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FVP-P-244

BIOPOLIO B1/3
Poliomyelitis vaccines (bivalent live, oral, innactivated, type 1, 3)
Product Details
WHO Product ID
FVP-P-244
Status
Prequalified
Date of prequalification
Vaccine type
Poliomyelitis vaccines (bivalent live, oral, innactivated, type 1, 3)
Abbreviated Name
bOPV
Commercial Name
BIOPOLIO B1/3
PQ Holder
Bharat Biotech International Limited
Sy. No. 230 231 & 235 Genome Valley Turkapally Shamee
rpet Mandal Medchal-Malkajgiri District
Hyderabad,
Telangana
500 078
India
Responsible NRA
Central Drugs Standard Control Organization (CDSCO)
Product description
Bulk supplier
PT Bio Farma (Persero)
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
20
Route of administration
Oral
Vaccine Vial Monitor
Type 2
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)
24 months
Storage temperature
-20°C
Diluent
N/A
Preservative
None
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
25
Description
Carton of 25 vials (500 doses) [Dimensions: 11.0 x 11.0 x 3.5 cm]
Dimensions
11.0 x 11.0 x 3.5 cm
Cold Chain Volume (cm³/dose)
0.85
Attachments
VPSAR (Vaccine Public Summary Assessment Report)-pq_245_bOPV_bharat_vpsar
Package Insert-pq_316_245_bOPV1%263_Bharat_PI-2021