TGA
- Status: approved
Open-label, PK Cohort (Cohort B): ponsegromab low dose (open-label-pk-cohort-cohort-b-ponsegromab-low-dose) regulatory status in Australia.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. TGA has authorised it.
Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.