This is a summary of the European public assessment report (EPAR) for Replagal. 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 Replagal.
Therapeutic Indication
### Therapeutic indication Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
Therapeutic Area (MeSH)
ATC Code
A16AB03
ATC Item
agalsidase alfa
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| agalsidase alfa | N/A | 阿加糖酶α |
EMA Name
Replagal
Medicine Name
Replagal
Aliases
N/ANo risk management plan link.
