EMA — authorised 8 January 2007
- Marketing authorisation holder: Shire Human Genetic Therapies AB
- Status: approved
🇪🇺 Elaprase in European Union
EMA authorised Elaprase on 8 January 2007
Marketing authorisation
Elaprase 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 Elaprase approved in European Union?
Yes. EMA authorised it on 8 January 2007.
Who is the marketing authorisation holder for Elaprase in European Union?
Shire Human Genetic Therapies AB holds the EU marketing authorisation.