Commitment COM-013
Post-approval commitment for CDSCO-2022-0013. Category: Post-Approval Study. Priority: high.
Commitment ID
COM-013
Application
Authority
Central Drugs Standard Control Organisation
Category
Post-Approval Study
Priority
high
Status
Overdue
Due Date
2024-12-30
Completed At
—
Owner
Sarah Chen
Created
2022-08-02
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
No evidence documents attached. Upload evidence to mark this commitment as complete.