This is a summary of the European public assessment report (EPAR) for Aldurazyme. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aldurazyme.
Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
A16AB05
ATC Item
N/A
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| laronidase | N/A | laronidase |
EMA Name
Aldurazyme
Medicine Name
Aldurazyme
Aliases
N/ANo risk management plan link.
