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Vaccines, Blood & Biologics
Hiberix
Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Tradename: Hiberix
Manufacturer: GlaxoSmithKline Biologicals, S.A.
Indication:
- For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b when administered as a booster dose in children 15 months through 4 years of age (prior to fifth birthday).
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Supporting Documents
- August 19, 2009 Approval Letter - Hiberix
For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b when administered as a booster dose in children 15 months through 4 years of age (prior to fifth birthday). - Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply
Press Release: August 19, 2009 - Approval History, Letters, Reviews, and Related Documents - Hiberix
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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