EU/3/16/1653: Orphan designation for the treatment of cutaneous T-cell lymphoma

Resiquimod

Overview

On 28 April 2016, orphan designation (EU/3/16/1653) was granted by the European Commission to Galderma R&D, France, for resiquimod for the treatment of cutaneous T-cell lymphoma.

The sponsorship was transferred to Galderma International, France in January 2022.

Key facts

Active substance
Resiquimod
Intended use
Treatment of cutaneous T-cell lymphoma
Orphan designation status
Positive
EU designation number
EU/3/16/1653
Date of designation
28/04/2016
Sponsor

Galderma International
La Defense 4 Tour Europlaza
20 Avenue Andre Prothin
92927 Paris La Defense Cedex
France
E-mail: RegulatoryAffairsRx@galderma.com

Review of designation

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

Update history

DateUpdate
January 2022The sponsorship was transferred to Galderma International, France.

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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