FDA — authorised 7 July 2008
- Application: BLA125164
- Marketing authorisation holder: HOFFMAN-LA ROCHE
- Indication: Labeling
- Status: approved
FDA authorised Neorecormon on 7 July 2008
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 7 July 2008.
HOFFMAN-LA ROCHE holds the US marketing authorisation.