Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-10877 |
| Trade Name | Dose Form | Strength | Identifier |
| Vaxzevria | Solution for injection | 5x10^10 VP/0.5mL | |
| Sponsor | Application date | Registration situation | Classification |
| AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 29/1/2021 | Approval lapsed Approval date: 29/7/2021 Notification date: 29/11/2023 Labelling exemption expires 29/04/2024 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| ChAdOx1-S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 5.0 x 10^8 infectious units per mL) | CSL Behring (Australia) Pty Ltd 189-209 Camp Road, Broadmeadows VIC 3047 AUSTRALIA | |
| Oxford Biomedical (UK) Limited Unit A, Plot 7000 Alec Issigonis Way Oxford OX4 2ZY UNITED KINGDOM | ||
| Henogen SA Rue de la Marlette 14 Seneffe 7180 BELGIUM | ||
| Catalent Maryland Inc Main Building (BWI) 7555 Harmans Road Harmans 21077 UNITED STATES OF AMERICA | ||
| Excipient | ||
| Disodium edetate dihydrate | ||
| Ethanol | ||
| Histidine | ||
| Histidine hydrochloride monohydrate | ||
| Magnesium chloride hexahydrate | ||
| Polysorbate 80 | ||
| Sodium chloride | ||
| Sucrose | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 UNITED STATES OF AMERICA |
| Catalent Pharma Solutions LLC 160 Pharma Drive Morrisville North Carolina 27560 UNITED STATES OF AMERICA | |
| Charles River Laboratories Germany GmbH Max-Planck-Strasse 15a Erkrath 40699 GERMANY | |
| Charles River Laboratories Inc. 334 South Street Shrewsbury MA 01545 UNITED STATES OF AMERICA | |
| Charles River Laboratories Inc. 466 Devon Park Drive Wayne PA 19087 UNITED STATES OF AMERICA | |
| Charles River Laboratories Ireland Limited Carrentrila Ballina County Mayo IRELAND | |
| Quality Assistance SA Technoparc de Thudinie 2 Donstiennes B-6536 BELGIUM | |
| Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA | |
| Manufacture of Final Dose Form | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 UNITED STATES OF AMERICA |
| Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA | |
| Packing | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 UNITED STATES OF AMERICA |
| Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA | |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, multi-dose, 10 x 5mL Type 1 borosilicate glass with rubber stopper | 100 dose units | 6 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours opened stored at or below 30°C 48 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
COVID-19 Vaccine AstraZeneca is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2 in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 6/7/2023 | Changed Medicine Notification | Contraindications, warnings and precautions - G1; Data sheet - G1 | Granted 21/7/2023 | 11/7/2023 | |
| 21/3/2022 | CMN 24(5) | Indications/dosage - Grade 3; Contraindications, warnings and precautions; Data sheet - miscellaneous changes | Evaluation complete | 28/3/2022 | |
| 10/11/2021 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 11/11/2021 | |
| 29/1/2021 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted 29/7/2021 | 24/2/2021 | Y |
