Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-4578 |
| Trade Name | Dose Form | Strength | Identifier |
| Plaquenil | Film coated tablet | 200 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 31/12/1969 | Consent given Approval date: 31/12/1969 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Hydroxychloroquine sulfate 200mg | Chinoin Pharmaceutical & Chemical Works Co Ltd To utca 1-5 Budapest H-1045 Hungary | |
| Excipient | ||
| Calcium hydrogen phosphate dihydrate | ||
| Carnauba wax | ||
| Ready to Use White Colorant (corresponding generic name to Opadry® YS-1-7443) | ||
| Macrogol 400 | ||
| Magnesium stearate | ||
| Maize starch |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Sanofi Winthrop Industrie 1 Rue de la Vierge Ambares Et Lagrave Carbon Blanc Cedex 33565 France |
| Packing | Contract Pharmaceutical Services of Australia Pty Ltd 5 Eden Park Drive North Ryde NSW 2113 Australia |
| DHL Exel Supply Chain (Australia) Pty Ltd 16 Picrite Close Greystanes NSW 2145 Australia | |
| DHL Exel Supply Chain (Australia) Pty Ltd 227 Walters Road Arndell Park NSW 2148 Australia | |
| DHL Exel Supply Chain (Australia) Pty Ltd 52 Huntingwood Drive Huntingwood New South Wales 2148 Australia | |
| Sanofi Winthrop Industrie 30-36 Avenue Gustave Eiffel Tours 37100 France | |
| Secondary Packaging | Access Industries for the Disabled Ltd t/a Access Industries 131 Station Rd Seven Hills NSW 2147 Australia |
| Linfox Australia 27-49 Lenore Drive Erskine Park New South Wales 2759 Australia | |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| 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 |
| Bottle, glass, 1x100 | 100 tablets | 60 months from date of manufacture stored at or below 30°C |
| Bottle, plastic, 100 mL HDPE/ child res. seal 1x100 | 100 tablets | 36 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, 60 mL HDPE/ child res. seal 1x100 | 100 tablets | 36 months from date of manufacture stored at or below 25°C |
Indications
Acute and chronic rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 18/12/2022 | Changed Medicine Notification | Formulation - G1; Finished product manufacture - G1 | Granted 13/3/2023 | 21/12/2022 |
