EMA — authorised 12 May 2016
- Marketing authorisation holder: Swedish Orphan Biovitrum AB
- Status: approved
EMA authorised Alprolix on 12 May 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 12 May 2016.
Swedish Orphan Biovitrum AB holds the EU marketing authorisation.