🇯🇵 Qalsody in Japan

Qalsody (TOFERSEN) regulatory status in Japan.

Marketing authorisation

Qalsody in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Rare Disease approved in Japan

Frequently asked questions

Is Qalsody approved in Japan?

Yes. PMDA has authorised it.

Who is the marketing authorisation holder for Qalsody in Japan?

Biogen Ma is the originator. The local marketing authorisation holder may differ — check the official source linked above.