This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 15/01/2021

Authorisation details

Product details
Agency product number
Active substance
lenvatinib mesilate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Thyroid Neoplasms
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated 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 monitoringAdditional 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
Marketing-authorisation holder
Eisai GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Edmund-Rumpler-Straße 3
60549 Frankfurt am Main

Product information

10/12/2020 Lenvima - EMEA/H/C/003727 - WS/1861/G


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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.

Assessment history

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