Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Eisai GmbH, Edmund-Rumpler-Straße 3, 60549 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
Kisplyx 4 mg hard capsules.
Kisplyx 10 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Kisplyx 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. Kisplyx 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. |
Kisplyx 4 mg hard capsules:
Each hard capsule contains 4 mg of lenvatinib (as mesilate).
Kisplyx 10 mg hard capsules:
Each hard capsule contains 10 mg of lenvatinib (as mesilate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 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, Edmund-Rumpler-Straße 3, 60549 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
Kisplyx 4 mg hard capsules:
EU/1/16/1128/001
EU/1/16/1128/003
EU/1/16/1128/004
Kisplyx 10 mg hard capsules:
EU/1/16/1128/002
EU/1/16/1128/005
EU/1/16/1128/006
Date of first authorisation: 25 August 2016
Date of latest renewal: 17 June 2021
| Drug | Countries | |
|---|---|---|
| KISPLYX | Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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