Product Approval Information
Proper Name: Vaccinia Immune Globulin Intravenous (Human)
Tradename: None
Manufacturer: Cangene Corp, License #1201
Package Insert (PDF - 176 KB) - Approved: May 2, 2005
Date: May 2, 2005
Indication: treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination:
- Eczema vaccinatum
- Progressive vaccinia
- Severe generalized vaccinia
- Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
- Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
May 2, 2005 Approval Letter