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22/01/2020 Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 27/11/1995, 46, Authorised (updated)
22/01/2020 Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira, zoledronic acid monohydrate, Hypercalcemia, 19/11/2012, Generic, 16, Authorised (updated)
22/01/2020 Orphan designation: lonapegsomatropin for the: Treatment of growth hormone deficiency, 17/10/2019, Positive
22/01/2020 Periodic safety update single assessment: Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905
22/01/2020 Orphan designation: leriglitazone for the: Treatment of Friedreich’s ataxia, 17/10/2019, Positive
22/01/2020 Veterinary medicines European public assessment report (EPAR): Nobilis IB 4-91, live attenuated avian infectious bronchitis virus variant strain 4-91, 09/06/1998, 14, Authorised (updated)
22/01/2020 Orphan designation: besilesomab for the: Treatment in haematopoietic stem cell transplantation, 17/10/2019, Positive
22/01/2020 Human medicines European public assessment report (EPAR): Darunavir Krka d.d., darunavir, HIV Infections, 18/01/2018, Generic, 4, Authorised (updated)
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of primary biliary cirrhosis, 16/01/2014, Positive (updated)
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of Alagille syndrome, 16/01/2014, Positive (updated)
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of primary sclerosing cholangitis, 16/01/2014, Positive (updated)
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of progressive familial intrahepatic cholestasis, 16/01/2014, Positive (updated)
22/01/2020 Standard Operating Procedure - SOP: Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) (updated)
22/01/2020 Template or form: Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) - Forms 1-7
22/01/2020 Q&A: Type II variations (updated)
22/01/2020 Human medicines European public assessment report (EPAR): Plavix, clopidogrel hydrogen sulfate, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 15/07/1998, 41, Authorised (updated)
22/01/2020 Type-IB variations: questions and answers (updated)
22/01/2020 Type-IA variations: questions and answers (updated)
22/01/2020 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, Additional monitoring, 11, Authorised (updated)
22/01/2020 Human medicines European public assessment report (EPAR): Atriance, nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, 22/08/2007, Orphan, Additional monitoring, Exceptional circumstances, 22, Authorised (updated)
22/01/2020 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, Orphan, 13, Authorised (updated)
22/01/2020 Orphan designation: Autologous CD34+ haematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene for the: Treatment of beta-thalassaemia intermedia and major, 17/10/2019, Positive
22/01/2020 Orphan designation: Anti-neonatal Fc receptor human monoclonal antibody for the: Prevention of haemolytic disease of the foetus and newborn, 17/10/2019, Positive
22/01/2020 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 27, Authorised (updated)
22/01/2020 Orphan designation: Combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- half coding sequences of human ABCA4 fused to inteins for the: Treatment of Stargardt's disease, 17/10/2019, Positive
21/01/2020 Orphan designation: 4-oxo-4H-chromene-2-carboxylic acid (2-(2-4-(2-(6,7-dimethoxy-3,4-dihydro-1H-isoquinolin-2-yl)-ethyl)-phenyl-2H-tetrazol-5-yl)-4,5-dimethoxy-phenyl)-amide for the: Treatment of soft tissue sarcoma, 17/10/2019, Positive
21/01/2020 Orphan designation: 2'-O-(2-methoxyethyl)-D-ribose antisense oligonucleotide targeting glial fibrillary acidic protein messenger ribonucleic acid for the: Treatment of Alexander disease, 17/10/2019, Positive
21/01/2020 Veterinary medicines European public assessment report (EPAR): Neocolipor, E. coli F6 / E. coli field strain ag f41 / Recombinant e.coli ag k88 (or f4) (ab, ac, ad) / Recombinant e.coli ag k99 (or f5), 14/04/1998, 11, Authorised (updated)
21/01/2020 Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt for the: Treatment of graft-versus-host disease, 17/10/2019, Positive
21/01/2020 Orphan designation: 18-(p-(131I)-iodophenyl)octadecyl phosphocholine for the: Treatment of multiple myeloma, 17/10/2019, Positive
21/01/2020 Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, Additional monitoring, Conditional approval, 2, Authorised (updated)
21/01/2020 Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} for the: Treatment of Netherton syndrome, 17/10/2019, Positive
21/01/2020 Referrals document: Picato Article-20 referral - Annex I
21/01/2020 Referrals document: Picato Article-20 referral - Assessment report on provisional measures
21/01/2020 Referral: Picato , ingenol mebutate , Article 20 procedures, Under evaluation, 21/01/2020 (updated)
21/01/2020 Orphan designation: (16E)-14-methyl-20-oxa-5,7,14,26-tetraaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene–citric acid for the: Treatment of glioma, 17/10/2019, Positive
21/01/2020 Other: Privacy Statement for the EMA individual experts’ stakeholder database
21/01/2020 Other: Privacy Statement concerning Public Hearings at the European Medicines Agency
21/01/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 6, Authorised (updated)
21/01/2020 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors (updated)
21/01/2020 Other: Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors (updated)
21/01/2020 Other: European Medicines Agency’s Privacy Statement: Small and Medium Enterprises (SME) Office activities
21/01/2020 Regulatory and procedural guideline: EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1
