FDA — authorised 1 November 2019
- Application: ANDA210016
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: CLARISCAN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Clariscan in United States
FDA authorised Clariscan on 1 November 2019
Marketing authorisations
FDA
- Status: approved
Clariscan 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 Clariscan approved in United States?
Yes. FDA authorised it on 1 November 2019; FDA has authorised it.
Who is the marketing authorisation holder for Clariscan in United States?
GE HEALTHCARE holds the US marketing authorisation.