Aldurazyme (laronidase)
- Region
- 🇪🇺 EU
- Active substance
- laronidase
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Mucopolysaccharidosis I
- CHMP opinion
- Thu 20 Feb 2003
- EU approval
- Mon 09 Jun 2003
- Application
- EMEA/H/C/000477
- ATC
- A16AB05
- Official record
- www.ema.europa.eu
Indication
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.