FDA — authorised 14 February 2014
- Marketing authorisation holder: BIOMARIN PHARM
- Status: approved
🇺🇸 Rhgalns in United States
FDA authorised Rhgalns on 14 February 2014
Marketing authorisations
FDA — authorised 14 February 2014
- Application: BLA125460
- Marketing authorisation holder: BIOMARIN PHARM
- Local brand name: VIMIZIM
- Indication: INJECTABLE — INJECTION
- Status: approved
Rhgalns 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 Rhgalns approved in United States?
Yes. FDA authorised it on 14 February 2014; FDA authorised it on 14 February 2014.
Who is the marketing authorisation holder for Rhgalns in United States?
BIOMARIN PHARM holds the US marketing authorisation.