Vaccines, Blood & Biologics
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Kinrix
STN: BL 103907
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Tradename: KINRIX
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indication:
- Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose.
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Supporting Documents
July 16, 2012 Approval Letter - Kinrix
Updated information regarding instruction on the method of vaccine administration in the Dosage and Administration section of the package insert.March 12, 2012 Approval Letter - Kinrix
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information- January 20, 2011 Approval Letter - Kinrix
Revise the Package to address the presence of latex in the tip caps of the pre-filled syringes. May 19, 2010 Approval Letter - Kinrix
Revised the package insert to include a new presentation of a single-dose prefilled syringe that does not contain latex.October 8, 2009 Approval Letter - Kinrix
Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.June 24, 2008 Approval Letter - Kinrix
Indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series.Summary Basis for Regulatory Action - KINRIX Approval History, Letters, Reviews, and Related Documents - KINRIX
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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