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FVP-P-71

Euvax B
Hepatitis B vaccine (recombinant)
Product Details
WHO Product ID
FVP-P-71
Status
Prequalified
Date of prequalification
Vaccine type
Hepatitis B vaccine (recombinant)
Abbreviated Name
HepB
Commercial Name
Euvax B
PQ Holder
LG Chem Ltd (LGC)
LG Twin Towers 128 Yeoui-daero Yeongdeungpo-gu
Seoul,
7336
Republic of Korea
Responsible NRA
Ministry of Food and Drug Safety (MFDS)
Product description
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
10
Route of administration
Intramuscular
Vaccine Vial Monitor
Type 30
Multidose Vial Policy
WHO recommends that opened vials of this vaccine may be used in subsequent immunization sessions (up to 28 days) if the conditions outlined in the WHO Policy Statement are met.
Shelf life (months)
36 months
Storage temperature
2 - 8°C
Diluent
N/A
Preservative
Thiomersal
Preservative concentration
0.01%
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
10
Description
Carton of 10 vials (100 paediatric doses) [Dimensions: 11.5 x 4.7 x 5.3 cm].
Dimensions
11.5 x 4.7 x 5.3 cm
Cold Chain Volume (cm³/dose)
2.86
Component Packed
Active (Vaccine)
Total doses
10
Description
Carton of 10 vials (100 adult doses) [Dimensions: 13.5x5.4x6.7 cm]
Dimensions
13.5 x 5.4 x 6.7 cm
Cold Chain Volume (cm³/dose)
4.88
Attachments
Package Insert-pq_72_HepB_10doses_LG_PI-2020_UNICEF
Package Insert-pq_72_HepB_10doses_LG_PI-2020_PAHO