EU/3/16/1722: Orphan designation for the treatment of amyotrophic lateral sclerosis

Masitinib mesilate


On 29 August 2016, orphan designation (EU/3/16/1722) was granted by the European Commission to AB Science, France, for masitinib mesilate for treatment of amyotrophic lateral sclerosis.

Key facts

Active substance
Masitinib mesilate
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
EU designation number
Date of designation
AB Science
3, avenue George V
75008 Paris
Tel. +33 1472 02311
Fax +33 1472 02411

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:

  • 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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