FDA — authorised 15 November 2017
- Marketing authorisation holder: ULTRAGENYX PHARM INC
- Status: approved
🇺🇸 Mepsevii in United States
FDA authorised Mepsevii on 15 November 2017
Marketing authorisations
FDA — authorised 15 November 2017
- Application: BLA761047
- Marketing authorisation holder: ULTRAGENYX PHARM INC
- Local brand name: MEPSEVII
- Indication: INJECTABLE — INJECTION
- Status: approved
Mepsevii in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Mepsevii approved in United States?
Yes. FDA authorised it on 15 November 2017; FDA authorised it on 15 November 2017.
Who is the marketing authorisation holder for Mepsevii in United States?
ULTRAGENYX PHARM INC holds the US marketing authorisation.