EU/3/18/2017: Orphan designation for the treatment of amyotrophic lateral sclerosis

Ambroxol hydrochloride


On 25 May 2018, orphan designation (EU/3/18/2017) was granted by the European Commission to Spedding Research Solutions SAS, France, for ambroxol hydrochloride for the treatment of amyotrophic lateral sclerosis.

Key facts

Active substance
Ambroxol hydrochloride
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
EU designation number
Date of designation
Spedding Research Solutions SAS
6 rue Ampère
78110 Le Vésinet
Tel. +33637059188

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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