PMDA — authorised 26 September 2022
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB K.K.
- Status: approved
PMDA authorised Sotyktu on 26 September 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. PMDA authorised it on 26 September 2022.
BRISTOL-MYERS SQUIBB K.K. holds the Japanese marketing authorisation.