EU/3/01/078

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2017 at the end of the period of market exclusivity.

On 11 December 2001, orphan designation (EU/3/01/078) was granted by the European Commission to TKT UK Limited, United Kingdom, for iduronate-2-sulfatase for the treatment of mucopolysaccharidosis, type II (Hunter Syndrome).

The sponsorship was transferred to TKT Europe AB, Sweden, in December 2005.

The sponsor changed its name to Shire Human Genetic Therapies AB in February 2010.

Iduronate-2-sulfatase has been authorised in the EU as Elaprase since 8 January 2007.

Key facts

Active substance
Iduronate-2-sulfatase
Medicine name
Elaprase
Disease / condition
Treatment of mucopolysaccharidosis, type II (Hunter Syndrome)
Date of first decision
11/12/2001
Outcome
Expired
EU designation number
EU/3/01/078

Review of designation

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2017 at the end of the period of market exclusivity.

Sponsor's contact details

Shire Human Genetic Therapies AB
Svärdvägen 11D
182 33 Danderyd
Sweden
Tel. +46 8 5449 6400
Fax +46 8 5449 6429

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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