🇪🇺 Cerezyme® in European Union

EMA authorised Cerezyme® on 17 November 1997

Marketing authorisation

EMA — authorised 17 November 1997

  • Application: EMEA/H/C/000157
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Cerezyme
  • 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
  • Status: approved

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Cerezyme® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Rare genetic disease / Lysosomal storage disorder approved in European Union

Frequently asked questions

Is Cerezyme® approved in European Union?

Yes. EMA authorised it on 17 November 1997.

Who is the marketing authorisation holder for Cerezyme® in European Union?

Sanofi B.V. holds the EU marketing authorisation.