EMA — authorised 5 November 2020
- Marketing authorisation holder: AstraZeneca AB
- Status: approved
EMA authorised Calquence on 5 November 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 5 November 2020.
AstraZeneca AB holds the EU marketing authorisation.