trifluridine / tipiracil

This medicine is authorised for use in the European Union.


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

Lonsurf contains the active substances trifluridine and tipiracil.

This EPAR was last updated on 08/10/2019

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

03/09/2019 Lonsurf - EMEA/H/C/003897 - II/0012


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Metastatic colorectal cancer

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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