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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Compliance Check Email, May 22, 2012 - MenHibrix

From:                     Byrd, Sean (CBER)
Sent:                      Tuesday, May 22, 2012 9:58 AM
To:                         CBER Complicheck
Cc:                         Staten, David; Temenak, Joseph; Prutzman, Kirk C; Renshaw, Carolyn
Subject:                 Compliance Check, MenHibrix, STN 125363/0

Importance:            High

Manufacturing locations:
GlaxoSmithKline Biologicals, S. A. d/b/a GlaxoSmithKline
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
(Drug substance and drug product manufacturer)

 

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STN:   125363/0
 


Lic. #: 1617                           

Company/Address:
GlaxoSmithKline Biologicals S.A.
2301 Renaissance Blvd., Building 510
P.O. Box 61540
King of Prussia, PA  19406-2772
(U.S. representative)

Product: meningococcal and Hib TT conjugate vaccine

Subm Type:   BLA               

First Action Due Date: 31 August 2012 (NOTE:  Internal MANDATORY action due date is 15 June 2012)

Short Summary: 
active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b
and Neisseria meningitidis serogroups C and Y

Sean R. Byrd
Lieutenant Commander, USPHS
Director, Regulatory Review Officer
CBER/OCBQ/DMPQ
Office: 301-827-6951
Fax:  301-827-3536