PMDA
- Application: Sarclisa
- Local brand name: Sarclisa
- Status: approved
isatuximab SAR650984 IV (isatuximab SAR650984 IV) 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.
Sanofi is the originator. The local marketing authorisation holder may differ — check the official source linked above.