21/01/2020 Agenda: Agenda - CVMP agenda of the 21-23 January 2020 meeting
21/01/2020 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, Additional monitoring, 4, Authorised (updated)
21/01/2020 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 26, Authorised (updated)
21/01/2020 Human medicines European public assessment report (EPAR): Movymia, teriparatide, Osteoporosis, 11/01/2017, Additional monitoring, Biosimilar, 6, Authorised (updated)
21/01/2020 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 20, Authorised (updated)
21/01/2020 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, 9, Authorised (updated)
20/01/2020 Orphan designation: nilotinib for the: Treatment of chronic myeloid leukaemia, 22/05/2006, Expired (updated)
20/01/2020 Human medicines European public assessment report (EPAR): Zavicefta, Ceftazidime, avibactam, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections, 23/06/2016, Additional monitoring, 8, Authorised (updated)
20/01/2020 Human medicines European public assessment report (EPAR): Vargatef, nintedanib, Carcinoma, Non-Small-Cell Lung, 21/11/2014, 12, Authorised (updated)
20/01/2020 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Orphan, Accelerated assessment, 12, Authorised (updated)
20/01/2020 Human medicines European public assessment report (EPAR): Kengrexal, cangrelor, Acute Coronary Syndrome, Vascular Surgical Procedures, 23/03/2015, Additional monitoring, 8, Authorised (updated)
20/01/2020 Referral: Flurbiprofen Geiser , flurbiprofen , Flurbiprofen Sejmet,Mentocaína Spray,Flurbiprofeno Geiser, Article 29(4) referrals, European Commission final decision, 17/10/2019, 16/12/2019, 20/01/2020 (updated)
20/01/2020 Periodic safety update single assessment: Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905
20/01/2020 Periodic safety update single assessment: Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905
20/01/2020 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 11, Authorised (updated)
20/01/2020 Scientific guideline: Reflection paper on good manufacturing practice and marketing authorisation holders
20/01/2020 Other: Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency
20/01/2020 Eligible healthcare professionals' organisations (updated)
20/01/2020 Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, 28/03/2019, Additional monitoring, 1, Authorised (updated)
20/01/2020 Periodic safety update single assessment: Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812
20/01/2020 News and press releases: Ten recommendations to unlock the potential of big data for public health in the EU
20/01/2020 Big data (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 31, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Tovanor Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 13, Authorised (updated)
17/01/2020 Other: Article 57 product data (updated)
17/01/2020 Report: Applications for new human medicines under evaluation by the CHMP: January 2020
17/01/2020 Newsletter: Human medicines highlights - January 2020
17/01/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020
17/01/2020 News and press releases: EMA suspends Picato as a precaution while review of skin cancer risk continues
17/01/2020 News and press releases: PRAC confirms four-week limit for use of high-strength estradiol creams
17/01/2020 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 11, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism, 30/09/2008, Additional monitoring, 32, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, 17, Authorised (updated)
17/01/2020 Periodic safety update single assessment: Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905
17/01/2020 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 4, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, Additional monitoring, 6, Authorised (updated)
17/01/2020 Veterinary medicines European public assessment report (EPAR): Imrestor, Pegbovigrastim, 09/12/2015, 2, Authorised (updated)
17/01/2020 Veterinary medicines European public assessment report (EPAR): Vaxxitek HVT+IBD, Recombinant turkey herpesvirus, strain vhvt013-69, live, 09/08/2002, 11, Authorised (updated)
17/01/2020 Veterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, 16/12/2008, 12, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, 06/09/2010, 11, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir 90 mg, sofosbuvir 400 mg, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 19, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes, 14/06/2007, Additional monitoring, 39, Authorised (updated)
17/01/2020 Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesylate, Melanoma, 26/08/2013, 21, Authorised (updated)
16/01/2020 Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for the: Treatment of peripheral T-cell lymphoma, 21/09/2019, Positive (updated)
16/01/2020 Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for the: Treatment of C3 glomerulopathy, 21/08/2019, Positive
16/01/2020 Orphan designation: Overview (updated)
16/01/2020 Changing the name or address of a sponsor (updated)
16/01/2020 Orphan designation: Adenoviral vector serotype 5 encoding the human interleukin-12 p70 transgene under the control of activator ligand veledimex for the: Treatment of glioma, 21/08/2019, Positive
16/01/2020 Orphan designation: Veledimex for the: Treatment of glioma, 21/08/2019, Positive
16/01/2020 Orphan designation: Clofazimine for the: Treatment of nontuberculous mycobacterial lung disease, 21/08/2019, Positive
16/01/2020 Applying for orphan designation (updated)
16/01/2020 Human medicines European public assessment report (EPAR): Bortezomib Hospira, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 8, Authorised (updated)
