Commitment COM-390
Post-approval commitment for MFDS-2020-0090. Category: Labeling Update. Priority: low.
Commitment ID
COM-390
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling Update
Priority
low
Status
In Progress
Due Date
2025-10-04
Completed At
—
Owner
Lieselotte van der Berg
Created
2023-07-06
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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