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On 22 September 2008, orphan designation (EU/3/08/569) was granted by the European Commission to Enzon (UK) Limited, United Kingdom, for pegylated L-asparaginase for the treatment of acute lymphoblastic leukaemia.

The sponsorship was transferred to Defiante Farmacêutica, S.A., Portugal, in September 2010 and subsequently to Sigma-tau Rare Diseases S.A., Portugal, in November 2012.

Key facts

Active substance
Pegylated L-asparaginase
Disease / condition
Treatment of acute lymphoblastic leukaemia
Date of first decision
EU designation number

Sponsor's contact details

Sigma-tau Rare Diseases S.A.
Rua dos Ferreiros, 260
9000-082 Funchal
Tel. +351 291 20 30 70
Fax +351 291 20 30 79

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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