EU/3/07/447: Orphan designation for the treatment of gastrointestinal stromal tumours

Nilotinib hydrochloride monohydrate

Table of contents


Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2013 on request of the sponsor.

On 13 April 2007, orphan designation (EU/3/07/447) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for nilotinib hydrochloride monohydrate for the treatment of gastrointestinal stromal tumours.

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

Key facts

Active substance
Nilotinib hydrochloride monohydrate
Intended use
Treatment of 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:

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

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

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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