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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

OVRR Lot Clearance Request Email, May 09, 2012 - MenHibrix

From: Staten, David
Sent: Wednesday, May 09, 2012 2:23 PM
To: CBER Lot Clearance
Cc: Temenak, Joseph; Prutzman, Kirk C
Subject: OVRR Lot Clearance request STN 125363/0

-b(4)- lots were submitted on December 21, 2011 (---b(4)------------------------------). At the time of approval there will not be any launch lots. The sponsor estimates that the launch lots and reagents will available toward the end of July.

Please confirm that there are no lots associated with this Supplement.

STN: 125363/0

Lic. #: 1617

Company/Address :

GlaxoSmithKline Biologicals, S. A. d/b/a GlaxoSmithKline
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM

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Product: meningococcal and Hib TT conjugate vaccine

Subm Type: BLA

First Action Due Date: June 1, 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

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THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.

David Schwab, MSIS
LT, USPHS
Food and Drug Administration
Office of Vaccines Research and Review
office (301)-796-1788
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