ALDURAZYME

Product Information

Registration Status: Active

ALDURAZYME is approved to be sold in Singapore with effective from 2007-08-28. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN13347P.

This product contains Laronidase 2.9mg in the form of INJECTION, SOLUTION. It is approved for INTRAVENOUS use.

This product is manufactured by Jubilant HollisterStier LLC in UNITED STATES, andVetter Pharma-Fertigung GmbH & Co. KG in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Laronidase

Description

Human recombinant alpha-L-iduronidase, 628 residues (mature form), produced by recombinant DNAtechnology in a Chinese hamster ovary cell line. Laronidase is a glycoprotein with a molecular weight of approximately 83 kD. The predicted amino acid sequence of the recombinant form, as well as the nucleotide sequence that encodes it, are identical to a polymorphic form of human a-L-iduronidase. It contains 6 N-linked oligosaccharide modification sites.

Indication

For the treatment of mucopolysaccharidosis

Mechanism of Action

Laronidase catalyses the hydrolysis of terminal alpha-L-iduronic acid residues of dermatan sulfate and heparin sulfate.

Active Ingredient/Synonyms

Alpha-L-iduronidase precursor | Laronidase |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank