Commitment COM-111
Post-approval commitment for TFDA-2024-0011. Category: Labeling Update. Priority: high.
Commitment ID
COM-111
Application
Authority
Taiwan Food and Drug Administration
Category
Labeling Update
Priority
high
Status
Overdue
Due Date
2025-09-11
Completed At
—
Owner
Lieselotte van der Berg
Created
2023-04-03
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
No evidence documents attached. Upload evidence to mark this commitment as complete.