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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

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OCTAGAM

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)
Deviations of Form FDA 483 (PDF - 141 KB)
 

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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