PMDA
- Marketing authorisation holder: Kyorin Pharmaceutical Co., Ltd.
- Status: approved
SIMETRIDE (SIMETRIDE) 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.
Kyorin Pharmaceutical Co., Ltd. holds the Japanese marketing authorisation.