16/01/2020 Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia, 09/06/2015, Additional monitoring, 12, Authorised (updated)
16/01/2020 Other: Extension of reserve lists for external selection procedures: Temporary Agent reserve lists (updated)
16/01/2020 Removing an orphan designation (updated)
16/01/2020 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 16/01/2020 (updated)
16/01/2020 Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN6 gene for the: Treatment of neuronal ceroid lipofuscinosis, 21/08/2019, Positive
16/01/2020 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 4, Authorised (updated)
16/01/2020 Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene for the: Treatment of neuronal ceroid lipofuscinosis, 21/08/2019, Positive
16/01/2020 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 13, Authorised (updated)
16/01/2020 Orphan designation: 1-(2,2-diphenyltetrahydrofuran-3-yl)-N,N-dimethylmethanamine hydrochloride for the: Treatment of Rett syndrome, 21/08/2019, Positive
16/01/2020 Orphan designation: Herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes for the: Adjunctive treatment in haematopoietic cell transplantation, 20/10/2003, Withdrawn (updated)
16/01/2020 Orphan designation: Triheptanoin for the: Treatment of glucose transporter type-1 deficiency syndrome, 21/05/2015, Withdrawn (updated)
16/01/2020 Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile for the: Treatment of medullary thyroid carcinoma, 26/10/2018, Withdrawn (updated)
16/01/2020 News and press releases: EMA welcomes new Head of Information Management Division
16/01/2020 Executive Director (updated)
16/01/2020 Information Management (updated)
16/01/2020 Other: Organisation chart: Information Management (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Roteas, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/04/2017, Additional monitoring, 4, Authorised (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 18, Authorised (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 20, Authorised (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Aerivio Spiromax, salmeterol xinafoate, fluticasone propionate, Pulmonary Disease, Chronic Obstructive, Asthma, 18/08/2016, 2, Withdrawn (updated)
15/01/2020 Leaflet: Responsible use of antibiotics protects animals and people - 2011-2017 Sales of antibiotics for veterinary use are down - Infographic (updated)
15/01/2020 Committee for Advanced Therapies (CAT): 11-13 September 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2019 to 13/09/2019 (updated)
15/01/2020 Minutes: Minutes of the CAT meeting 11-13 September 2019
15/01/2020 Paediatric Committee (PDCO): 12-15 November 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 12/11/2019 to 15/11/2019 (updated)
15/01/2020 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 12-15 November 2019
15/01/2020 Committee for Herbal Medicinal Products (HMPC): 13-15 January 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 13/01/2020 to 15/01/2020 (updated)
15/01/2020 Agenda: Agenda - HMPC agenda of the 13-15 January 2020 meeting
15/01/2020 Veterinary medicines European public assessment report (EPAR): Zactran, gamithromycin, 24/07/2008, 11, Authorised (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics), tadalafil, Hypertension, Pulmonary, 09/01/2017, Generic, 4, Authorised (updated)
15/01/2020 Human medicines European public assessment report (EPAR): Infanrix Hexa, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type-b polysaccharide, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 23/10/2000, 41, Authorised (updated)
15/01/2020 Orphan designation: Olaratumab for the: Treatment of soft tissue sarcoma, 12/02/2015, Withdrawn (updated)
15/01/2020 EudraVigilance (updated)
15/01/2020 News and press releases: Mandatory use of international standard for the reporting of side effects to improve safety of medicines
15/01/2020 Other: Announcement of the EMA Management Board - Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology
14/01/2020 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 11/11/2012, 17, Authorised (updated)
14/01/2020 Veterinary medicines European public assessment report (EPAR): ProZinc, insulin human, 12/07/2013, 9, Authorised (updated)
14/01/2020 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 25, Authorised (updated)
14/01/2020 Orphan designation: 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-(2-propynyl)-1,3-thiazol-2-amine for the: Treatment of congenital adrenal hyperplasia, 21/08/2019, Positive
14/01/2020 Periodic safety update single assessment: Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902
14/01/2020 Periodic safety update single assessment: Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902
14/01/2020 Orphan designation: acetazolamide for the: Treatment of periodic paralysis, 21/08/2019, Positive
14/01/2020 Other: Extension of reserve lists for external selection procedures: Contract Agent reserve list (updated)
14/01/2020 Periodic safety update single assessment: Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903
14/01/2020 Periodic safety update single assessment: Erythromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001257/201903
14/01/2020 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 30, Authorised (updated)
14/01/2020 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration, Macular Edema, Myopia, Degenerative, Diabetes Complications, 22/01/2007, 36, Authorised (updated)
14/01/2020 Orphan designation: Relacorilant for the: Treatment of pancreatic cancer, 21/08/2019, Positive
