EU/3/07/444: Orphan designation for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)

Pralatrexate

Table of contents

Overview

On 13 April 2007, orphan designation (EU/3/07/444) was granted by the European Commission to Oxford Regulatory Solutions Ltd, United Kingdom, for pralatrexate for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).

The sponsorship was transferred

  • to European Medical Advisory Services Limited, United Kingdom, in December 2007
  • to Allos Therapeutics Limited, United Kingdom, in April 2010
  • to Regintel Limited, Ireland, in April 2020 and
  • to Turnkey Pharmaconsulting Ireland Limited, Ireland, in July 2020.

 

Key facts

Active substance
Pralatrexate
Intended use
Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Orphan designation status
Positive
EU designation number
EU/3/07/444
Date of designation
13/04/2007
Sponsor

Turnkey PharmaConsulting Ireland Limited
Ellerman House 
Cratloe Wood 
Cratloe V95 X925
County Clare 
Ireland 
Tel: +353 86 844 6816 
E-mail: markturner@turnkeypharmaconsulting.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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