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Rotarix

Product overview

Type
Rotavirus
Commercial Name
Rotarix
Manufacturer
GlaxoSmithKline Biologicals SA
Responsible NRA
Federal Agency for Medicines and Health Products
Country
Belgium

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Applicator
Number of Doses
1
Diluent
Not Applicable
Route of Administration
Oral
Shelf Life
36 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
none
Secondary Packaging
a) Carton of 1 blister with 1 oral applicator [Dimensions: 4.2 x 2.4 x 13.3 cm]; b) Carton of 2 blisters with 5 oral applicators (10 doses) [Dimensions: 13.0 x 4.1 x 16.0 cm]
Tertiary Packaging
a) Box of 200 cartons (200 doses) [Dimensions: 34.2 x 25.1 x 43.1 cm]; b) Box of 30 cartons (300 doses) [Dimensions: 34.2 x 25.1 x 43.1 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
a) 134 (on dose carton); b) 85.3 (10 doses carton) cm3/dose (in secondary packaging)

Attachments

Package Insert