trifluridine / tipiracil

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Lonsurf. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lonsurf.

For practical information about using Lonsurf, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 24/05/2019

Authorisation details

Product details
Agency product number
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
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
Les Laboratoires Servier
Date of issue of marketing authorisation valid throughout the European Union
Contact address
50 rue Carnot
92284 Suresnes cedex

Product information

03/04/2019 Lonsurf - EMEA/H/C/003897 - IA/0013/G


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Lonsurf is indicated 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.

Assessment history

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