Commitment COM-299
Post-approval commitment for Roszdravnadzor-2021-0099. Category: Labeling Update. Priority: high.
Commitment ID
COM-299
Application
Authority
Ministry of Health of Russia
Category
Labeling Update
Priority
high
Status
In Progress
Due Date
2025-06-21
Completed At
—
Owner
Tomoko Ikeda
Created
2023-02-12
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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