Product Approval Information
Proper Name: Immune Globulin Intravenous, Human 5%
Tradename: OCTAGAM
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H., License #1646
Package Insert (PDF - 107 KB) - Approved: February 3, 2006
Date: February 3, 2006
Package Insert Revision: Include labeling changes to the "Warnings/Blood Glucose Testing" and "Precautions/Drug/Laboratory Test Interactions" sections of the package insert strengthening the warning of effects of maltose in the product
February 3, 2006 Approval Letter
Date: May 21, 2004
Indication: Treatment of primary immune deficient diseases
May 21, 2004 Approval Letter
Summary Basis of Approval (PDF - 102 KB)