12 July 2018 EMA/482350/2018 Corr. Information Management Division

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 2018

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 12 July 2018. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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 Abemaciclib

Antineoplastic medicines

Andexanet alfa

Other therapeutic medicines

Angiotensin II (acetate)

Medicines acting on the renin-angiotensin system

Apalutamide

Endocrine therapy

Avatrombopag (maleate)

Antihemorrhagics

Axalimogene filolisbac

Antineoplastic medicines

Binimetinib

Antineoplastic medicines

Botulinum toxin type A

Muscle relaxants

Brigatinib

Antineoplastic medicines

Buprenorphine (hydrochloride)

Other nervous system medicines

Canakinumab

Immunosuppressants

Cemiplimab

Antineoplastic medicines

Ciprofloxacin

Antibacterials for systemic use

Crisaborole

Other dermatological medicines

Dacomitinib (monohydrate)

Antineoplastic medicines

Delafloxacin (meglumine)

Antibacterials for systemic use

Dengue tetravalent vaccine (live, attenuated) Doravirine

Vaccines

Doravirine / lamivudine / tenofovir disoproxil (fumarate) Durvalumab

Antivirals for systemic use

Edaravone

Other nervous system medicines

Encorafenib

Antineoplastic medicines

Eravacycline

Antibacterials for systemic use

Fremanezumab

Analgesics

Galcanezumab

Analgesics

Glycopyrronium / formoterol (fumarate dihydrate) Influenza vaccine surface antigen inactivated prepared in cell cultures

Medicines for obstructive airway diseases

Antivirals for systemic use

Antineoplastic medicines

Vaccines

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/482350/2018

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International non-proprietary name

Therapeutic area

i

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

Anti-parkinson medicines

L-lysine (hydrochloride) / L-arginine (hydrochloride) Lorlatinib

Urologicals

Lusutrombopag

Antihemorrhagics

Macimorelin (acetate)

Diagnostic medicines

Melatonin

Psycholeptics

Meropenem (trihydrate) /vaborbactam

Antibacterials for systemic use

Naldemedine (tosilate)

Medicines for constipation

Risankizumab

Immunosuppressants

Romosozumab

Medicines for bone diseases

Sotagliflozin

Medicines used in diabetes

Talazoparib

Antineoplastic medicines

Tildrakizumab

Immunosuppressants

Zanamivir

Antivirals for systemic use

Antineoplastic medicines

Based on the ATC therapeutic sub-group. Correction: Angiotensin II (acetate) application was first recorded as being reviewed under EMA’s accelerated assessment programme, which is not the case. i

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

Therapeutic area

i

Common Name

Total number of applications

Adalimumab

Immunosuppressants

2

Ambrisentan

Antihypertensives

2

Atazanavir

Antivirals for systemic use Antineoplastic medicines Other nervous system medicines Antineoplastic medicines Other therapeutic medicines Antineoplastic medicines

1

Bevacizumab Buprenorphine Cabazitaxel Deferiprone Doxorubicin

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/482350/2018

1 1 1 1 1

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International non-proprietary name /

Therapeutic area

i

Common Name

Total number of applications

Etanercept

Immunosuppressants

1

Febuxostat

Antigout medicines

1

Gefitinib

Antineoplastic medicines Antineoplastic medicines Diagnostic radiopharmaceuticals Immunosuppressants

1

Other alimentary tract and metabolism products Antineoplastic medicines Immunostimulants

1

Antimycotics for systemic use Antineoplastic medicines Urologicals

1

Antineoplastic medicines Antiepileptics

1

Hydroxycarbamide Ioflupane (123I) Lenalidomide Miglustat

Paclitaxel Pegfilgrastim Posaconazole Rituximab Silodosin Trastuzumab Vigabatrin i

1 1 1

1 8

1 1

1

Based on the ATC therapeutic sub-group.

Orphan medicinal products

International non-proprietary name (salt, ester,

Therapeutic area

i

derivative, etc.) / Common Name Asparaginase

Antineoplastic medicines

Avacopan

Immunosuppressants

Cannabidiol

Antiepileptics

Damoctocog alfa pegol

Antihemorrhagics

Enasidenib (mesylate)

Antineoplastic medicines

Entolimod

Immunostimulants

Glutamine

Other alimentary tract and metabolism products Other hematological medicines

Lanadelumab ii

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/482350/2018

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International non-proprietary name (salt, ester,

Therapeutic area

i

derivative, etc.) / Common Name Mexiletine (hcl) Mogamulizumab

Other medicines for disorders of the musculo-skeletal system Antineoplastic medicines

Paclitaxel

Antineoplastic medicines

Pacritinib (citrate)

Antineoplastic medicines

Patisiran (sodium) ii

Other nervous system medicines

Pegvaliase Ropeginterferon alfa-2b

Other alimentary tract and metabolism products Immunostimulants

Tezacaftor / ivacaftor

Other respiratory system medicines

Treosulfan

Antineoplastic medicines

Treprostinil

Antithrombotic medicines

Trientine (dihydrochloride)

Other alimentary tract and metabolism products Antihemorrhagics

Turoctocog alfa pegol Viable T-cells Volanesorsen (sodium)

Antineoplastic and immunomodulating agents Lipid modifying medicines

Voretigene neparvovec

Ophthalmologicals

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/482350/2018

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July 2018 - European Medicines Agency - Europa EU

Jul 12, 2018 - An agency of the European Union ... This list only includes information for medicines whose applications have been validated at the time the.

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