14/01/2020 Orphan designation: Setmelanotide for the: Treatment of Bardet-Biedl syndrome, 21/08/2019, Positive
14/01/2020 Orphan designation: Peginterferon lambda-1a for the: Treatment of hepatitis D virus infection, 21/08/2019, Positive
14/01/2020 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 4, Authorised (updated)
14/01/2020 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
14/01/2020 Orphan designation: gallium citrate for the: Treatment of cystic fibrosis, 21/08/2019, Positive
14/01/2020 Orphan designation: temozolomide for the: Treatment of neuroblastoma, 21/08/2019, Positive
14/01/2020 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised (updated)
14/01/2020 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 22, Authorised (updated)
14/01/2020 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 3, Authorised (updated)
13/01/2020 Agenda: Agenda - PRAC draft agenda of meeting 13-16 January 2020
13/01/2020 Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
13/01/2020 Orphan designation: lenalidomide for the: Treatment of marginal zone lymphoma, 24/04/2015, Withdrawn (updated)
13/01/2020 Orphan designation: lenalidomide for the: Treatment of diffuse large B-cell lymphoma, 13/05/2011, Withdrawn (updated)
13/01/2020 Orphan designation: lenalidomide for the: Treatment of chronic lymphocytic leukaemia, 19/11/2007, Withdrawn (updated)
13/01/2020 Orphan designation: lenalidomide for the: Treatment of mantle cell lymphoma, 27/10/2011, Withdrawn (updated)
13/01/2020 Orphan designation: "3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione (lenalidomide) for the: Treatment of myelodysplastic syndromes, 08/03/2004, Withdrawn (updated)
13/01/2020 Orphan designation: lenalidomide for the: Treatment of follicular lymphoma, 24/01/2013, Withdrawn (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, 17, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus, 20/08/2015, Generic, 5, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis, 15/06/2017, Additional monitoring, Biosimilar, 4, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic, 08/06/2001, 42, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Breast Neoplasms, 09/03/2004, 21, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Additional monitoring, Biosimilar, 8, Authorised (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 18/08/2016, 10, Authorised (updated)
13/01/2020 Orphan designation: Two allogeneic irradiated pancreatic tumour cell lines for the: Treatment of pancreatic cancer, 11/01/2016, Withdrawn (updated)
13/01/2020 Orphan designation: Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin for the: Treatment of pancreatic cancer, 11/01/2016, Withdrawn (updated)
13/01/2020 Orphan designation: Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin for the: Treatment of malignant mesothelioma, 14/12/2015, Withdrawn (updated)
13/01/2020 Orphan designation: Ulocuplumab for the: Treatment of acute myeloid leukaemia, 12/02/2015, Withdrawn (updated)
13/01/2020 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for the treatment of sickle cell disease for the: The treatment of sickle cell disease, 29/04/2014, Positive (updated)
13/01/2020 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 1, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 08/09/2003, 75, Authorised (updated)
10/01/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 10, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 14/07/1998, 41, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Zydelig, Idelalisib, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 18/09/2014, Additional monitoring, 16, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 8, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Kuvan, Sapropterin dihydrochloride, Phenylketonurias, 02/12/2008, Orphan, 19, Authorised (updated)
10/01/2020 Periodic safety update single assessment: Ezetimibe / simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001347/201903
10/01/2020 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome, Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 1, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Ketoconazole HRA, Ketoconazole, Cushing Syndrome, 18/11/2014, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
10/01/2020 Regulatory and procedural guideline: IRIS guide for Parallel Distribution applicants (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Trumenba, Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal, 24/05/2017, Additional monitoring, 6, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, 13/11/2013, Patient safety, Additional monitoring, 10, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Xiapex, collagenase Clostridium histolyticum, Dupuytren Contracture, 28/02/2011, 20, Authorised (updated)
10/01/2020 Periodic safety update single assessment: Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903
10/01/2020 Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 14, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 17, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 13, Authorised (updated)
10/01/2020 Other: Privacy Statement regarding the Experts database and the handling of competing interests of scientific committees’ members and experts
10/01/2020 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 14, Authorised (updated)
10/01/2020 Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Fabry Disease, 03/08/2001, Orphan, 27, Authorised (updated)
10/01/2020 Medicine evaluation figures (updated)
10/01/2020 News and press releases: Veterinary medicines: highlights of 2019
10/01/2020 Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 28/06/2017, Orphan, Additional monitoring, 6, Authorised (updated)
