Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
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1 7 January 2016 EMA/6499/2016 Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use January 2016 This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. This list only includes information for medicines whose applications have been validated at the time the report was compiled. The information in this report was compiled on 5 January Information on designated orphan medicines that are being assessed for marketing authorisation is also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP). Information in bold corresponds to new entries in the monthly list. Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website. Information on CHMP opinions is also published in the monthly CHMP highlights. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Non-orphan medicinal products International non-proprietary name (salt, ester, derivative, etc.) / Common Name Abaloparatide Alectinib (hydrochloride) Anamorelin (hydrochloride) Bezlotoxumab Brodalumab Ceftazidime / avibactam Daclizumab Dasabuvir (sodium) / ombitasvir / paritaprevir / ritonavir Dimethyl fumarate Eluxadoline Empagliflozin / linagliptin Emtricitabine / rilpivirine (hydrochloride) / tenofovir alafenamide (fumarate) Emtricitabine / tenofovir alafenamide Etelcalcetide (hydrochloride) Fluciclovine (18F) Follitropin delta Glycopyrronium bromide Grazoprevir / elbasvir Iloperidone Insulin aspart Ixekizumab Lonoctocog alfa Lutetium (177 Lu) chloride Opicapone Palbociclib Pancreas powder Therapeutic area 1 Other therapeutic medicines Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Antibacterials for systemic use Antipsoriatics Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Diagnostic radiopharmaceuticals Sex hormones and modulators of the genital system Medicines for functional gastrointestinal disorders Psycholeptics Therapeutic radiopharmaceuticals Anti-parkinson medicines Digestives, incl. enzymes 1 Based on the ATC therapeutic sub-group. EMA/6499/2016 Page 2/5
3 International non-proprietary name (salt, ester, derivative, etc.) / Common Name Pandemic influenza vaccine H5N1 (live attenuated, nasal) Reslizumab Rociletinib (hydrobromide) Saxagliptin / dapagliflozin (propanediol monohydrate) Sodium zirconium cyclosilicate Sofosbuvir / velpatasvir Spheroids of human autologous matrixassociated chondrocytes Trifluridine / tipiracil (hydrochloride) Therapeutic area 1 Vaccines Other therapeutic medicines Other medicines for disorders of the musculo-skeletal system Non-orphan generic and biosimilar medicinal products International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Adalimumab 2 Alendronic acid / colecalciferol Medicines for bone diseases 1 Amlodipine / valsartan Medicines acting on the reninangiotensin 1 system Aripiprazole Psycholeptics 1 Atazanavir 1 Bortezomib 2 Darunavir 1 Docetaxel 1 Emtricitabine / tenofovir disoproxil 3 Enoxaparin sodium Antithrombotic medicines 2 Ertapenem Antibacterials for systemic use 1 Etanercept 1 Fluticasone / salmeterol Medicines for obstructive airway 2 diseases Infliximab 1 Insulin glargine 1 2 Based on the ATC therapeutic sub-group. EMA/6499/2016 Page 3/5
4 International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Ivabradine Cardiac therapy 3 Methotrexate 2 Miglustat Other alimentary tract and 1 metabolism products Palonosetron Antiemetics and antinauseants 2 Pegfilgrastim Immunostimulants 2 Pemetrexed 1 Rasagiline Anti-parkinson medicines 1 Rituximab 1 Sildenafil Urologicals 2 Tenofovir disoproxil 2 Teriparatide 2 Zonisamide Antiepileptics 1 Orphan medicinal products International non-proprietary name (salt, ester, derivative, etc.) / Common Name Aceneuramic acid Albutrepenonacog alfa Allogeneic t cells genetically modified to express suicide gene Amikacin Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cdna sequence Begelomab Cediranib (maleate) Chenodeoxycholic acid Chlormethine Daratumumab Therapeutic area 3 Other medicines for disorders of the musculo-skeletal system Antibacterials for systemic use Immunostimulants Bile and liver therapy 3 Based on the ATC therapeutic sub-group. EMA/6499/2016 Page 4/5
5 International non-proprietary name (salt, ester, derivative, etc.) / Common Name Dinutuximab beta Drisapersen (sodium) Edotreotide Eftrenonacog alfa Elotuzumab Eryaspase Factor X Irinotecan (hydrochloride trihydrate) Ixazomib (citrate) Mercaptamine (hydrochloride) Migalastat (hydrochloride) Obeticholic acid Parathyroid hormone Selexipag Sirolimus Trientine (tetrahydrochloride) Venetoclax Vosaroxin Therapeutic area 3 Other medicines for disorders of the musculo-skeletal system Diagnostic radiopharmaceuticals Other alimentary tract and metabolism products Ophthalmologicals Other alimentary tract and metabolism products Bile and liver therapy Antithrombotic medicines Ophthalmologicals Other alimentary tract and metabolism products EMA/6499/2016 Page 5/5
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