FDA — authorised 8 January 2010
- Application: BLA125276
- Marketing authorisation holder: GENENTECH
- Local brand name: ACTEMRA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Tocilizumab Prefilled Syringe [Actemra] in United States
FDA authorised Tocilizumab Prefilled Syringe [Actemra] on 8 January 2010
Marketing authorisations
FDA — authorised 21 October 2013
- Application: BLA125472
- Marketing authorisation holder: GENENTECH
- Local brand name: ACTEMRA
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
Other Immunology approved in United States
Frequently asked questions
Is Tocilizumab Prefilled Syringe [Actemra] approved in United States?
Yes. FDA authorised it on 8 January 2010; FDA authorised it on 21 October 2013.
Who is the marketing authorisation holder for Tocilizumab Prefilled Syringe [Actemra] in United States?
GENENTECH holds the US marketing authorisation.