PMDA
- Application: Intuniv Partial Change Approval
- Local brand name: Intuniv Partial Change Approval
- Status: approved
🇯🇵 SPD503 (1 mg) in Japan
SPD503 (1 mg) (SPD503 (1 mg)) regulatory status in Japan.
Marketing authorisation
Frequently asked questions
Is SPD503 (1 mg) approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for SPD503 (1 mg) in Japan?
Shire is the originator. The local marketing authorisation holder may differ — check the official source linked above.