FDA — authorised 8 January 1993
- Marketing authorisation holder: GE HEALTHCARE
- Status: approved
🇺🇸 Omniscan in United States
FDA authorised Omniscan on 8 January 1993
Marketing authorisations
FDA — authorised 8 January 1993
- Application: NDA020123
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: OMNISCAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 September 2007
- Application: NDA022066
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: OMNISCAN
- Indication: INJECTABLE — INJECTION
- Status: approved
Omniscan 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 Omniscan approved in United States?
Yes. FDA authorised it on 8 January 1993; FDA authorised it on 8 January 1993; FDA authorised it on 5 September 2007.
Who is the marketing authorisation holder for Omniscan in United States?
GE HEALTHCARE holds the US marketing authorisation.