Cerezyme (imiglucerase)
- Region
- 🇪🇺 EU
- Active substance
- imiglucerase
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- CHMP opinion
- Wed 23 Jul 1997
- EU approval
- Mon 17 Nov 1997
- Application
- EMEA/H/C/000157
- ATC
- A16AB02
- Official record
- www.ema.europa.eu
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
Regulatory milestones
No milestones recorded in the last year.
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