tegafur / gimeracil / oteracil
Teysuno is a cancer medicine. It belongs to a group of cancer medicines called fluoropyrimidines and is used to treat advanced gastric (stomach) cancer together with cisplatin (another cancer medicine). It is also used to treat metastatic colorectal cancer (cancer of the colon and rectum that has spread elsewhere in the body) in patients who can no longer be treated with other fluoropyrimidines because of unacceptable side effects. For this it may be used alone or with the cancer medicines oxaliplatin or irinotecan, with or without another medicine, bevacizumab.
Teysuno contains the active substances tegafur, gimeracil and oteracil.
Teysuno : EPAR - Medicine overview (PDF/150.76 KB)
First published: 30/03/2011
Last updated: 28/02/2022
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Nordic Group B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
24/01/2022 Teysuno - EMEA/H/C/001242 - II/0045
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.
Teysuno is indicated in adults:
- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
- as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 202117/12/2021
EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine30/04/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015