FDA — authorised 15 December 2004
- Marketing authorisation holder: BIOVITRUM AB
- Status: approved
🇺🇸 Kepivance in United States
FDA authorised Kepivance on 15 December 2004
Marketing authorisations
FDA — authorised 15 December 2004
- Application: BLA125103
- Marketing authorisation holder: BIOVITRUM AB
- Local brand name: KEPIVANCE
- Indication: INJECTABLE — INJECTION
- Status: approved
Kepivance in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Kepivance approved in United States?
Yes. FDA authorised it on 15 December 2004; FDA authorised it on 15 December 2004.
Who is the marketing authorisation holder for Kepivance in United States?
BIOVITRUM AB holds the US marketing authorisation.