Commitment COM-331
Post-approval commitment for TFDA-2024-0031. Category: Manufacturing. Priority: high.
Commitment ID
COM-331
Application
Authority
Taiwan Food and Drug Administration
Category
Manufacturing
Priority
high
Status
Open
Due Date
2025-10-23
Completed At
—
Owner
Carlos Mendez
Created
2023-08-20
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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