EMA Authorized Product Information Research Net (EMAAPIRN)

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EMA Authorized Product Information Research Net Date of update:2016/10/12

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Aerivio Spiromax salmeterol xinafoate / fluticasone propionate Asthma Pulmonary Disease, Chronic Obstructive 2016-08-18 Teva B.V. Hybiedi application, fixed- dose combination Article 10(3) Inhalation powder Public assessment report
Airexar Spiromax salmeterol / fluticasone propionate Asthma Pulmonary Disease, Chronic Obstructive 2016-08-18 Teva B.V. Hybiedi application, fixed- dose combination Article 10(3) Inhalation powder Public assessment report
Zalmoxis Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) Graft vs Host DiseaseHematopoietic Stem Cell Transplantation 2016-08-18 MolMed SpA Conditional approval, orphan drug New active Substance status Article 8.3 Injection , cell dispersion for infusion Stem cell Public assessment report
Cinqaero reslizumab Asthma 2016-08-16 Teva Pharmaceuticals Limited New active substance Article 8.3 Biologics, a humanized recombinant monoclonal antibody (mAb) Public assessment report
Zepatier elbasvir / grazoprevir Hepatitis C, Chronic 2016-07-22 Merck Sharp & Dohme Limited New active substance status Article 8.3 Film coated tablet Public assessment report
Pemetrexed Fresenius Kabi pemetrexed Carcinoma, Non-Small-Cell Lung Mesothelioma 2016-07-22 Fresenius Kabi Oncology Plc Generic Article 10(1) Injection ,powder for concentrate for solution for infusion
Bortezomib Sun bortezomib Multiple Myeloma 2016-07-22 SUN Pharmaceutical Industries (Europe) B.V. Generic Article 10(1) Injection, powder for solution for injection
Qtern saxagliptin / dapagliflozin propanediol monohydrate Diabetes Mellitus, Type 2 2016-07-15 Astra Zeneca AB Combination Article 10(b) Film coated tablet Public assessment report
EndolucinBeta lutetium (177 Lu) chloride Radionuclide Imaging 2016-07-06 ITG Isotope Technologies Garching GmbH solution of hydrochloric acid Public assessment report
Epclusa sofosbuvir / velpatasvir Hepatitis C, Chronic 2016-07-06 Gilead Sciences International Ltd Film coated tablet Public assessment report
Zinbryta daclizumab Multiple Sclerosis 2016-07-01 Biogen Idec Ltd New active Substance status Article 8.3 1 mL sterile, Type 1 glass pre-filled syringe (PFS). Biologics, monoclonal antibody Public assessment report
Enzepi pancreas powder Exocrine Pancreatic Insufficiency 2016-06-29 Allergan Pharmaceuticals International Ltd Article 8.3 Capsule Public assessment report
Ongentys opicapone Parkinson Disease 2016-06-24 Bial - Portela & C, S.A. New active substance status Article 8.3 Capsule Public assessment report
Zavicefta ceftazidime / avibactam Diseases Gram-Negative Bacterial Infections, Pneumonia, Pneumonia, Bacteria, lSoft Tissue Infections, Urinary Tract Infections 2016-06-24 Astra Zeneca AB New active substance , fixed drug combination (FDC) Article 8.3 Injection, sterile, pyrogen-free, and white to pale yellow powder in 20 mL sterile pyrogen free vials. The Public assessment report
Odefsey emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide HIV Infections 2016-06-21 Gilead Sciences International Ltd New active Substance status Article 8.3 Film coated tablets Public assessment report
Palonosetron Accord palonosetron Cancer, Nausea, Vomiting 2016-05-26 Accord Healthcare Ltd Generics Generics Article 10(1) Injection, solution
Neparvis sacubitril / valsartan Heart Failure 2016-05-26 Novartis Europharm Ltd Combination Article 10? film-coated tablets Public assessment report
Galafold migalastat hydrochloride Fabry Disease 2016-05-26 Amicus Therapeutics UK Ltd Orphan drug New active substance Article 8.3 Tablet Public assessment report
Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells Severe Combined Immunodeficiency 2016-05-26 GlaxoSmithKline Trading Services Limited Orphan drug New active substance Article 8.3 Injection, infusion, suspension gene therapy, autologous genetically modified CD34+ cells Public assessment report
Flixabi infliximab Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn DiseasePsoriasis, Spondylitis, Ankylosing 2016-05-26 Samsung Bioepis UK Limited (SBUK) Biosimilar Article 10(4) Injection , powder for concentrate for solution for infusion Biologics, chimeric human/mouse monoclonal IgG1 antibody Public assessment report
Pandemic influenza vaccine H5N1 MedImmune reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain Influenza, Human 2016-05-20 MedImmune LLC conditional approval New active substance Article 8.3 Nasal spray suspension Biologics, vaccine Fluenz Tetr Public assessment report
Darzalex daratumumab Multiple Myeloma 2016-05-20 Janssen-Cilag International N.V. Orphan drug, conditional approval New active substance Article 8.3 Injectio, liquid concentrate for solution for infusion in a Type I glass vial Biologics. fully human immunoglobulin G1虜 (IgG1虜) monoclonal antibody Public assessment report
Uptravi selexipag Hypertension, Pulmonary 2016-05-12 Actelion Registration Ltd Orphan drug, conditional approval New active substance Article 8.3 Immediate release film-coated tablets Public assessment report
Alprolix eftrenonacog alfa Hemophilia B 2016-05-12 Biogen Idec Ltd Orphan drug New active substance Article 8.3 Injection, powder Biologics, fully recombinant coagulation factor IX Fc fusion protein Public assessment report
Empliciti elotuzumab Multiple Myeloma 2016-05-11 Bristol-Myers Squibb New active substance Article 8.3 Injection, powder for concentrate for solution for infusion Biologics, humanised IgG1 monoclonal antibody Public assessment report
Idelvion albutrepenonacog alfa Hemophilia B 2016-05-11 CSL Behring GmbH Orphan drug New active substance Article 8.3 Injection, a sterile lyophilized powder Biologics, recombinant fusion protein linking recombinant coagulation factor IX (rIX-FP) Public assessment report
Lonsurf trifluridine / tipiracil hydrochloride Colorectal Neoplasms 2016-04-25 Les Laboratoires Servier New active substance Article 8.3 Tablet Public assessment report
Taltz ixekizumab Psoriasis 2016-04-25 Eli Lilly Nederland B.V. New active substance Article 8.3 Injection, subcutaneous administration Biologics, a humanised monoclonal antibody (MAb Public assessment report
Descovy emtricitabine / tenofovir alafenamide HIV Infections 2016-04-21 Gilead Sciences International Ltd Combination New active substance Article 8.3 Film-coated tablet Public assessment report
Palonosetron Hospira palonosetron hydrochloride CancerNauseaVomiting 2016-04-08 Hospira UK Limited Generics Article 10(1) Injection, solution
Rasagiline Mylan rasagiline tartrate Parkinson Disease 2016-04-04 Mylan S.A.S. Generics Article 10(1) Tablet
Wakix pitolisant Narcolepsy 2016-03-31 Bioprojet Pharma Orphan drug Article 8.3 Film-coated tablet Public assessment report
Zonisamide Mylan zonisamide Epilepsy 2016-03-31 Mylan S.A.S. Article 10(1) Hard capsules
Amlodipine / Valsartan Mylan amlodipine besilate / valsartan Hypertension 2016-03-22 Mylan S.A.S Combination Article 10(1) Film-coated tablets
Coagadex human coagulation factor X Factor X Deficiency 2016-03-22 Bio Products Laboratory Limited Orphan drug Article 8.3 Injection, sterile freeze-dried concentrate Biologics, glycoprotein, Blood product Public assessment report
Neofordex dexamethasone Multiple Myeloma 2016-03-22 Laboratoires CTRS Orphan drug Article 10(3) Tablet Public assessment report
Iblias octocog alfa Hemophilia A 2016-02-18 Bayer Pharma AG Article 8.3 Injection, powder and solvent for solution for injection Biologics, recombinant human coagulation factor VIII (rFVIII) Public assessment report
