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Dengvaxia

Product overview

Type
Dengue Tetravalent (live, attenuated)
Commercial Name
Dengvaxia
Manufacturer
Sanofi Pasteur
Responsible NRA
Agence nationale de sécurité du médicament et des produits de santé
Country
France

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Two vial set (active + excipient)
Number of Doses
5
Diluent
0.9% Sodium Chloride
Route of Administration
Subcutaneous
Shelf Life
36 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 14
Secondary Packaging
Carton of 5 vials (25 dose)[Dimensions: 77 x 35 x 48.5 cm]
Tertiary Packaging
Box containing 80 cartons of 5 vials (400 vials/2000 doses)[Dimensions: 393 x 147 x 207 cm]
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.
Vaccine Preservative
none
Cold Chain Volume
5.22 cm3/dose (in secondary packaging)

Attachments

Package Insert