FDA — authorised 27 April 2017
- Marketing authorisation holder: BIOMARIN PHARM
- Status: approved
FDA authorised Rhttp1 on 27 April 2017
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 27 April 2017.
BIOMARIN PHARM holds the US marketing authorisation.