Product Information

• Package Insert - Twinrix (PDF - 151KB)

Supporting Documents

• July 16, 2012 Approval Letter - Twinrix
  Updated information regarding instruction on the method of vaccine administration to the Dosage and Administration section of the package insert.
• April 12, 2012 Approval Letter - TWINRIX
  To revise the package insert to add the text "immediate injection site pain, stinging, and burning sensation" to the Postmarketing Experience Section.
• March 12, 2012 Approval Letter - Twinrix
  To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
• September 23, 2011 Approval Letter - Twinrix
  To rivise the package insert to comply with the Physician Labeling Rule.
• September 3, 2010 Approval Letter - Twinrix
  Updated the package insert to include the appropriate warnings regarding latex containing components.
• December 2, 2009 Approval Letter - Twinrix
  Updating the Package Insert to include additional adverse events.
• September 16, 2009 Approval Letter - Twinrix
  Changes to the package insert regarding the possibility of cracked vials or syringes.
• March 28, 2007 Approval Letter - Twinrix
  Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus.
• May 11, 2001 Approval Letter - Twinrix
  For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose.

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