PMDA — authorised 18 June 2019
- Marketing authorisation holder: Nippon Shinyaku Co., Ltd.
- Status: approved
PMDA authorised Defitelio on 18 June 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. PMDA authorised it on 18 June 2019.
Nippon Shinyaku Co., Ltd. holds the Japanese marketing authorisation.