EU/3/20/2372: Orphan designation for the treatment of glioma

Dabrafenib mesylate

Overview

On 9 December 2020, orphan designation EU/3/20/2372 was granted by the European Commission to Novartis Europharm Limited, Ireland, for dabrafenib mesylate for the treatment of glioma.

Key facts

Active substance
Dabrafenib mesylate
Intended use
Treatment of glioma
Orphan designation status
Positive
EU designation number
EU/3/20/2372
Date of designation
09/12/2020
Sponsor

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Tel.: +41 (0)61 324 11 11
E-mail: orphan.enquiries@novartis.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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