Kovaltry octocog alfa Hemophilia A 2016-02-18 Bayer Pharma AG Article 8.3 Injection, powder and solvent for solution for injection full-length recombinant human coagulation factor VIII (rFVIII) Public assessment report
Zurampic lesinurad Hyperuricemia 2016-02-18 AstraZeneca AB Article 8.3 Film-coated tablet Public assessment report
Portrazza necitumumab Carcinoma, Non-Small-Cell Lung 2016-02-15 Eli Lilly Nederland B.V. Article 8.3 Injection, concentrate for solution for infusion Biologics, recombinant human IgG1 monoclonal antibody Public assessment report
Vaxelis Diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3 / hepatitis B surface antigen produced in yeast cells / poliovirus (inactivated): type 1 (Mahoney), type 2 Diphtheria, Hepatitis B, Meningitis, Haemophilus, Poliomyelitis, Tetanus, Whooping Cough 2016-02-15 Sanofi Pasteur MSD SNC Article 8.3 Injection, intramuscular injection, suspension for injection Vaccine Public assessment report
Tagrisso osimertinib mesylate Carcinoma, Non-Small-Cell Lung 2016-02-02 AstraZeneca AB Conditional Approval Article 8.3 Film-coated tablets Public assessment report
Armisarte (previously Pemetrexed Actavis) pemetrexed diacid monohydrate Carcinoma, Non-Small-Cell Lung, Mesothelioma 2016-01-18 Actavis Group PTC ehf Article 10(3) Injection, concentrate for solution for infusion Public assessment report
Pemetrexed Accord pemetrexed disodium hemipentahydrate Carcinoma, Non-Small-Cell Lung, Mesothelioma 2016-01-18 Accord Healthcare Ltd Article 10(1) Injection, concentrate for solution for infusion
Benepali etanercept Arthritis, Psoriatic Arthritis, Rheumatoid Psoriasis 2016-01-14 Samsung Bioepis UK Limited (SBUK) Article 10(4) Injection, single-use pre-filled syringes and pre-filled pens Bilologics, chimeric protein Public assessment report
Briviact brivaracetam Epilepsy 2016-01-14 UCB Pharma SA Article 8.3 Film-coated tablet; oral solution ; a solution for injection/infusion Public assessment report
Episalvan betulae cortex dry extract? (5-10 : 1); extraction solvent: n-heptane 95% (w/w) Wound Healing, Wounds and Injuries 2016-01-14 Birken AG Article 8.3 Sterile gel Public assessment report
Lopinavir/Ritonavir Mylan lopinavir/ritonavir HIV Infections 2016-01-14 MYLAN S.A.S. Generic Article 10(1) film-coated tablets
Oncaspar pegaspargase Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14 Baxalta Innovations GmbH Article 8.3 Injection, injection or infusion is a sterile enzyme Public assessment report
Spectrila asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14 Medac Gesellschaft fuer klinische Spezialpraeparate mbH Article 8.3 Injection, a sterile, lyophilised powder for concentrate for solution for infusion recombinant L-asparaginase Public assessment report
Eptifibatide Accord eptifibatide Myocardial Infarction 2016-01-11 Accord Healthcare Limited Article 10(1) Injection, Solution for infusion
Nucala mepolizumab Asthma 2015-12-02 GlaxoSmithKline Trading Services New active substance Article 8(3) Sterile lyophilised white powder for solution for injection in Type I clear glass vial Biologics, recombinant humanised monoclonal IgG (IgG1 kappa) antibody Public assessment report
Ravicti ?glycerol phenylbutyrate Urea Cycle Disorders, Inborn 2015-11-27 Horizon Therapeutics Limited Orphan drug New active substance Article 8(3) Oral liquid Public assessment report
Blincyto blinatumomab Precursor Cell Lymphoblastic Leukemia-Lymphoma 2015-11-23 Amgen Europe B.V. Orphan drug , conditional approval New active substance Article 8(3) Powder for concentrate and solution for solution for infusion. lyophilized formulation Monoclonal antibody Public assessment report
Cotellic cobimetinib hemifumarate Melanoma 2015-11-20 Roche Registration Ltd New active substance Article 8(3) Immediate-release film-coated tablet Public assessment report
