PMDA — authorised 28 September 2012
- Marketing authorisation holder: Novo Nordisk Pharma Ltd
- Status: approved
🇯🇵 Tresiba in Japan
PMDA authorised Tresiba on 28 September 2012
Marketing authorisation
Tresiba in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in Japan
Frequently asked questions
Is Tresiba approved in Japan?
Yes. PMDA authorised it on 28 September 2012.
Who is the marketing authorisation holder for Tresiba in Japan?
Novo Nordisk Pharma Ltd holds the Japanese marketing authorisation.