FDA — authorised 23 May 1994
- Marketing authorisation holder: GENZYME
- Status: approved
🇺🇸 Cerezyme in United States
FDA authorised Cerezyme on 23 May 1994
Marketing authorisations
FDA — authorised 5 September 2014
- Application: BLA020367
- Marketing authorisation holder: GENZYME
- Indication: Manufacturing (CMC)
- Status: approved
Cerezyme in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Cerezyme approved in United States?
Yes. FDA authorised it on 23 May 1994; FDA authorised it on 5 September 2014.
Who is the marketing authorisation holder for Cerezyme in United States?
GENZYME holds the US marketing authorisation.