EU/3/13/1150: Orphan designation for the treatment of B-lymphoblastic leukaemia/lymphoma

Moxetumomab pasudotox


On 17 July 2013, orphan designation (EU/3/13/1150) was granted by the European Commission to MedImmune Ltd, United Kingdom, for moxetumomab pasudotox for the treatment of B-lymphoblastic leukaemia / lymphoma.

The sponsorship was transferred to AstraZeneca AB, Sweden, in January 2019.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2022 on request of the Sponsor.

Key facts

Active substance
Moxetumomab pasudotox
Intended use
Treatment of B-lymphoblastic leukaemia/lymphoma
Orphan designation status
EU designation number
Date of designation

AstraZeneca AB
Södertälje SE 151 85
Tel: + 46 8 553 260 00


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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