Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-11205 |
| Trade Name | Dose Form | Strength | Identifier |
| NUVAXOVID XBB.1.5. | Suspension for injection | 10 mcg/mL | (COVID-19 Vaccine with Matrix-M Adjuvant) |
| Sponsor | Application date | Registration situation | Classification |
| Biocelect New Zealand Ltd Level 5, Wynn Williams House 47 Hereford Street Christchurch 8013 | 30/10/2023 | Pending | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| suspension for injection | Active | |
| SARS-CoV-2 rs 10 µg/mL (Omicron XBB.1.5) | Serum Institute of India Pvt Ltd S. No. 105-110, Manjari BK Pune-412 307 Maharashtra INDIA | |
| Excipient | ||
| Cholesterol | ||
| Dibasic sodium phosphate heptahydrate | ||
| Hydrochloric acid | ||
| Monobasic potassium phosphate | ||
| Monobasic sodium phosphate monohydrate | ||
| Phosphatidylcholines, egg | ||
| Polysorbate 80 | ||
| Potassium chloride | ||
| Quillaja saponaria | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Novavax AB Kungsgatan 109 Uppsala SE- 753 18 SWEDEN |
| Serum Institute of India Pvt Ltd S. No. 105-110, Manjari BK Pune-412 307 Maharashtra INDIA | |
| Manufacture of Final Dose Form | Serum Institute of India Pvt Ltd S. No. 105-110, Manjari BK Pune-412 307 Maharashtra INDIA |
| Packing | Serum Institute of India Pvt Ltd S. No. 105-110, Manjari BK Pune-412 307 Maharashtra INDIA |
| Secondary Packaging | DHL Supply Chain (Australia) Pty Limited 25 Ottelia Road Kemps Creek NSW 2178 AUSTRALIA |
| Serum Institute of India Pvt Ltd S. No. 105-110, Manjari BK Pune-412 307 Maharashtra INDIA | |
| 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, 5 x 0.5 mL doses per vial, 2 vials per pack | 10 dose units | 9 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
| Vial, glass, multi-dose, 5 x 0.5 mL doses per vial, 10 vials per pack | 50 dose units | 9 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 30/10/2023 | Provisional Consent (Section 23) | Provisional consent (clinical need) higher-risk NCE | Information requested 6/5/2024 | 22/11/2023 | Y |
