FDA — authorised 13 May 2005
- Application: BLA103964
- Marketing authorisation holder: Pharmaand GmbH
- Indication: Labeling
- Status: approved
FDA authorised Peginterferon on 13 May 2005
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 13 May 2005; FDA authorised it on 22 December 2015.
Pharmaand GmbH holds the US marketing authorisation.