Revised: 26 August 2026
Medicines
Medsafe Product Detail |
 | |
|---|---|---|
| File ref: TT50-11296 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Panvax H5N8 pre-pandemic | Suspension for injection | 30 mcg/0.5mL | |
| Sponsor | Application date | Regulatory status | Classification |
| Seqirus (NZ) Ltd P O Box 62590 Greenlane Auckland 1546 |
29/04/2024 | Provisional consent Approval date:7/11/2024 Expiry date:7/11/2026 Notification date: 7/11/2024 |
Prescription |
The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Pandemic Plan.
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| suspension for injection | Active | |
| Influenza Virus Type A haemagglutinin 30ug (A/Astrakhan/3212/2020 CBER-RG8A ) | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA | |
| Excipient | ||
| Aluminium as aluminium phosphate adjuvant | ||
| Calcium chloride | ||
| Dibasic sodium phosphate | ||
| Monobasic potassium phosphate | ||
| Monobasic sodium phosphate | ||
| Potassium chloride | ||
| Sodium chloride | ||
| Thiomersal | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Finished Product Testing | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA |
| Finished Product Testing - Microbiological | CSL Behring (Australia) Pty Ltd 189-209 Camp Road, Broadmeadows VIC 3047 AUSTRALIA |
| Manufacture of Active Ingredient | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA |
| Manufacture of Final Dose Form | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA |
| Packing | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA |
| Secondary Packaging | Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 AUSTRALIA |
| NZ Site of Product Release | Seqirus (NZ) Ltd Level 3 60 Parnell Road Parnell AUCKLAND 1052 |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Vial, glass, multi-dose, 10 ml vial, rubber stopper, aluminium seal, plastic cap | 50 vials | 24 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 |
|---|---|---|---|---|---|
| 29/04/2024 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted | 24/05/2024 | Y |
| 6/08/2026 | Provisional Renewal | Renewal of provisional consent | Evaluation complete | 5/10/2026 | |
| 22/09/2026 | Changed Medicine Notification | Finished product testing site | Initial evaluation | 29/09/2026 |
