FDA — authorised 17 November 2022
- Application: BLA761183
- Marketing authorisation holder: PROVENTION BIO INC
- Local brand name: TZIELD
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised TZIELD on 17 November 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 November 2022; FDA has authorised it.
PROVENTION BIO INC holds the US marketing authorisation.