CALQUENCE (AstraZeneca Pty Ltd)
Product name
CALQUENCE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
73 working days (175)
Active ingredients
acalabrutinib
Registration type
NCE/NBE
Indication
CALQUENCE (capsules) is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration