EU/3/16/1774: Orphan designation for the treatment in haematopoietic stem cell transplantation

allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 / dexamethasone

Table of contents

Overview

On 18 November 2016, orphan designation (EU/3/16/1774) was granted by the European Commission to Fate Therapeutics Ltd, United Kingdom, for allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone (also known as ProTmune) for treatment in haematopoietic stem cell transplantation.

The sponsorship was transferred to Fate Therapeutics B.V., the Netherlands, in May 2019.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in August 2022 on request of the Sponsor.

Key facts

Active substance
  • allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2
  • dexamethasone
Intended use
Treatment in haematopoietic stem cell transplantation
Orphan designation status
Withdrawn
EU designation number
EU/3/16/1774
Date of designation
18/11/2016
Sponsor

Fate Therapeutics B.V.
Kingsfordweg 151
1043 GR Amsterdam
Noord-Holland
The Netherlands
E-mail: info@fatetherapeutics.com

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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