Commitment COM-081
Post-approval commitment for FDA-2024-0081. Category: REMS. Priority: medium.
Commitment ID
COM-081
Application
Authority
Food and Drug Administration
Category
REMS
Priority
medium
Status
Blocked
Due Date
2025-08-14
Completed At
—
Owner
Tomoko Ikeda
Created
2022-07-24
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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