005, 40, Authorised (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 32, Authorised (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, 11/01/2008, 18, Authorised (updated)
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 (updated)
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 (updated)
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 (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 4, Authorised (updated)
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 (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic, 08/06/2001, 41, Authorised (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Breast Neoplasms, 09/03/2004, 20, Authorised (updated)
14/05/2019 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, Additional monitoring, 6, Authorised (updated)
13/05/2019 Minutes: Minutes of the COMP meeting 19-21 February 2019
13/05/2019 Report: Applications for new human medicines under evaluation by the CHMP: May 2019
13/05/2019 Agenda: Agenda - PRAC draft agenda of meeting 13-16 May 2019
13/05/2019 Human medicines European public assessment report (EPAR): Relvar Ellipta, fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive, 13/11/2013, 18, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, Additional monitoring, 6, Authorised (updated)
13/05/2019 Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester for the: Treatment of pulmonary arterial hypertension, 20/04/2017, Positive (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 11, Authorised (updated)
13/05/2019 Orphan designation: Adeno-associated viral vector serotype 8 containing the human alpha-galactosidase A gene for the: Treatment of Fabry disease, 20/03/2017, Positive (updated)
13/05/2019 Orphan designation: 9-cis-Retinyl acetate for the: Treatment of leber's congenital amaurosis, 13/05/2011, Positive (updated)
13/05/2019 Orphan designation: 9-cis-Retinyl acetate for the: Treatment of retinitis pigmentosa, 13/05/2011, Positive (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Ameluz, 5-aminolevulinic acid hydrochloride, Keratosis, Actinic, Carcinoma, Basal Cell, 13/12/2011, 14, Authorised (updated)
13/05/2019 Orphan designation: Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene for the: Treatment of Crigler-Najjar syndrome, 18/11/2016, Positive (updated)
13/05/2019 Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant for the: Treatment of haemophilia B, 26/10/2018, Positive (updated)
13/05/2019 Orphan designation: Adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene for the: Treatment of catecholaminergic polymorphic ventricular tachycardia, 29/07/2014, Positive (updated)
13/05/2019 Orphan designation: Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p for the: Treatment of cutaneous T-cell lymphoma, 22/05/2017, Positive (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Fractures, Bone, 23/08/2012, Generic, 8, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Ledaga, Chlormethine, Mycosis Fungoides, 03/03/2017, Orphan, 4, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Macular Edema, Uveitis, 26/07/2010, 11, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Dacogen, Decitabine, Leukemia, Myeloid, 20/09/2012, Orphan, 13, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 45, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Mirvaso, brimonidine tartrate, Skin Diseases, 20/02/2014, 10, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Prialt, ziconotide, Injections, Spinal, Pain, 21/02/2005, Orphan, 23, Authorised (updated)
13/05/2019 Veterinary medicines European public assessment report (EPAR): Clomicalm, clomipramine, 01/04/1998, 15, Authorised (updated)
13/05/2019 Veterinary medicines European public assessment report (EPAR): Eryseng Parvo, porcine parvovirus, strain NADL-2 and Erysipelothrix rhusiopathiae, strain R32E11 (inactivated), 08/07/2014, 5, Authorised (updated)
13/05/2019 Regulatory and procedural guideline: Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP) (updated)
13/05/2019 Other: Mandate, objectives and composition of the Patients and Consumers Working Party (PCWP) (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, 8, Authorised (updated)
13/05/2019 Other: Mandate, objectives and composition of the Healthcare Professionals Working Party (HCPWP) (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias, Hypercholesterolemia, 17/07/2015, Additional monitoring, 9, Authorised (updated)
13/05/2019 Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), Thalidomide, Multiple Myeloma, 16/04/2008, Orphan, 23, Authorised (updated)
13/05/2019 Orphan designation: (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride (derazantinib) for the: Treatment of biliary tract cancer, 30/05/2016, Positive (updated)
13/05/2019 Orphan designation: S-Nitrosoglutathione for the: Treatment of pre-eclampsia, 13/05/2011, Positive (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, Additional monitoring, 16, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 26, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Iasibon, ibandronic acid, Hypercalcemia, Fractures, Bone, Neoplasm Metastasis, Breast Neoplasms, 21/01/2011, Generic, 8, Authorised (updated)
