Commitment COM-279
Post-approval commitment for Roszdravnadzor-2021-0079. Category: REMS. Priority: high.
Commitment ID
COM-279
Application
Authority
Ministry of Health of Russia
Category
REMS
Priority
high
Status
Blocked
Due Date
2025-06-26
Completed At
—
Owner
Carlos Mendez
Created
2022-10-28
Description
Update SmPC section 4.4 with hepatic impairment data
Evidence (0)
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