Licensed vaccine

Cervarix

FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN BL 125259

Key facts

Trade name Cervarix
Proper name Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant
Manufacturer GlaxoSmithKline Biologicals
Submission tracking number (STN) BL 125259
FDA product areas Biologics
Recent FDA documents Approval History, Letters, Reviews, and Related Documents - Cervarix, Package Insert & Patient Information- Cervarix, Supporting Documents older than three years - Cervarix
FDA page updated Oct 25, 2019
FDA product page fda.gov

At a glance

  • None FDA approval letters
  • 1–9 Supporting documents
  • 1–9 Product information documents
  • Yes Document full text searchable in Orca1

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-licensed vaccines

The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.

Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date:

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