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CISPLATIN ACCORD cisplatin 25 mg/25 mL concentrated injection vial , Accord Healthcare Pty Ltd, CON-279

Product name
CISPLATIN ACCORD cisplatin 25 mg/25 mL concentrated injection vial
Sponsor name
Accord Healthcare Pty Ltd
Consent start
Consent no.
CON-279
Duration
The consent is effective from 5 July 2018 until further notice.
Standard
Paragraphs 8(1)(i) and 8(1)(n) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
​The product labels do not have sufficient space to include the name and contact details of the sponsor and the machine readable code on the vial label.
Conditions imposed
    ​1. the vials will be supllied in a carton that complies with all of the requirements of the Therapeutic Goods Order No.91.     2. The approved labels are those approved during review of the registration application.  
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines

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