🇪🇺 glucosidase alfa in European Union

EMA authorised glucosidase alfa on 28 March 2006

Marketing authorisation

EMA — authorised 28 March 2006

  • Application: EMEA/H/C/000636
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Myozyme
  • Indication: Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-?-glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.
  • Status: approved

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glucosidase alfa in other countries

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

Frequently asked questions

Is glucosidase alfa approved in European Union?

Yes. EMA authorised it on 28 March 2006.

Who is the marketing authorisation holder for glucosidase alfa in European Union?

Sanofi B.V. holds the EU marketing authorisation.