PMDA — authorised 23 July 2010
- Marketing authorisation holder: Bayer Yakuhin
- Status: approved
PMDA authorised Ortho-Novum 10/11-21 on 23 July 2010
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. PMDA authorised it on 23 July 2010.
Bayer Yakuhin holds the Japanese marketing authorisation.