WHO recommendation AstraZeneca/EU approved sites COVID-19 Vaccine (ChAdOx1-S) [recombinant])
Product Overview |
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| Vaccine type: | COVID-19 Vaccine (ChAdOx1-S ([recombinant]) | ||
| Commercial name: | Vaxzevria | ||
| EUL holder: | AstraZeneca AB | ||
| Country: | Sweden | ||
| URL: | https://www.astrazeneca.com | ||
| Manufacturing sites: | See box below "Manufacturing sites" | ||
| Responsible NRA: | European Medicines Agency | ||
| Country: | The Netherlands | ||
| URL: | |||
WHO Recommendation |
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| Effective date: | 15 April 2021 | ||
Product Description |
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| Pharmaceutical form: | Suspension for injection | ||
| Presentation: | Vial | ||
| Number of doses: | 8 doses and 10 doses | ||
| Diluent: | Not applicable | ||
| Route of administration | Intramuscular | ||
| Age indication: | Individuals ≥18 years old | ||
| Shelf-life: | 6 months | at storage temperature: | 2°C to 8°C |
| Vaccine vial monitor: | None | ||
| Secondary packaging: |
1) Carton of ten 5mL vials (80 doses). Dimensions: 8.1 x 4.1 x 10.6 cm. 2) Carton of ten 10R vials (100 doses). Dimensions: 13.5 x 5.5 x 5.5 cm. 3) Carton of ten 6mL vials (100 doses). Dimensions: 14.5 x 6.8 x 5.1 cm. 4) Carton of ten 5mL vials (100 doses). Dimensions: 13.2 x 5.7 x 5.0 cm. |
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| Tertiary packaging: |
1) 24 secondary packaged cartons containing 10 vials per carton. (240 vials /1920 doses). Dimensions: 26.2 x 22.8 x 18.8 cm 2) 16 secondary packaged cartons containing 10 vials per carton. (160 vials /1600 doses). Dimensions: 29.0 x 25.0 x 13.1 cm 3) 24 secondary packaged cartons containing 10 vials per carton. (240 vials /2400 doses). Dimensions: 31.0 x 21.8 x 22.8 cm 4) 24 secondary packaged cartons containing 10 vials per carton. (240 vials /2400 doses). Dimensions: 24.8 x 28.8 x 18.0 cm |
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| Cold chain volume: |
1) 4.40 2) 4.08 3) 5.03 4) 3.76 |
cm3 (in secondary packaging) | |
| Preservative: | Not applicable | with concentration: | Not applicable |
| Handling of opened multidose-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. |
MANUFACTURING SITES
Drug Substance:
- Henogen S.A.
Rue de la Marlette 14
7180 Seneffe
Belgium
- Catalent Maryland, Inc
7555 Harmans Road Harmans
MD 21077
United States
- Oxford Biomedica (UK) Ltd
Unit A Plot 7000 Alec Issigonis Way
Oxford OX4 2ZY
United Kingdom
- Halix B.V.
Tinbergenweg 1
2333 BB Leiden
Netherlands
- WuXi Biologics
108 Meiliang Road
Mashan, Binhu District
WuXi, Jiangsu 214092
China
Drug Product:
- Amylin Ohio LLC (AZ)
8814 Trade Port Drive
West Chester
Ohio 45071
United States of America
- Catalent Anagni
Località Fontana del Ceraso
S.P. Casilina
41 03012 Anagni (FR)
Italy
- CP Pharmaceuticals
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
- IDT Biologika
Am Pharmapark
Dessau-Rosslau 06861
Germany
- Universal Farma, S.L. (“Chemo”)
C/Del Tejido, 2, Azugueca de Henares
Guadalajara, 19200
Spain