PMDA
- Application: Spinraza Initial Approval
- Local brand name: Spinraza Initial Approval
- Status: approved
🇯🇵 NUSINERSEN SODIUM in Japan
NUSINERSEN SODIUM (NUSINERSEN SODIUM) regulatory status in Japan.
Marketing authorisations
PMDA
- Application: Spinraza Partial Change Approval
- Local brand name: Spinraza Partial Change Approval
- Status: approved
NUSINERSEN SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is NUSINERSEN SODIUM approved in Japan?
Yes. PMDA has authorised it; PMDA has authorised it.
Who is the marketing authorisation holder for NUSINERSEN SODIUM in Japan?
Marketing authorisation holder not available in our data.