Post-approval commitment for HSA-2023-0092. Category: Post-Approval Study. Priority: high.

Commitment ID
COM-392
Application
Authority
Health Sciences Authority
Category
Post-Approval Study
Priority
high
Status
Open
Due Date
2025-11-20
Completed At
—
Owner
Nadia Petrova
Created
2023-06-18
Description

Update SmPC section 4.4 with hepatic impairment data

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