Teysuno

RSS

tegafur / gimeracil / oteracil

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

Overview

This is a summary of the European public assessment report (EPAR) for Teysuno. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Teysuno.

This EPAR was last updated on 13/01/2020

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
17
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

08/08/2019 Teysuno - EMEA/H/C/001242 - IB/0041

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.

Assessment history

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