This is a summary of the European public assessment report (EPAR) for Cerezyme. 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 Cerezyme.
Therapeutic Indication
### Therapeutic indication Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: - anaemia after exclusion of other causes, such as iron deficiency - Thrombocytopenia - Bone disease after exclusion of other causes such as Vitamin D deficiency - hepatomegaly or splenomegaly
Therapeutic Area (MeSH)
ATC Code
A16AB02
ATC Item
imiglucerase
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| imiglucerase | N/A | 伊米苷酶 |
EMA Name
Cerezyme
Medicine Name
Cerezyme
Aliases
N/ANo risk management plan link.
