EU/3/12/953: Orphan designation for the treatment of West syndrome

(1S,3S)-3-amino-4-(difluoromethylene) cyclopentanecarboxylic acid hydrochloride


On 9 February 2012, orphan designation (EU/3/12/953) was granted by the European Commission to Catalent Pharma Solutions Limited, United Kingdom, for (1S,3S)-3-amino-4-(difluoromethylene) cyclopentanecarboxylic acid hydrochloride for the treatment of West syndrome.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in January 2021 on request of the Sponsor.

Key facts

Active substance
(1S,3S)-3-amino-4-(difluoromethylene) cyclopentanecarboxylic acid hydrochloride
Intended use
Treatment of West syndrome
Orphan designation status
EU designation number
Date of designation
Catalent Pharma Solutions Limited
Frankland Road
Wilts SN5 8YG
United Kingdom
Tel. +44 (0)1793 864000
Fax +44 (0)1793 613394

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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