4 July 2016 EMA/462942/2016 Information Management Division

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 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 4 July 2016. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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.

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Non-orphan medicinal products International non-proprietary name

Therapeutic area1

(salt, ester, derivative, etc.) / Common Name Abaloparatide

Calcium homeostasis

Alectinib (hydrochloride)

Antineoplastic medicines

Anamorelin (hydrochloride)

Other therapeutic medicines

Atezolizumab

Antineoplastic medicines

Baricitinib

Immunosuppressants

Bezlotoxumab Brodalumab

Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Immunosuppressants

Cabozantinib (S-malate)

Antineoplastic medicines

Cariprazine (hydrochloride)

Psycholeptics

Dasabuvir (sodium) / ombitasvir / paritaprevir / ritonavir Dengue tetravalent vaccine (live, attenuated) Dimethyl fumarate

Antivirals for systemic use

Eluxadoline Empagliflozin / linagliptin

Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Medicines used in diabetes

Etelcalcetide (hydrochloride)

Calcium homeostasis

Fluciclovine (18F)

Diagnostic radiopharmaceuticals

Follitropin delta

Sex hormones and modulators of the genital system

Human IgG1 monoclonal antibody specific for human interleukin-1 alpha Iloperidone

Antineoplastic medicines

Insulin aspart

Medicines used in diabetes

Insulin glargine / lixisenatide

Medicines used in diabetes

Lenvatinib (mesilate)

Antineoplastic medicines

Lonoctocog alfa

Antihemorrhagics

Meningococcal group B vaccine (recombinant, component, adsorbed) Ocrelizumab

Vaccines

Padeliporfin (di-potassium)

Antineoplastic medicines

1

Vaccines Antipsoriatics

Psycholeptics

Immunosuppressants

Based on the ATC therapeutic sub-group.

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/462942/2016

Page 2/5

Therapeutic area1

International non-proprietary name (salt, ester, derivative, etc.) / Common Name Palbociclib

Antineoplastic medicines

Patiromer sorbitex calcium

Other therapeutic medicines

Prasterone

Sex hormones and modulators of the genital system

Rolapitant

Antiemetics and antinauseants

Rurioctocog alfa pegol

Antihemorrhagics

Sodium zirconium cyclosilicate

Other therapeutic medicines

Spheroids of human autologous matrixassociated chondrocytes Tenofovir alafenamide (fumarate)

Other medicines for disorders of the musculo-skeletal system Antivirals for systemic use

Tofacitinib (citrate)

Immunosuppressants

Non-orphan generic and biosimilar medicinal products International non-proprietary

Therapeutic area2

name / Common Name

Total number of applications

Adalimumab

Immunosuppressants

2

Carglumic acid

1

Carmustine

Other alimentary tract and metabolism products Antineoplastic medicines

1

Daptomycin

Antibacterials for systemic use

1

Darunavir

Antivirals for systemic use

1

Emtricitabine / tenofovir disoproxil

Antivirals for systemic use

3

Enoxaparin sodium

Antithrombotic medicines

2

Ertapenem

Antibacterials for systemic use

1

Etanercept

Immunosuppressants

1

Febuxostat

Antigout medicines

1

Insulin glargine

Medicines used in diabetes

1

Ivabradine

Cardiac therapy

3

Methotrexate

Antineoplastic medicines

1

Miglustat

Other alimentary tract and metabolism products

1

2

Based on the ATC therapeutic sub-group.

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/462942/2016

Page 3/5

International non-proprietary

Therapeutic area2

name / Common Name Nitisinone

Total number of applications 1

Pegfilgrastim

Other alimentary tract and metabolism products Immunostimulants

Pemetrexed

Antineoplastic medicines

2

Pregabalin

Antiepileptics

1

Rituximab

Antineoplastic medicines

2

Sildenafil

Urologicals

2

Tadalafil

Urologicals

1

Tenofovir disoproxil

Antivirals for systemic use

2

Teriparatide

Calcium homeostasis

2

Tigecycline

Antibacterials for systemic use

1

4

Orphan medicinal products

International non-proprietary name (salt,

Therapeutic area3

ester, derivative, etc.) / Common Name Aceneuramic acid Alpha-1-antitrypsin

Other medicines for disorders of the musculoskeletal system Antihemorrhagics

Amikacin

Antibacterials for systemic use

Begelomab

Immunosuppressants

Cediranib (maleate)

Antineoplastic medicines

Chenodeoxycholic acid

Bile and liver therapy

Chlormethine

Antineoplastic medicines

Dinutuximab beta

Antineoplastic medicines

Edotreotide

Diagnostic radiopharmaceuticals

Eryaspase

Antineoplastic medicines

Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue Inotuzumab ozogamicin

Immunosuppressants

3

Antineoplastic medicines

Based on the ATC therapeutic sub-group.

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/462942/2016

Page 4/5

International non-proprietary name (salt,

Therapeutic area3

ester, derivative, etc.) / Common Name Irinotecan (hydrochloride trihydrate)

Antineoplastic medicines

Lutetium (177Lu) dotatate

Therapeutic radiopharmaceuticals

Masitinib (mesylate)

Antineoplastic medicines

Mercaptamine (hydrochloride)

Ophthalmologicals

Nonacog beta pegol

Antihemorrhagics

Obeticholic acid

Bile and liver therapy

Olaratumab

Antineoplastic medicines

Paclitaxel

Antineoplastic medicines

Pacritinib (citrate)

Antineoplastic medicines

Parathyroid hormone

Calcium homeostasis

Pentosan polysulfate sodium

Urologicals

Tivozanib (hydrochloride monohydrate)

Antineoplastic medicines

Trientine (tetrahydrochloride) Venetoclax

Other alimentary tract and metabolism products Antineoplastic medicines

Vosaroxin

Antineoplastic medicines

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/462942/2016

Page 5/5

July 2016 - European Medicines Agency - Europa EU

Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).

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