FDA — authorised 20 March 2013
- Marketing authorisation holder: GUERBET
- Status: approved
🇺🇸 Dotarem in United States
FDA authorised Dotarem on 20 March 2013
Marketing authorisations
FDA — authorised 20 March 2013
- Application: NDA204781
- Marketing authorisation holder: GUERBET
- Local brand name: DOTAREM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 April 2022
- Application: ANDA215304
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: GADOTERATE MEGLUMINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Dotarem 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 Dotarem approved in United States?
Yes. FDA authorised it on 20 March 2013; FDA authorised it on 20 March 2013; FDA authorised it on 11 April 2022.
Who is the marketing authorisation holder for Dotarem in United States?
GUERBET holds the US marketing authorisation.