Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Vaxzevria suspension for injection.
COVID-19 Vaccine (ChAdOx1-S [recombinant]).
| Pharmaceutical Form |
|---|
|
Suspension for injection (injection). The suspension is colourless to slightly brown, clear to slightly opaque with a pH of 6.6. |
These are multidose vials which contain 8 doses or 10 doses of 0.5 ml per vial (see section 6.5).
One dose (0.5 ml) contains: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)*, not less than 2.5 × 108 infectious units (Inf.U).
* Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology.
This product contains genetically modified organisms (GMOs).
Excipient with known effect: Each dose (0.5 ml) contains approximately 2 mg of ethanol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| SARS-CoV-2 Spike glycoprotein (ChAdOx1-S) |
SARS-CoV-2 Spike glycoprotein (ChAdOx1-S) is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. The SARS-CoV-2 S immunogen in the vaccine is expressed in the trimeric pre-fusion conformation; the coding sequence has not been modified in order to stabilise the expressed S-protein in the pre-fusion conformation. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralising antibody and cellular immune responses, which may contribute to protection to COVID-19. |
| List of Excipients |
|---|
|
L-Histidine |
8-dose vial: 4 mL of suspension in an 8-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 8 doses of 0.5 mL. Pack sizes of 10 multidose vials.
10-dose vial: 5 mL of suspension in a 10-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 10 doses of 0.5 mL. Pack sizes of 10 multidose vials.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/21/1529/001 10 multidose vials (8 doses per vial)
EU/1/21/1529/002 10 multidose vials (10 doses per vial)
Date of first authorisation: 29 January 2021
Date of latest renewal: 9 November 2021
| Drug | Countries | |
|---|---|---|
| VAXZEVRIA | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania |
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