FDA
- Status: approved
Usual routine care (Usual routine care) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the originator. The local marketing authorisation holder may differ — check the official source linked above.