Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-10862 |
| Trade Name | Dose Form | Strength | Identifier |
| COVID-19 Vaccine Janssen | Suspension for injection | 5x10^10 VP/0.5mL | |
| Sponsor | Application date | Registration situation | Classification |
| Janssen-Cilag (New Zealand) Ltd P O Box 62185 Sylvia Park Auckland 1644 | 8/12/2020 | Approval lapsed Approval date: 7/7/2021 Notification date: 7/11/2023 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| suspension for injection | Active | |
| Ad26.COV2.S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 8.92 log10 infectious units per dose) | Janssen Biologics BV Einsteinweg 101 Leiden 2333 CB NETHERLANDS | |
| Excipient | ||
| Citric acid monohydrate | ||
| Ethanol | ||
| Hydrochloric acid | ||
| Hydroxypropyl-beta-cyclodextrin | ||
| Polysorbate 80 | ||
| Sodium chloride | ||
| Sodium citrate dihydrate | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Eurofins Biolab Srl Via Bruno Buozzi, 2 Vimodrone Milan 20055 ITALY |
| Eurofins BioPharma Product Testing Columbia Inc 4780 Discovery Drive Columbia Missouri 65201-8949 UNITED STATES OF AMERICA | |
| Eurofins Proxy Laboratories BV Archimedesweg 25 Leiden 2333 CM NETHERLANDS | |
| Grand River Aseptic Manufacturing Inc 6670 Patterson Ave Se Suite 1a Caledonia Michigan (MI) 49316 UNITED STATES OF AMERICA | |
| Janssen Biologics BV Einsteinweg 101 Leiden 2333 CB NETHERLANDS | |
| Janssen Vaccines & Prevention BV Archimedesweg 4-6 Leiden 2333 CN NETHERLANDS | |
| Finished Product Testing - Microbiological | Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha 6020 SOUTH AFRICA |
| BioReliance Limited West of Scotland Science Park Todd Campus Glasgow G20 0XA UNITED KINGDOM | |
| Catalent Anagni SRL Localita Fontana del Ceraso SP Casilina Anagni 41 03012 ITALY | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 UNITED STATES OF AMERICA | |
| Grand River Aseptic Manufacturing Inc 140 Front Avenue SW Grand Rapids Michigan 49504 UNITED STATES OF AMERICA | |
| Sanofi Pasteur 1541 Avenue Marcel Merieux Marcy L'Etoile 69280 FRANCE | |
| SGS Life Science Services 616 Heathrow Drive Lincolnshire IL 60069 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha 6020 SOUTH AFRICA |
| Catalent Anagni SRL Localita Fontana del Ceraso SP Casilina Anagni 41 03012 ITALY | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 UNITED STATES OF AMERICA | |
| Grand River Aseptic Manufacturing Inc 140 Front Avenue SW Grand Rapids Michigan 49504 UNITED STATES OF AMERICA | |
| Sanofi Pasteur 1541 Avenue Marcel Merieux Marcy L'Etoile 69280 FRANCE | |
| Packing | Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha 6020 SOUTH AFRICA |
| Catalent Anagni SRL Localita Fontana del Ceraso SP Casilina Anagni 41 03012 ITALY | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 UNITED STATES OF AMERICA | |
| Grand River Aseptic Manufacturing Inc 140 Front Avenue SW Grand Rapids Michigan 49504 UNITED STATES OF AMERICA | |
| Sanofi Pasteur 1541 Avenue Marcel Merieux Marcy L'Etoile 69280 FRANCE | |
| Secondary Packaging | Aspen SA Sterile Operations (Pty) Ltd 8B Gibaud Road Korsten Gqeberha 6020 SOUTH AFRICA |
| Catalent Anagni SRL Localita Fontana del Ceraso SP Casilina Anagni 41 03012 ITALY | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 UNITED STATES OF AMERICA | |
| Grand River Aseptic Manufacturing Inc 6670 Patterson Ave Se Suite 1a Caledonia Michigan (MI) 49316 UNITED STATES OF AMERICA | |
| Janssen Pharmaceutica NV Turnhoutseweg 30 Beerse B-2340 BELGIUM | |
| Packaging Coordinators LLC 3001 Red Lion Road Philadelphia Pennsylvania 19114 UNITED STATES OF AMERICA | |
| Sharp Corporation 7451 Keebler Way Allentown Pennsylvania 18106 UNITED STATES OF AMERICA | |
| NZ Site of Product Release | Janssen-Cilag (New Zealand) Ltd 507 Mt Wellington Highway AUCKLAND 1060 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, multi-dose, 10 x 2.5mL 2R Type 1 glass vial closed with latex-free chlorobutyl rubber stopper | 50 dose units | 24 months from date of manufacture stored below -20°C (Deep freeze) protect from light 11 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours opened stored at or below 25°C protect from light |
Indications
COVID-19 Vaccine Janssen has provisional consent for the indication below:
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 |
| 21/9/2022 | Changed Medicine Notification | Active ingredient method of manufacture - Grade 2; Finished product testing site; Finished product manufacturing process - Grade 3 | Granted 3/11/2022 | 28/9/2022 | |
| 8/12/2020 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted 7/7/2021 | 22/12/2020 | Y |
