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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
Plastic Tube
Number of Doses
1
Diluent
Not Applicable
Route of Administration
Oral
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 7
Secondary Packaging
a) Carton of 1 tube [Dimensions: 5.3 x 8.7 x 2.5 cm]; b) Carton of 10 tubes [Dimensions: 12.8 x 8.7 x 2.5 cm]; c) Carton of 50 tubes [Dimensions: 14.6 x 8.5 x 6.9 cm]
Tertiary Packaging
a) Box of 220 cartons (220 doses) [Dimensions: 34.2 x 25.1 x 43.1 cm]; b) Box of 68 cartons (680 doses) [Dimensions: 34.2 x 25.1 x 43.1 cm]; c) Box of 30 cartons (1500 doses) [Dimensions: 34.2 x 25.1 x 43.1 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
a) 115.3 b) 43.3 c) 17.12 cm3/dose (in secondary packaging)

Attachments

General
Container Photo
General
Package Insert