3 August 206 EMA/52958/206 Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use August 206 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 2 August 206. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 206. Reproduction is authorised provided the source is acknowledged.
Non-orphan medicinal products International non-proprietary name (salt, ester, derivative, etc.) / Common Name Abaloparatide Alectinib (hydrochloride) Anamorelin (hydrochloride) Atezolizumab Baricitinib Bezlotoxumab Brodalumab Cariprazine (hydrochloride) Cladribine Dasabuvir (sodium) / ombitasvir / paritaprevir / ritonavir Dengue tetravalent vaccine (live, attenuated) Dimethyl fumarate Empagliflozin / linagliptin Etelcalcetide (hydrochloride) Etirinotecan pegol Fluciclovine (8F) Follitropin delta Human IgG monoclonal antibody specific for human interleukin- alpha Iloperidone Insulin aspart Insulin glargine / lixisenatide Lonoctocog alfa Meningococcal group B vaccine (recombinant, component, adsorbed) Ocrelizumab Padeliporfin (di-potassium) Palbociclib Therapeutic area Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Psycholeptics Antivirals for systemic use Vaccines Antipsoriatics Diagnostic radiopharmaceuticals Sex hormones and modulators of the genital system Psycholeptics Vaccines Based on the ATC therapeutic sub-group. EMA/52958/206 Page 2/5
International non-proprietary name (salt, ester, derivative, etc.) / Common Name Patiromer sorbitex calcium Prasterone Rolapitant Rurioctocog alfa pegol Sarilumab Sodium zirconium cyclosilicate Spheroids of human autologous matrixassociated chondrocytes Tenofovir alafenamide (fumarate) Tofacitinib (citrate) Therapeutic area Sex hormones and modulators of the genital system Antiemetics and antinauseants Other medicines for disorders of the musculo-skeletal system Antivirals for systemic use Non-orphan generic and biosimilar medicinal products International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Adalimumab 3 Carglumic acid Carmustine Daptomycin Antibacterials for systemic use Darunavir Antivirals for systemic use Efavirenz / emtricitabine / Antivirals for systemic use tenofovir disoproxil Emtricitabine / tenofovir disoproxil Antivirals for systemic use 3 Ertapenem Antibacterials for systemic use Etanercept Febuxostat Antigout medicines Insulin glargine Ivabradine Cardiac therapy 3 Methotrexate Miglustat 2 Based on the ATC therapeutic sub-group. EMA/52958/206 Page 3/5
International non-proprietary name / Common Name Therapeutic area 2 Total number of applications Nitisinone Pegfilgrastim Immunostimulants 4 Pemetrexed 2 Pregabalin Antiepileptics Rituximab 2 Sildenafil Urologicals Tadalafil Urologicals Tenofovir disoproxil Antivirals for systemic use Teriparatide 2 Tigecycline Antibacterials for systemic use Orphan medicinal products International non-proprietary name (salt, ester, derivative, etc.) / Common Name Aceneuramic acid Alpha--antitrypsin Amikacin Cediranib (maleate) Chenodeoxycholic acid Chlormethine Dinutuximab beta Edotreotide Eryaspase Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue Inotuzumab ozogamicin Lutetium (77Lu) dotatate Therapeutic area 3 Other medicines for disorders of the musculo-skeletal system Antibacterials for systemic use Bile and liver therapy Diagnostic radiopharmaceuticals Therapeutic radiopharmaceuticals 3 Based on the ATC therapeutic sub-group. EMA/52958/206 Page 4/5
International non-proprietary name (salt, ester, derivative, etc.) / Common Name Masitinib (mesylate) Mercaptamine (hydrochloride) Nonacog beta pegol Obeticholic acid Olaratumab Paclitaxel Pacritinib (citrate) Parathyroid hormone Pentosan polysulfate sodium Telotristat (etiprate) Tivozanib (hydrochloride monohydrate) Trientine (tetrahydrochloride) Venetoclax Vosaroxin Therapeutic area 3 Ophthalmologicals Bile and liver therapy Urologicals metabolism products EMA/52958/206 Page 5/5