Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-4578
Trade NameDose FormStrengthIdentifier
PlaquenilFilm coated tablet200 mg
SponsorApplication dateRegistration situationClassification
sanofi-aventis new zealand limited
P O Box 12851
Penrose
AUCKLAND 1642
31/12/1969Consent given
Approval date: 31/12/1969
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Hydroxychloroquine sulfate 200 mgChinoin Pharmaceutical & Chemical Works Co Ltd
To utca 1-5
Budapest H-1045
Hungary
 Excipient 
 Calcium hydrogen phosphate dihydrate
 Macrogol 400
 Maize starch
 Opadry white YS-1-7443
 Purified water
 Tekprint black SB-9014SD

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormSanofi Winthrop Industrie
1 Rue de la Vierge
Ambares Et Lagrave
Carbon Blanc Cedex 33565
France
PackingContract 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 PackagingAccess 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 ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Bottle, glass, 1x100100 tablets60 months from date of manufacture stored at or below 30°C
Bottle, plastic, HDPE/ child res. seal 1x100100 tablets36 months from date of manufacture stored at or below 25°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
16/10/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified22/10/2020 
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