FDA — authorised 27 August 2015
- Application: BLA125522
- Marketing authorisation holder: AMGEN INC
- Local brand name: REPATHA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Evolocumab Pre-filled Syringe in United States
FDA authorised Evolocumab Pre-filled Syringe on 27 August 2015
Marketing authorisation
Other Cardiovascular approved in United States
Frequently asked questions
Is Evolocumab Pre-filled Syringe approved in United States?
Yes. FDA authorised it on 27 August 2015.
Who is the marketing authorisation holder for Evolocumab Pre-filled Syringe in United States?
AMGEN INC holds the US marketing authorisation.