Commitment COM-381
Post-approval commitment for FDA-2024-0081. Category: Paediatric Study. Priority: low.
Commitment ID
COM-381
Application
Authority
Food and Drug Administration
Category
Paediatric Study
Priority
low
Status
Overdue
Due Date
2025-04-24
Completed At
—
Owner
Nadia Petrova
Created
2023-01-06
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
No evidence documents attached. Upload evidence to mark this commitment as complete.