Vaccines, Blood & Biologics
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
