Lenvima
lenvatinib
Table of contents
Overview
Lenvima is a cancer medicine used on its own to treat:
- adults with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine.
- adults with hepatocellular carcinoma (a type of liver cancer) who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery.
Lenvima contains the active substance lenvatinib.
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List item
Lenvima : EPAR - Medicine overview (PDF/83.76 KB)
First published: 25/06/2015
Last updated: 22/10/2018
EMA/487404/2018 -
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List item
Lenvima : EPAR - Risk-management-plan summary (PDF/92.8 KB)
First published: 25/06/2015
Last updated: 25/06/2015
Authorisation details
Product details | |
---|---|
Name |
Lenvima
|
Agency product number |
EMEA/H/C/003727
|
Active substance |
lenvatinib mesilate
|
International non-proprietary name (INN) or common name |
lenvatinib
|
Therapeutic area (MeSH) |
Thyroid Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01XE
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Eisai GmbH
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
28/05/2015
|
Contact address |
Product information
10/12/2020 Lenvima - EMEA/H/C/003727 - WS/1861/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.