Product overview
Type
Varicella
Commercial Name
SKYVaricella Inj.
Manufacturer
SK Bioscience Co., Ltd.
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
Two vial set (active + excipient)
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 5 vaccine vials + 5 diluent vials (5 doses)[Dimensions: 4.55 x 3.65 x 8.85 cm]; b) Carton of 10 vaccine vials (10 doses) + separate carton of 10 diluent vials (10 dose) [Dimensions: 4.55 x 3.65 x 8.85 cm]
Tertiary Packaging
a) Box containing 170 cartons of 5 vaccine vials + 5 diluent vials (1700 vials/ 850 doses)[Dimensions: 64.5 x 74.5 x 68.5]; b) Box containing 85 cartons of 10 vaccine vials + 85 cartons of diluent vials (1700 vials/ 850 doses)[Dimensions: 64.5 x 74.5 x 68.5 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
a) and b) 14.7 cm3/dose (in secondary packaging)
Attachments