FDA — authorised 3 December 2002
- Application: NDA021511
- Marketing authorisation holder: ROCHE
- Local brand name: COPEGUS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 COPE in United States
FDA authorised COPE on 3 December 2002
Marketing authorisations
FDA
- Status: approved
COPE 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 COPE approved in United States?
Yes. FDA authorised it on 3 December 2002; FDA has authorised it.
Who is the marketing authorisation holder for COPE in United States?
ROCHE holds the US marketing authorisation.