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Product Approval Information - Licensing Action

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Proper name: Respiratory Syncytial Virus Immune Globulin Intravenous (Human)
Tradename: Respigam
Manufacturer: Massachusetts Public Health Biologic Laboratories, Boston, MA, License #0064
Indication for Use: Prevention of serious lower respiratory tract infection caused by Respiratory Syncytial Virus in children less than 24 months of age with bronchopulmonary dysplasia or a history of prematurity (less than or equal to 35 weeks gestation)
Approval Date: 1/18/96
Type of submission: Product license application

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Approval Letter - (PDF), (Text)

 

Updated March 6, 2001
 
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