Commitment COM-257
Post-approval commitment for SFDA-2023-0057. Category: Paediatric Study. Priority: high.
Commitment ID
COM-257
Application
Authority
Saudi Food and Drug Authority
Category
Paediatric Study
Priority
high
Status
In Progress
Due Date
2024-11-16
Completed At
—
Owner
Marcus Webb
Created
2022-05-31
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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