Commitment COM-285
Post-approval commitment for ANVISA-2020-0085. Category: Post-Approval Study. Priority: medium.
Commitment ID
COM-285
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Post-Approval Study
Priority
medium
Status
Blocked
Due Date
2025-09-25
Completed At
—
Owner
Dmitri Volkov
Created
2023-04-03
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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