Kolbam cholic acid Metabolism, Inborn Errors 2015-11-20 Retrophin Europe Ltd Orphan drug , exceptional circumstances New active substance Article 8(3) Hard gelatine capsules Public assessment report
Pemetrexed Hospira pemetrexed Carcinoma, Non-Small-Cell LungMesothelioma 2015-11-20 Hospira UK Limited Generics Article 10(1) Injection,powder for concentrate for solution for infusion
Praxbind idarucizumab Hemorrhage 2015-11-20 powder for concentrate for solution for infusion New active substance Article 8(3) Biologics, Monoclonal antibody Public assessment report
Cinacalcet Mylan cinacalcet hydrochloride HypercalcemiaHyperparathyroidism, Secondary 2015-11-19 Mylan S.A.S. Generics Article 10(1) Film-coated tablets
Elocta efmoroctocog alfa Hemophilia A 2015-11-19 Biogen Idec Ltd Orphan drug New active substance Article 8(3) Injection, preservative-free, lyophilized, white to off-white powder Biologics, recombinant human coagulation factor VIII Public assessment report
Entresto sacubitril / valsartan Heart Failure 2015-11-19 Novartis Europharm Ltd New active substance Article 8(3) Fixed-dose combination product presented as film-coated tablet Public assessment report
Genvoya elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide HIV Infections 2015-11-19 Gilead Sciences International Ltd New active substance Article 8(3) film-coated tablet Public assessment report
Ionsys fentanyl hydrochloride Pain, Postoperative 2015-11-19 Incline Therapeutics Europe Ltd New active substance Article 8(3) Transdermal system Public assessment report
Kyprolis carfilzomib Multiple Myeloma 2015-11-19 Amgen Europe B.V. New active substance Article 8(3) sterile lyophilized powder for solution for infusion Public assessment report
Numient levodopa / carbidopa Parkinson Disease 2015-11-19 Impax Laboratories (Netherlands) BV New active substance Article 8(3) modified release hard capsules containing levodopa and carbidopa as active substances in a fixed dose combination. Public assessment report
Orkambi lumacaftor / ivacaftor Cystic Fibrosis 2015-11-19 Vertex Pharmaceuticals (Europe) Ltd New active substance Article 8(3) Film-coated tablets Public assessment report
Aripiprazole Accord aripiprazole Bipolar DisorderSchizophrenia 2015-11-16 Accord Healthcare Ltd Generics Article 10(1) Tablet
Ebymect dapagliflozin propanediol monohydrate / metformin hydrochloride Diabetes Mellitus, Type 2 2015-11-16 AstraZeneca AB Article 10(c) Film-coated tablet (tablet Public assessment report
Obizur susoctocog alfa Hemophilia A 2015-11-11 Baxalta Innovations GmbH Exceptional circumstances New active substance Article 8(3) Injection, powder in single-use vials Biologics, purified glycoprotein Public assessment report
Edistride dapagliflozin propanediol monohydrate Diabetes Mellitus, Type 2 2015-11-09 AstraZeneca AB Article 10? Film-coated tablet Public assessment report
Cresemba isavuconazole Aspergillosis 2015-10-15 Basilea Medical Ltd New active substance Article 8(3) Powder for concentrate for solution for infusion Public assessment report
Fexeric ferric citrate coordination complex HyperphosphatemiaRenal Dialysis 2015-09-23 Keryx Biopharma UK Ltd New active substance status Article 8(3) Film-coated tablet Public assessment report
Praluent alirocumab Dyslipidemias 2015-09-23 sanofi-aventis groupe New active substance status Article 8(3) Injection, 1 mL prefilled pen (PFP), or a 1 mL prefilled syringe (PFS) Biologics, fully human monoclonal antibody Public assessment report
Zerbaxa ceftolozane sulfate / tazobactam sodium Bacterial Infections 2015-09-18 Merck Sharp & Dohme Limited New active substance status Article 8(3) Injection, powder for concentrate for solution for infusion Public assessment report
Pemetrexed Sandoz pemetrexed disodium hemipentahydrate Carcinoma, Non-Small-Cell LungMesothelioma 2015-09-18 Sandoz GmbH Generic Powder for concentrate for solution for infusion. White to off-white or pale yellow lyophilised powder.
