Commitment COM-295
Post-approval commitment for ANMAT-2020-0095. Category: Labeling Update. Priority: medium.
Commitment ID
COM-295
Application
Authority
ANMAT
Category
Labeling Update
Priority
medium
Status
Blocked
Due Date
2025-09-21
Completed At
—
Owner
Carlos Mendez
Created
2022-12-08
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
No evidence documents attached. Upload evidence to mark this commitment as complete.