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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2016 at the end of the period of market exclusivity.

On 14 February 2001, orphan designation (EU/3/01/025) was granted by the European Commission to ClinTrials Research Limited, United Kingdom, for N-acetylgalactosamine-4-sulfatase for the treatment of mucopolysaccharidosis, type VI (Maroteaux-Lamy syndrome).

The sponsorship was transferred to Dr. Gertrud Thormann, France in December 2002 and subsequently to BioMarin Europe Ltd, Ireland, in January 2005.

N-acetylgalactosamine-4-sulfatase has been authorised in the EU as Naglazyme since 24 January 2006.

Key facts

Active substance
N-acetylgalactosamine 4-sulfatase
Medicine name
Disease / condition
Treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome)
Date of first decision
EU designation number

Sponsor's contact details

BioMarin Europe Ltd.
10 Bloomsbury Way
London WC1A 2SL
United Kingdom
Tel. + 44 (0)20 7420 0800
Fax + 44 (0)20 7420 0829

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.

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