PMDA — authorised 27 September 2017
- Marketing authorisation holder: Janssen Pharmaceutical KK
- Status: approved
🇯🇵 Darzalex in Japan
PMDA authorised Darzalex on 27 September 2017
Marketing authorisation
Darzalex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in Japan
Frequently asked questions
Is Darzalex approved in Japan?
Yes. PMDA authorised it on 27 September 2017.
Who is the marketing authorisation holder for Darzalex in Japan?
Janssen Pharmaceutical KK holds the Japanese marketing authorisation.