EMA — authorised 3 August 2001
- Marketing authorisation holder: SANOFI B.V.
- Status: approved
🇪🇺 Fabrazyme in European Union
EMA authorised Fabrazyme on 3 August 2001
Marketing authorisation
Fabrazyme 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 approved in European Union?
Yes. EMA authorised it on 3 August 2001.
Who is the marketing authorisation holder for Fabrazyme in European Union?
SANOFI B.V. holds the EU marketing authorisation.