FDA — authorised 23 November 2004
- Application: BLA125104
- Marketing authorisation holder: BIOGEN IDEC
- Local brand name: TYSABRI
- Indication: VIAL — SINGLE-USE
- Status: approved
🇺🇸 BG00002 in United States
FDA authorised BG00002 on 23 November 2004
Marketing authorisations
FDA
- Status: approved
BG00002 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is BG00002 approved in United States?
Yes. FDA authorised it on 23 November 2004; FDA has authorised it.
Who is the marketing authorisation holder for BG00002 in United States?
BIOGEN IDEC holds the US marketing authorisation.