EU/3/12/1039: Orphan designation for the treatment of cutaneous T-cell lymphoma

Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein


On 9 August 2012, orphan designation (EU/3/12/1039) was granted by the European Commission to AOP Orphan Pharmaceuticals AG, Austria, for recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for the treatment of cutaneous T-cell lymphoma.

In February 2022, the sponsor’s address was updated and the name was changed from AOP Orphan Pharmaceuticals AG to Aop Orphan Pharmaceuticals GmbH.

Key facts

Active substance
Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein
Intended use
Treatment of cutaneous T-cell lymphoma
Orphan designation status
EU designation number
Date of designation

Aop Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna

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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