This is a summary of the European public assessment report (EPAR) for Zavesca. 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 Zavesca.
Therapeutic Indication
### Therapeutic indication Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.
Therapeutic Area (MeSH)
ATC Code
A16AX06
ATC Item
miglustat
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| miglustat | N/A | 麦格司他 |
EMA Name
Zavesca
Medicine Name
Zavesca
Aliases
N/ANo risk management plan link.
