Lenvima

RSS

lenvatinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 22/10/2018

Authorisation details

Product details
Name
Lenvima
Agency product number
EMEA/H/C/003727
Active substance
lenvatinib mesylate
International non-proprietary name (INN) or common name
lenvatinib
Therapeutic area (MeSH)
Thyroid Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE
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
Marketing-authorisation holder
Eisai Europe Ltd
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address
European Knowledge Centre
Mosquito Way
Hertfordshire
Hatfield AL10 9SN
United Kingdom

Product information

19/08/2018 Lenvima - EMEA/H/C/003727 - II/0011/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 (see section 5.1).

Assessment history

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