🇪🇺 Fabrazyme (agalsidase beta) in European Union

Fabrazyme (agalsidase beta) (Fabrazyme (agalsidase beta)) regulatory status in European Union.

Marketing authorisation

EMA

  • Status: approved

Fabrazyme (agalsidase beta) in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Fabrazyme (agalsidase beta) approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Fabrazyme (agalsidase beta) in European Union?

Genzyme, a Sanofi Company is the originator. The local marketing authorisation holder may differ — check the official source linked above.