Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
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1 4 February 205 EMA/82478/205 Procedure Management and Business Support Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use February 205 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 4 February 205. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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 E4 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, 205. Reproduction is authorised provided the source is acknowledged.
2 Non-orphan medicinal International non-proprietary name (salt, ester, derivative, etc.) / Common Name Alirocumab Atazanavir (sulfate) / cobicistat Betulae cortex dry extract (5-0 : ); extraction solvent: n-heptane 95% (w/w) Brivaracetam Ceftolozane (sulfate) / tazobactam (sodium) Ceritinib Cobimetinib (hemifumarate) Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Edoxaban (tosylate) Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide Empagliflozin / metformin (hydrochloride) Evolocumab Fentanyl (hydrochloride) Ferric citrate coordination complex Ferric maltol Guanfacine (hydrochloride) Human alpha-proteinase inhibitor Human fibrinogen / human thrombin Human papillomavirus vaccine [types 6,, 6, 8, 3, 33, 45, 52, 58] (recombinant, adsorbed) Lesinurad Levodopa /carbidopa (monohydrate) Lutetium (77 Lu) (chloride) Mepolizumab Necitumumab Netupitant / palonosetron (hydrochloride) Therapeutic area Lipid modifying medicines Antivirals for systemic Medicines for wounds and ulcers Antiepileptics Antibacterials for systemic Vaccines Antithrombotic medicines Antivirals for systemic Medicines d in diabetes Lipid modifying medicines Analgesics Other therapeutic medicines Antianemic medicines Antihypertensives Vaccines Antigout medicines Anti-parkinson medicines Diagnostic radiopharmaceuticals Immunosuppressants Antiemetics and antinaants Based on the ATC therapeutic sub-group. EMA/82478/205 Page 2/5
3 International non-proprietary name (salt, ester, derivative, etc.) / Common Name Nivolumab Octocog alfa Opicapone Pegaspargase Pegfilgrastim Pembrolizumab Phenylephrine (hydrochloride) / ketorolac (trometamol) Sacubitril / valsartan Sonidegib (phosphate) Spheroids of human autologous matrixassociated chondrocytes Talimogene laherparepvec Therapeutic area Anti-parkinson medicines Immunostimulants Ophthalmologicals Cardiovascular system Other medicines for disorders of the musculo-skeletal system Non-orphan generic and biosimilar medicinal International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Aripiprazole Psycholeptics 5 Atazanavir Antivirals for systemic Bortezomib Cinacalcet Calcium homeostasis Docetaxel Duloxetine Psychoanaleptics 3 Eptifibatide Antithrombotic medicines Etanercept Immunosuppressants Insulin human Medicines d in diabetes Lopinavir / ritonavir Antivirals for systemic 2 Based on the ATC therapeutic sub-group. EMA/82478/205 Page 3/5
4 International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Pemetrexed 6 Pregabalin Antiepileptics 6 Sufentanil Anesthetics Voriconazole Antimycotics for systemic Orphan medicinal 3 International non-proprietary name (salt, ester, derivative, etc.) / Common Name Allogeneic human heterologous liver cells Allogeneic T cells genetically modified to express suicide gene Asfotase alfa Blinatumomab Dasiprotimut-T Dexamethasone (acetate) Dinutuximab Efmoroctocog alfa Glycerol phenylbutyrate Idebenone Isavuconazole (isavuconazonium sulfate) Ketoconazole Lenvatinib (mesylate) Lumacaftor / ivacaftor Mercaptamine (hydrochloride) Mifepristone Panobinostat (lactate anhydrous) Therapeutic area 4 Immunostimulants Corticosteroids for systemic Other nervous system medicines Antimycotics for systemic Other therapeutic medicines Other respiratory system medicines Ophthalmologicals Systemic hormonal preparations, excl. sex hormones and insulins 3 In line with the Principles for publication of agendas and minutes of EMA scientific committees (EMA/555647/203), and further to the information in the CHMP Minutes of March 204 that the invented names of orphan would no longer be disclosed in the Agendas and Minutes of the CHMP, this document includes (from September 204 onwards) only the international non-proprietary names (INN) and therapeutic areas for designated orphan medicines under evaluation. 4 Based on the ATC therapeutic sub-group. EMA/82478/205 Page 4/5
5 International non-proprietary name (salt, ester, derivative, etc.) / Common Name Parathyroid hormone Pitolisant (hydrochloride) Recombinant L-asparaginase Sebelipase alfa Selexipag Susoctocog alfa Tasimelteon Tolvaptan Therapeutic area 4 Calcium homeostasis Psychoanaleptics Antithrombotic medicines Psycholeptics Urologicals EMA/82478/205 Page 5/5
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