Cervarix
Recombinant human papillomavirus virus-like particle vaccine (types 16,18)
Product Details
WHO Product ID
FVP-P-180
Status
Prequalified
Date of prequalification
Vaccine type
Recombinant human papillomavirus virus-like particle vaccine (types 16,18)
Abbreviated Name
HPV
Commercial Name
Cervarix
PQ Holder
GlaxoSmithKline Biologicals SA
20 Avenue Fleming 1300 Wavre Belgium
Wavre,
B-1300
Belgium
Responsible NRA
Federal Agency for Medicines and Health Products (FAMPH)
Product description
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
2
Route of administration
Intramuscular
Vaccine Vial Monitor
Type 30
Multidose Vial Policy
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Shelf life (months)
60 months
Storage temperature
2 - 8°C
Diluent
N/A
Preservative
None
Remarks
July 2014: Product Insert updated to include a two dose schedule for recipients aged 9-14 yearsA two dose preservative-free liquid presentation is a novel presentation for UN supported EPI programmes. Web statement on two-dose presentation of preservative-free Human Papilloma Vaccine from GlaxoSmithKline (GSK) (Cervarix™) attached.
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
1
Description
Carton of 1 vial [Dimensions 3.1x3.1x
Dimensions
3.1 x 3.1 cm
Cold Chain Volume (cm³/dose)
0.0
Component Packed
Active (Vaccine)
Total doses
1
Description
Carton of 10 vials [Dimensions 8.4x3.7x3.7 cm]
Dimensions
8.4 x 3.7 x 3.7 cm
Cold Chain Volume (cm³/dose)
5.75
Component Packed
Active (Vaccine)
Total doses
1
Description
Carton of 100 vials [Dimensions 17.8x14.7x3.7]
Dimensions
17.8 x 14.7 x 3.7 cm
Cold Chain Volume (cm³/dose)
4.84
