Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lonsurf   
Auth. number : EU/1/16/1096
Active substance : trifluridine / tipiracil
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC59 - trifluridine, combinations
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/04/2016 Centralised - Authorisation EMEA/H/C/3897 (2016)2631 of 25/04/2016
23/03/2017 Centralised - Variation EMEA/H/C/3897/II/02/G
24/04/2017 Centralised - Variation EMEA/H/C/3897/IAIN/05/G
14/08/2017 Centralised - Variation EMEA/H/C/3897/IB/0008