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

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Eisai GmbH, Edmund-Rumpler-Straße 3,60549 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 VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.

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, Edmund-Rumpler-Straße 3,60549 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Marketing authorization dates and numbers

Lenvima 4 mg 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
Date of latest renewal: 20 May 2020

Drugs

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

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