10/01/2020 Report: Veterinary medicines highlights 2019
09/01/2020 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 16, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 15, Authorised (updated)
09/01/2020 Veterinary medicines European public assessment report (EPAR): Broadline, eprinomectin, fipronil, praziquantel, (S)-methoprene, 04/12/2013, 9, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 09/09/2013, Biosimilar, 24, Authorised (updated)
09/01/2020 Minutes: Minutes of the COMP meeting 10-12 September 2019
09/01/2020 News and press releases: Human medicines: highlights of 2019
09/01/2020 Report: Human medicines highlights 2019
09/01/2020 Veterinary medicines European public assessment report (EPAR): Purevax RC, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), 23/02/2005, 11, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 07/06/2010, Biosimilar, 21, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, 26/07/2018, Generic, 1, Authorised (updated)
09/01/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 12, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Additional monitoring, Biosimilar, 12, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Seebri Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 9, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Shingrix, Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster, 21/03/2018, Additional monitoring, 3, Authorised (updated)
09/01/2020 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular, Pain, Postoperative, 28/07/2015, 4, Authorised (updated)
09/01/2020 Veterinary medicines European public assessment report (EPAR): Neptra, florfenicol, Terbinafine hydrochloride, Mometasone furoate, 10/12/2019, Authorised
09/01/2020 Frequently asked questions about parallel distribution (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Pregabalin Accord, pregabalin, Anxiety Disorders, Epilepsy, 28/08/2015, Generic, 7, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hcl, Soft Tissue Infections, Skin Diseases, Bacterial, 19/02/2015, 9, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 13, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Osteoporosis, Postmenopausal, 17/04/2009, 13, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections, Skin Diseases, Bacterial, Soft Tissue Infections, 24/04/2006, 30, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia, Arthritis, Gouty, Gout, 15/06/2017, Generic, 3, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 7, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity, Overweight, 23/03/2015, Additional monitoring, 8, Authorised (updated)
08/01/2020 Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 20, Authorised (updated)
08/01/2020 Veterinary medicines European public assessment report (EPAR): Mirataz, mirtazapine, 10/12/2019, Authorised
08/01/2020 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 28/04/2017, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
08/01/2020 Regulatory and procedural guideline: IRIS guide to registration (updated)
08/01/2020 Regulatory and procedural guideline: IRIS guide for applicants (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 4, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 11, Authorised (updated)
07/01/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
07/01/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 25-28 November 2019 PRAC meeting
07/01/2020 Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, Orphan, Accelerated assessment, Additional monitoring, 15, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 12, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 46, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 34, Authorised (updated)
07/01/2020 Other: Questions and answers on impact of European Union-United States mutual recognition agreement on marketing authorisation applications and relevant variations (updated)
07/01/2020 Human medicines European public assessment report (EPAR): TachoSil, human fibrinogen, human thrombin, Hemostasis, Surgical, 08/06/2004, 23, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Qtern, Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 15/07/2016, 4, Authorised (updated)
07/01/2020 Eligible patients and consumers organisations (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 9, Authorised (updated)
07/01/2020 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 7, Authorised (updated)
06/01/2020 Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, 19/01/2015, Orphan, Additional monitoring, 11, Authorised (updated)
06/01/2020 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors, Radionuclide Imaging, 08/12/2016, Orphan, Additional monitoring, 4, Authorised (updated)
06/01/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 10, Authorised (updated)
06/01/2020 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 9, Authorised (updated)
06/01/2020 EPAR - Procedural steps taken and scientific information after authorisation: SomaKit TOC : EPAR - Procedural steps taken and scientific information after authorisation (updated)
06/01/2020 Veterinary medicines European public assessment report (EPAR): Previcox, firocoxib, 13/09/2004, 22, Authorised (updated)
06/01/2020 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, Additional monitoring, 1, Authorised (updated)
06/01/2020 Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 22, Authorised (updated)
06/01/2020 Orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein for the: Treatment of Ebola virus disease, 25/05/2018, Positive (updated)
06/01/2020 Orphan designation: Tipifarnib for the: Treatment of acute myeloid leukaemia, 10/03/2005, Positive (updated)