Lonsurf

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trifluridine / tipiracil

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

Overview

Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer that is metastatic (has spread to other parts of the body). It is used in patients who have already been treated with, or who cannot be given, other treatments for their cancer. It can be used in combination with bevacizumab (another cancer medicine) to treat colorectal cancer.

Lonsurf contains the active substances trifluridine and tipiracil.

This EPAR was last updated on 11/09/2023

Authorisation details

Product details
Name
Lonsurf
Agency product number
EMEA/H/C/003897
Active substance
  • trifluridine
  • tipiracil hydrochloride
International non-proprietary name (INN) or common name
  • trifluridine
  • tipiracil
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01BC59
Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
25/04/2016
Contact address
50 rue Carnot
92284 Suresnes cedex
France

Product information

26/07/2023 Lonsurf - EMEA/H/C/003897 - II/0026

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Colorectal cancer

Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.

Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agents

Gastric cancer

Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Assessment history

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