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Qdenga®

Product overview

Vaccine type
Dengue Tetravalent (live, attenuated)
Commercial Name
Qdenga
Manufacturer
Takeda GmbH.
Manufacturer Country
Germany
Responsible NRA
European Medicines Agency
Country
Netherlands

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
1
Diluent
0.22% sodium chloride
Route of Administration
Subcutaneous
Shelf Life
18 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 2
Secondary Packaging
Box containing 10 single-dose vials of vaccine + 10 single-dose vials of diluent (10 doses). Dimensions: 4.6 x 7.25 x 9.65 cm.
Tertiary Packaging
Box containing 54 secondary boxes (540 doses). Dimensions: 31.2 x 25.5 x 30.8 cm.
Multidose Vial Policy
Not applicable
Vaccine Preservative
none
Cold Chain Volume
16.09 cm3/dose (in secondary packaging)

Attachments

Package Insert
SmPC
WHO Public Assessment Report - WHOPAR