Teysuno

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tegafur / gimeracil / oteracil

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 04/04/2022

Authorisation details

Product details
Name
Teysuno
Agency product number
EMEA/H/C/001242
Active substance
  • tegafur
  • gimeracil
  • oteracil
International non-proprietary name (INN) or common name
  • tegafur
  • gimeracil
  • oteracil
Therapeutic area (MeSH)
Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code
L01BC53
Publication details
Marketing-authorisation holder
Nordic Group B.V.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
14/03/2011
Contact address

Siriusdreef 41
NL-2132 WT Hoofddorp
The Netherlands

Product information

24/01/2022 Teysuno - EMEA/H/C/001242 - II/0045

Product information documents contain:

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

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.

Assessment history

Changes since initial authorisation of medicine

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