FDA — authorised 24 July 2006
- Application: BLA125151
- Marketing authorisation holder: SHIRE
- Local brand name: ELAPRASE
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
🇺🇸 Elaprase in United States
FDA authorised Elaprase on 24 July 2006
Marketing authorisations
FDA
- Status: approved
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 United States
Frequently asked questions
Is Elaprase approved in United States?
Yes. FDA authorised it on 24 July 2006; FDA has authorised it.
Who is the marketing authorisation holder for Elaprase in United States?
SHIRE holds the US marketing authorisation.