FDA — authorised 14 November 2007
- Application: BLA125164
- Marketing authorisation holder: HOFFMAN-LA ROCHE
- Local brand name: MIRCERA
- Indication: SOLUTION — INJECTION
- Status: approved
🇺🇸 RO0503821 (1x/4 Weeks) in United States
FDA authorised RO0503821 (1x/4 Weeks) on 14 November 2007
Marketing authorisation
Other Immunology approved in United States
Frequently asked questions
Is RO0503821 (1x/4 Weeks) approved in United States?
Yes. FDA authorised it on 14 November 2007.
Who is the marketing authorisation holder for RO0503821 (1x/4 Weeks) in United States?
HOFFMAN-LA ROCHE holds the US marketing authorisation.