Zalviso sufentanil Pain, Postoperative 2015-09-18 Grunenthal GmbH Hybrid Article 10(3) Sublingual tablet. Public assessment report
Intuniv guanfacine hydrochloride Attention Deficit Disorder with Hyperactivity 2015-09-17 Shire Pharmaceuticals Ireland Ltd New active substance status Article 8(3) Prolonged-release tablet Public assessment report
Pemetrexed Lilly pemetrexed Carcinoma, Non-Small-Cell LungMesothelioma 2015-09-14 Eli Lilly Netherlands Generics Article 10(1)
Ivabradine Anpharm ivabradine Angina Pectoris 2015-09-08 "Anpharm" Przedsi?biorstwo Farmaceutyczne S.A. Article 10(c) Film-coated tablet Public assessment report
Raxone idebenone Optic Atrophy, Hereditary, Leber 2015-09-08 Santhera Pharmaceuticals (Deutschland) GmbH Orphan drug, exceptional circumstances Hybrid Article 10(3) Immediate release film-coated tablet Public assessment report
Docetaxel Hospira UK Limited docetaxel Breast NeoplasmsCarcinoma, Non-Small-Cell LungHead and Neck NeoplasmsProstatic NeoplasmsStomach Neoplasms 2015-08-28 Generic
Farydak panobinostat lactate anhydrous Multiple Myeloma 2015-08-28 Novartis Europharm Ltd Orphan drug New active substance Article 8(3) Hard capsule (capsule). Product information Public assessment report
Kanuma sebelipase alfa Lipid Metabolism, Inborn Errors 2015-08-28 Synageva BioPharma Ltd Orphan drug New active substance Article 8(3) Concentrate for solution for infusion (sterile concentrate). Product information Public assessment report
Pregabalin Accord pregabalin Anxiety DisordersEpilepsyNeuralgia 2015-08-28 Alexion Europe SAS Orphan drug, exceptional circumstances Generic
Strensiq asfotase alfa Hypophosphatasia 2015-08-28 Alexion Europe SAS exceptional circumstances, orphan drug New active substance Article 8(3) Solution for injection (injection). Product information Public assessment report
Aripiprazole Sandoz aripiprazole Bipolar DisorderSchizophrenia 2015-08-20 Sandoz GmbH Generic
Duloxetine Zentiva duloxetine Anxiety DisordersDepressive Disorder, MajorDiabetes MellitusNeuralgia 2015-08-20 Zentiva, k.s. Generic
Respreeza human alpha1-proteinase inhibitor Genetic Diseases, InbornLung Diseases 2015-08-20 CSL Behring GmbH Article 8(3) Powder and solvent for solution for infusion Biologics, blood Product information Public assessment report
Odomzo sonidegib diphosphate Carcinoma, Basal Cell 2015-08-14 Novartis Europharm Ltd New active substance Article 8(3) Hard capsule (capsule). Product information Public assessment report
Unituxin dinutuximab Neuroblastoma 2015-08-14 United Therapeutics Europe Ltd Orphan drug New active substance Article 8(3) Concentrate for solution for infusion (sterile concentrate). Biologics, monoclonal antibody Product information Public assessment report
Raxone idebenone Optic Atrophy, Hereditary, Leber 2015-08-09 Santhera Pharmaceuticals (Deutschland) GmbH exceptional circumstances, orphan drug Hybrid Application (Article 10(3) Film-coated tablet Product information Public assessment report
Omidria ketorolac / phenylephrine Lens Implantation, IntraocularPain, Postoperative 2015-07-28 Omeros London Limited Article8(3) Concentrate for solution for intraocular irrigation Product information Public assessment report
Bortezomib Accord bortezomib Multiple Myeloma 2015-07-20 Accord Healthcare Ltd Generic Article 10(1)
Nivolumab BMS nivolumab Carcinoma, Non-Small-Cell Lung 2015-07-20 Bristol-Myers Squibb Pharma EEIG New active substance Article8(3) Injection , Concentrate for solution for infusion (sterile concentrate). Biologics, monoclonal antibody Product information Public assessment report
Keytruda pembrolizumab Melanoma 2015-07-17 Merck Sharp & Dohme Limited New active substance Article8(3) Powder for concentrate for solution for infusion Biologics, monoclonal antibody Product information Public assessment report
Pregabalin Zentiva pregabalin Anxiety DisordersEpilepsy 2015-07-17 Generic Article 10(1)
Repatha evolocumab DyslipidemiasHypercholesterolemia 2015-07-17 Amgen Europe B.V. Article 8(3) Solution for injection (injection). Biologics, monoclonal antibody Product information Public assessment report
Evotaz atazanavir sulfate / cobicistat HIV Infections 2015-07-13 Bristol-Myers Squibb Pharma EEIG Article 10(b),Combination Each film-coated Product information Public assessment report
Hetlioz tasimelteon Sleep Disorders, Circadian Rhythm 2015-07-03 Vanda Pharmaceuticals Ltd Orphan drug New active substance Article 8(3) Hard capsule Product information Public assessment report
Aripiprazole Pharmathen aripiprazole Bipolar DisorderSchizophrenia 2015-06-30 Pharmathen S.A. Generic Article 10(1) Authorised

 

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