Lonsurf
trifluridine / tipiracil
Table of contents
Overview
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.
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List item
Lonsurf : EPAR - Medicine overview (PDF/77.41 KB)
First published: 12/05/2016
Last updated: 08/10/2019
EMA/473164/2019 -
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List item
Lonsurf : EPAR - Risk-management-plan summary (PDF/205.95 KB)
First published: 08/10/2019
Last updated: 19/05/2020
Authorisation details
Product details | |
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Name |
Lonsurf
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Agency product number |
EMEA/H/C/003897
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Colorectal Neoplasms
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Anatomical therapeutic chemical (ATC) code |
L01BC
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Publication details | |
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Marketing-authorisation holder |
Les Laboratoires Servier
|
Revision |
7
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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
15/09/2021 Lonsurf - EMEA/H/C/003897 - N/0023
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.