EU/3/16/1760: Orphan designation for the treatment in haematopoietic stem cell transplantation

Radio-iodinated (131I) anti-CD45 murine monoclonal antibody

Table of contents


On 14 October 2016, orphan designation (EU/3/16/1760) was granted by the European Commission to Wainwright Associates Ltd, United Kingdom, for radio-iodinated (131I) anti-CD45 murine monoclonal antibody (also known as Iomab-B) for treatment in haematopoietic stem cell transplantation.

Key facts

Active substance
Radio-iodinated (131I) anti-CD45 murine monoclonal antibody
Intended use
Treatment in haematopoietic stem cell transplantation
Orphan designation status
EU designation number
Date of designation

Immedica Pharma AB
Solnavagen 3 H
113 63

Update history

September 2022The sponsorship was transferred to Immedica Pharma AB, Sweden.
October 2021Voisin Consulting S.A.R.L. changed name to Voisin Consulting Life Sciences.
April 2021The sponsorship was transferred to  Voisin Consulting S.A.R.L., France.
April 2019The sponsorship was transferred to YES Pharmaceuticals Development Services GmbH, Germany.
November 2016Wainwright Associates Ltd changed name to PharmaLex UK Services Limited.

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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