5 July 2017 EMA/430827/2017 Information Management Division

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 2017

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 July 2017. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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 area

i

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

Calcium homeostasis

Andexanet alfa

Other therapeutic medicines

Atezolizumab

Antineoplastic medicines

Benralizumab

Medicines for obstructive airway diseases

Betrixaban

Antithrombotic medicines

Binimetinib

Antineoplastic medicines

Brexpiprazole

Psycholeptics

Brigatinib

Antineoplastic medicines

Ciclosporin

Ophthalmologicals

Darunavir (ethanolate) / cobicistat / emtricitabine / tenofovir alafenamide (fumarate) D-biotin

Antivirals for systemic use

Dengue tetravalent vaccine (live, attenuated) Dolutegravir (sodium) /rilpivirine (hydrochloride) Dupilumab

Vaccines

Enclomifene (citrate)

Sex hormones and modulators of the genital system

Erenumab

Analgesics

Ertugliflozin (L-pyroglutamic acid)

Medicines used in diabetes

Ertugliflozin (L-pyroglutamic acid) / metformin (hydrochloride) Ertugliflozin (L-pyroglutamic acid) / sitagliptin (phosphate monohydrate) Etirinotecan pegol

Medicines used in diabetes

Fluticasone furoate / umeclidinium (bromide) / vilanterol (trifenatate) Guselkumab

Medicines for obstructive airway diseases

Human fibrinogen / human thrombin

Antihemorrhagics

Human herpesvirus 3

Vaccines

Iloperidone

Psycholeptics

Melatonin

Psycholeptics

Naldemedine (tosilate)

Medicines for constipation

Vitamins

Antivirals for systemic use Immunosuppressants

Medicines used in diabetes Antineoplastic medicines

Immunosuppressants

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/430827/2017

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International non-proprietary name

Therapeutic area

i

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

Antineoplastic medicines

Ocrelizumab

Immunosuppressants

Padeliporfin (di-potassium)

Antineoplastic medicines

Peramivir

Antivirals for systemic use

Prasterone

Sex hormones and modulators of the genital system

Rurioctocog alfa pegol

Antihemorrhagics

Semaglutide

Medicines used in diabetes

Sirukumab

Immunosuppressants

Tildrakizumab

Immunosuppressants

i

Based on the ATC therapeutic sub-group.

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

Therapeutic area

i

Common Name

Total number of applications

Adalimumab

Immunosuppressants

3

Anagrelide

Antineoplastic medicines

1

Bevacizumab

Antineoplastic medicines

2

Buprenorphine / naloxone

Other nervous system medicines

1

Carmustine

Antineoplastic medicines

1

Darunavir

Antivirals for systemic use

1

Doxorubicin

Antineoplastic medicines

1

Efavirenz / emtricitabine / tenofovir disoproxil Entecavir

Antivirals for systemic use

1

Antivirals for systemic use

2

Fulvestrant

Endocrine therapy

1

Hydrocortisone

Corticosteroids for systemic use

1

Imatinib

Antineoplastic medicines

1

Infliximab

Immunosuppressants

1

Insulin glargine

Medicines used in diabetes

1

Lacosamide

Antiepileptics

1

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/430827/2017

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International non-proprietary name /

Therapeutic area

i

Total number of

Common Name Miglustat

applications Other alimentary tract and metabolism products Other therapeutic medicines

1

1

Pegfilgrastim

Other alimentary tract and metabolism products Immunostimulants

Pemetrexed

Antineoplastic medicines

1

Prasugrel

Antithrombotic medicines

1

Ritonavir

Antivirals for systemic use

1

Rotigotine

Anti-parkinson medicines

1

Sufentanil

Anesthetics

1

Tacrolimus

Immunosuppressants

1

Tigecycline

Antibacterials for systemic use

1

Trastuzumab

Antineoplastic medicines

4

Naloxone Nitisinone

i

1

3

Based on the ATC therapeutic sub-group.

Orphan medicinal products

International non-proprietary name (salt, ester,

Therapeutic area

i

derivative, etc.) / Common Name Avelumab

Antineoplastic medicines

Budesonide

ii

Burosumab

Antidiarrheals, intestinal antiinflammatory/antiinfective medicines Medicines for bone diseases

Caplacizumab

Antithrombotic medicines

Ciclosporin

ii

Ophthalmologicals

Eteplirsen Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue Gemtuzumab ozogamicin Glibenclamide Letermovir

ii

ii

Lutetium (177Lu) dotatate

Other medicines for disorders of the musculo-skeletal system Immunosuppressants

Antineoplastic medicines Medicines used in diabetes Antivirals for systemic use Therapeutic radiopharmaceuticals

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/430827/2017

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International non-proprietary name (salt, ester,

Therapeutic area

i

derivative, etc.) / Common Name Masitinib (mesylate)

Antineoplastic medicines

Metreleptin

Other alimentary tract and metabolism products

Midostaurin

Antineoplastic medicines

Niraparib (tosylate monohydrate)

Antineoplastic medicines

Paclitaxel

Antineoplastic medicines

Plitidepsin

Antineoplastic medicines

Ropeginterferon alfa-2b

Immunostimulants

Rucaparib (camsylate)

Antineoplastic medicines

Sodium benzoate

Other alimentary tract and metabolism products

Telotristat (etiprate)

Other alimentary tract and metabolism products

Velmanase alfa

Other alimentary tract and metabolism products

Vestronidase alfa

Other alimentary tract and metabolism products

Viable T-cells

Antineoplastic and immunomodulating agents

Vonicog alfa

Antihemorrhagics

i ii

Based on the ATC therapeutic sub-group. Application being reviewed under EMA’s accelerated assessment programme.

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/430827/2017

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July 2017 - European Medicines Agency - Europa EU

Jul 5, 2017 - 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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