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