Proper Name: Poliovirus Vaccine Inactivated (Monkey Kidney Cell)
Manufacturer: Sanofi Pasteur, SA, License #1724
- IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.
August 6, 2015 Approval Letter - IPOL(PDF - 41KB)
To include revisions to the package insert (PI) and other labeling items.
November 25, 2013 Approval Letter - IPOL
To modify the NDCs in the 2D barcode for the vial label and in the syringe label, modify the color to these labels and modify the package insert with the updated NDC numbers for this packaging in the “How Supplied” section.
October 19, 2012 Approval Letter - IPOL
To revise the package insert to include, the removal of in vivo chicken potency testing text in the Description section.
Summary for Basis of Approval - IPOL(PDF - 333KB)