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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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April 1, 2009 Approval Letter - Fluarix

Our STN: BL 125127/314

April 1, 2009

GlaxoSmithKline Biologicals
Attn: Mary Beth Ebert, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Ebert:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Fluarix®, to include a thimerosal-free formulation in single-dose prefilled syringes and related changes in the labeling.

Please submit all final printed labeling and implementation information of all labeling items that were provided in your August 28, 2008, submission on FDA Form 356h.  Please provide a PDF-format electronic version of the label.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--- signature ---

Jerry Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling


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