PMDA — authorised 20 September 2019
- Marketing authorisation holder: BioMarin Pharmaceutical Japan K.K.
- Status: approved
PMDA authorised Rhttp1 on 20 September 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 20 September 2019.
BioMarin Pharmaceutical Japan K.K. holds the Japanese marketing authorisation.