FDA — authorised 16 November 1992
- Marketing authorisation holder: BRACCO
- Status: approved
🇺🇸 Prohance in United States
FDA authorised Prohance on 16 November 1992
Marketing authorisations
FDA — authorised 16 November 1992
- Application: NDA020131
- Marketing authorisation holder: BRACCO
- Local brand name: PROHANCE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 October 2003
- Application: NDA021489
- Marketing authorisation holder: BRACCO
- Local brand name: PROHANCE MULTIPACK
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA218749
- Marketing authorisation holder: HAINAN POLY
- Local brand name: GADOTERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
Prohance in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Prohance approved in United States?
Yes. FDA authorised it on 16 November 1992; FDA authorised it on 16 November 1992; FDA authorised it on 9 October 2003.
Who is the marketing authorisation holder for Prohance in United States?
BRACCO holds the US marketing authorisation.