LENVIMA Hard capsule Ref.[9037] Active ingredients: Lenvatinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Product name and form

LENVIMA 4 mg hard capsules.

LENVIMA 10 mg hard capsules.

Pharmaceutical Form

Hard capsule.

LENVIMA 4 mg hard capsules: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.

LENVIMA 10 mg hard capsules: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.

Qualitative and quantitative composition

LENVIMA 4 mg hard capsules: Each hard capsule contains 4 mg of lenvatinib (as mesylate).

LENVIMA 10 mg hard capsules: Each hard capsule contains 10 mg of lenvatinib (as mesylate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lenvatinib

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET. Lenvatinib has shown mainly antiangiogenic properties in vitro and in vivo, and direct inhibition of tumour growth was also observed in in vitro models.

List of Excipients

Capsule contents:

Calcium carbonate
Mannitol
Microcrystalline cellulose
Hydroxypropylcellulose
Low-substituted hydroxypropylcellulose
Talc

Capsule shell:

Hypromellose
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)

Printing ink:

Shellac
Black iron oxide (E172)
Potassium hydroxide
Propylene glycol

Pack sizes and marketing

Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules. Each carton contains 30 ,60,or 90 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Marketing authorization dates and numbers

Lenvima 4mg hard capsules:

EU/1/15/1002/001
EU/1/15/1002/003
EU/1/15/1002/004

Lenvima 10 mg hard capsules:

EU/1/15/1002/002
EU/1/15/1002/005
EU/1/15/1002/006

Date of first authorisation: 28 May 2015

Drugs

Drug Countries
LENVIMA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.