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
LENVIMA 4 mg hard capsules.
LENVIMA 10 mg hard capsules.
Pharmaceutical Form |
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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. |
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 | |
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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 |
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Capsule contents: Calcium carbonate Capsule shell: Hypromellose Printing ink: Shellac |
Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules. Each carton contains 30 ,60,or 90 hard capsules.
Not all pack sizes may be marketed.
Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
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
Drug | Countries | |
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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 |
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