Vaxzevria



Product Overview


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


INN:                           N/A


Trade name:             Vaxzevria


EUL holder:               AstraZeneca AB


Country:                    Sweden


Responsible NRA:     

       Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

       National Administration of Medicines, Food and Medical Technology (ANMAT)


Country:                     Mexico and Argentina


 

WHO EUL Recommendation


Effective date:            23 December 2021


 

Product description


Pharmaceutical Form:                   Suspension for injection                                    


Presentation:                                   6 mL vial


Number of doses:                            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 vials (100 doses). Dimensions: 13.9 x 5.4 x 6.1 cm

Tertiary Packaging: 

 a. 24 secondary packaged cartons (1240 vials/2400 doses). Dimensions: 28.5 x 23.3 x 19.9 cm

Cold Chain Volume in

secondary packaging:

 a. 4.6 cm3/dose

 

Product Characteristics and Package Leaflet