FDA — authorised 23 May 1994
- Application: BLA020367
- Marketing authorisation holder: GENZYME
- Local brand name: CEREZYME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Cerezyme® on 23 May 1994
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 23 May 1994.
GENZYME holds the US marketing authorisation.