PMDA — authorised 21 September 2018
- Marketing authorisation holder: Kyowa Hakko Kirin Co., Ltd.
- Status: approved
PMDA authorised Carac on 21 September 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. PMDA authorised it on 21 September 2018.
Kyowa Hakko Kirin Co., Ltd. holds the Japanese marketing authorisation.