EU/3/01/061: Orphan designation for the treatment of malignant gastrointestinal stromal tumours

imatinib mesilate

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2012 on request of the sponsor.

On 20 November 2001, orphan designation (EU/3/01/061) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of malignant gastrointestinal stromal tumours.

Imatinib mesilate for treatment of malignant gastrointestinal stromal tumours has been authorised in the EU as Glivec since 24 May 2002.

For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.

Key facts

Active substance
imatinib mesilate
Medicine name
Intended use
Treatment of malignant gastrointestinal stromal tumours
Orphan designation status
EU designation number
Date of designation

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom
Tel. +41 61 324 11 11 (Switzerland)

Documents related to this orphan designation evaluation

Patients' organisations

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

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • 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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