PMDA
- Application: Ongentys
- Local brand name: Ongentys
- Status: approved
Ongentys (Ongentys) regulatory status in Japan.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. PMDA has authorised it.
Bial - Portela C S.A. is the originator. The local marketing authorisation holder may differ — check the official source linked above.