Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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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 |