EU/3/07/515: Orphan designation for the treatment of gastric cancer

tegafur / gimeracil / oteracil potassium

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2016 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 20 December 2007, orphan designation (EU/3/07/515) was granted by the European Commission to Sanofi Aventis, France, for tegafur, gimeracil, oteracil potassium for the treatment of gastric cancer.

The sponsorship was transferred to Quintiles Ireland Ltd in February 2009 and subsequently to Taiho Pharma Europe Limited, United Kingdom, in May 2009.

Key facts

Active substance
  • tegafur
  • gimeracil
  • oteracil potassium
Intended use
Treatment of gastric cancer
Orphan designation status
EU designation number
Date of designation

Taiho Pharma Europe Limited
11th Floor
Two Snowhill
Snow Hill Queensway
Birmingham B4 6WR
United Kingdom
Tel: +1 609 250 7292

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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