Commitment COM-160
Post-approval commitment for MOH-IL-2020-0060. Category: Paediatric Study. Priority: high.
Commitment ID
COM-160
Application
Authority
Israel Ministry of Health
Category
Paediatric Study
Priority
high
Status
Blocked
Due Date
2025-07-09
Completed At
—
Owner
Dmitri Volkov
Created
2023-04-24
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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