Product overview
Type
Varicella
Commercial Name
BARYCELA inj.
Manufacturer
GC Biopharma Corp.
Responsible NRA
Ministry of Food and Drug Safety
Country
Republic of Korea
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Vial
Number of Doses
1
Diluent
Water for Injection
Route of Administration
Subcutaneous
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 7
Secondary Packaging
a. Carton of two vials/ 1 dose (vaccines and diluent) [Dimensions: 5.5 x 2.5 x 4.0 cm]; b. Carton of 20 vials/10 doses (vaccines and diluent/ 10 vials each) [Dimensions: 5.0 x 11.2 x 9.0 cm]
Tertiary Packaging
a. Box containing 640 secondary cartons with 1280 vials/ 640 doses (640 vials of vaccine and diluent each) [Dimensions: 28 x 29 x 55.5 cm]: b. Box containing 90 secondary cartons with 1800 vials/900 doses (900 vials of vaccine and dileunt each) [Dimensions: 28 x 29 x 55.5 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
a. 27.4 and b.25.2 cm3/dose (in secondary packaging)
Attachments
