JEEV® (6µg)
Japanese encephalitis vaccine (inactivated) for human use
Product Details
WHO Product ID
FVP-P-263
Status
Prequalified
Date of prequalification
Vaccine type
Japanese encephalitis vaccine (inactivated) for human use
Abbreviated Name
JE
Commercial Name
JEEV® (6µg)
PQ Holder
India
NRA of record
Central Drugs Standard Control Organization
Product description
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
1
Route of administration
Intramuscular
Vaccine Vial Monitor
Type 14
Shelf-life
36 months
Storage temperature
2 - 8°C
Diluent
N/A
Preservative
None
Multidose Vial Policy
Not applicable
Remarks
June 2014: based on review of stability data a change in shelf life from 24 to 36 months at 2-8°C and a change from VVM type 7 to VVM type 14 was approved.June 2014: Updated product insert and VPSAR refer to additional indication for 12-35 month old infants. In that age range the dose is 0.25mL. For paediatric use this presentation of the vaccine (6 mcg/0.5mL) îs a two-dose preservative free presentation and the issues of programmatic readiness for use of that presentation are described in the VPSAR. In July 2016 a single dose vial presentation of a formulation (3 mcg/0.5mL dose) was prequalified for paediatric use. [link above in "other presentations of this vaccine"]
Product Packaging
Secondary Container
Shipping Container
Component Packed
Active (Vaccine)
Total doses
48
Description
Carton of 48 vials (14.5 x 10.8 x 4.5 cm)
Cold Chain Volume (cm³/dose)
0.0
