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.
Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
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Turnkey PharmaConsulting Ireland Limited
Documents related to this orphan designation evaluation
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: