Post-approval commitment for SAHPRA-2022-0038. Category: Pharmacovigilance. Priority: high.

Commitment ID
COM-338
Application
Authority
South African Health Products Regulatory Authority
Category
Pharmacovigilance
Priority
high
Status
Open
Due Date
2025-11-18
Completed At
—
Owner
Sarah Chen
Created
2022-11-15
Description

Update SmPC section 4.4 with hepatic impairment data

Evidence (0)
No evidence documents attached. Upload evidence to mark this commitment as complete.