Vaxzevria



Product Overview


Type:                         COVID-19 Vaccine (ChAdOx1-S ([recombinant])


INN:                           N/A


Trade name:             Vaxzevria


EUL holder:               AstraZeneca AB


Country:                    Sweden


Responsible NRA:    European Medicines Agency (EMA)


Country:                     The Netherlands


 

WHO EUL recommendation


Effective date:            15 April 2021


 

Product description


Pharmaceutical Form:                   Suspension for injection                                    


Presentation:                                   5 mL vial and 6 mL vial


Number of doses:                            8 doses (0.5 mL per dose) and 10 doses (0.5 mL per dose)


Route of administration:                Intramuscular


Age indication:                                18 years and older


Shelf – life:                                       6 months     Storage temperature:   2°C to 8°C      


Vaccine Vial monitor (VVM):        None


Preservative:                                    None


Adjuvant:                                           None


Diluent:                                               None


Handling of opened multi-dose vials: 

WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.


 

Packaging description

Secondary Packaging: 

 a. Carton of ten 5mL vials (80 doses). Dimensions: 8.1 x 4.1 x 10.6 cm.

 b. Carton of ten 10R vials (100 doses). Dimensions: 13.5 x 5.5 x 5.5 cm.

 c. Carton of ten 6mL vials (100 doses). Dimensions: 14.5 x 6.8 x 5.1 cm.

 d. Carton of ten 5mL vials (100 doses). Dimensions: 13.2 x 5.7 x 5.0 cm.

Tertiary Packaging: 

 a. 24 secondary packaged cartons containing 10 vials per carton (240 vials /1920 doses)  

     Dimensions: 26.2 x 22.8 x 18.8 cm

 b. 16 secondary packaged cartons containing 10 vials per carton (160 vials /1600 doses) 

     Dimensions: 29.0 x 25.0 x 13.1 cm

 c. 24 secondary packaged cartons containing 10 vials per carton (240 vials /2400 doses)

     Dimensions: 31.0 x 21.8 x 22.8 cm

 d. 24 secondary packaged cartons containing 10 vials per carton (240 vials /2400 doses)

     Dimensions: 24.8 x 28.8 x 18.0 cm

Cold Chain Volume in

secondary packaging:

 a. 4.40 cm3/dose      

 b. 4.08 cm3/dose      

 c. 5.03 cm3/dose      

 d. 3.76 cm3/dose      

 

Product Characteristics and Package Leaflet