10/05/2019 Other: Article 57 product data (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, 19/09/2018, Additional monitoring, 2, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, Generic, 11, Authorised (updated)
10/05/2019 Template or form: Form for submission of comments on scientific guidelines (updated)
10/05/2019 ICH E8 General considerations for clinical studies (updated)
10/05/2019 Scientific guideline: ICH: E 8 (R1): General considerations for clinical studies - Step 2b
10/05/2019 Medical devices (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Additional monitoring, 8, Authorised (updated)
10/05/2019 Veterinary medicines European public assessment report (EPAR): Loxicom, meloxicam, 10/02/2009, Generic, 14, Authorised (updated)
10/05/2019 Veterinary medicines European public assessment report (EPAR): Eryseng, Erysipelothrix rhusiopathiae, strain R32E11 (inactivated), 04/07/2014, 4, Authorised (updated)
10/05/2019 Herbal medicinal product: Malvae sylvestris flos, Malvae sylvestris flos, F: Assessment finalised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, 20/11/2018, 1, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Pregabalin Accord, pregabalin, Anxiety Disorders, Epilepsy, 28/08/2015, Generic, 6, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 5, Authorised (updated)
10/05/2019 Periodic safety update single assessment: Adapalene: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/0058/201807
10/05/2019 Periodic safety update single assessment: Adapalene: List of nationally authorised medicinal products - PSUSA/0058/201807
10/05/2019 Periodic safety update single assessment: Colchicine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000858/201807
10/05/2019 Human medicines European public assessment report (EPAR): Qtern, Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 15/07/2016, 3, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human, 20/05/2016, Additional monitoring, Conditional approval, 3, Authorised (updated)
10/05/2019 Periodic safety update single assessment: Colchicine: List of nationally authorised medicinal products - PSUSA/00000858/201807
10/05/2019 Report: COMP meeting report on the review of applications for orphan designation: April 2019
10/05/2019 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 24/08/2017, Additional monitoring, Biosimilar, 9, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 18, Authorised (updated)
10/05/2019 Newsletter: Human medicines highlights - May 2019
10/05/2019 Human medicines European public assessment report (EPAR): Zonegran, zonisamide, Epilepsies, Partial, 10/03/2005, 30, Authorised (updated)
10/05/2019 Human medicines European public assessment report (EPAR): Arzerra, ofatumumab, Leukemia, Lymphocytic, Chronic, B-Cell, 19/04/2010, 16, Withdrawn (updated)
10/05/2019 Public Statement: Public statement on Arzerra: Withdrawal of the marketing authorisation in the European Union
10/05/2019 Regulatory and procedural guideline: EudraVigilance release notes v.1.19 (updated)
08/05/2019 Orphan designation: Pegylated proline-interferon alpha-2b (ropeginterferon alfa-2b) for the: Treatment of polycythaemia vera, 09/12/2011, Withdrawn (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 41, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Besremi, ropeginterferon alfa-2b, Polycythemia Vera, 15/02/2019, Additional monitoring, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 11, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Additional monitoring, 3, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Spectrila, asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 3, Authorised (updated)
08/05/2019 Referral: Lemtrada ,  alemtuzumab , Article 20 procedures, Under evaluation, 29/04/2019, 08/05/2019 (updated)
08/05/2019 Periodic safety update single assessment: Montelukast: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002087/201807
08/05/2019 Periodic safety update single assessment: Montelukast: List of nationally authorised medicinal products - PSUSA/00002087/201807
08/05/2019 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 15, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Temozolomide Sun, temozolomide, Glioma, Glioblastoma, 13/07/2011, Generic, 14, Authorised (updated)
08/05/2019 Periodic safety update single assessment: Alprostadil (patency of the ductus arteriosus): List of nationally authorised medicinal products - PSUSA/00010021/201807
08/05/2019 Periodic safety update single assessment: Alprostadil (patency of the ductus arteriosus): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010021/201807
08/05/2019 Human medicines European public assessment report (EPAR): Qutenza, capsaicin, Neuralgia, 15/05/2009, 12, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 29/05/2006, Additional monitoring, Exceptional circumstances, 26, Authorised (updated)
08/05/2019 Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, 06/09/2010, 10, Authorised (updated)