Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Eisai Europe Limited, European Knowledge Centre, Mosquito Way, Hatfield, AL10 9SN, United Kingdom
Kisplyx 4 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 4 mg hard capsules:
Each hard capsule contains 4 mg of lenvatinib (as mesilate).
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 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 Europe Limited, European Knowledge Centre, Mosquito Way, Hatfield, AL10 9SN, United Kingdom
PLGB 33967/0007
Date of first authorisation: 01 January 2021
Date of latest renewal: 01 September 2021
| Drug | Countries | |
|---|---|---|
| KISPLYX | Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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