TRUXIMA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion, Celltrion Healthcare Australia Pty Ltd, CON-1150

The product's vial label does not comply as follows: 'subsection 7(1) - The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine. The vial label is not compliant with this subsection as detailed below. 'paragraph 9(1)(d) - the name of the dosage form is not included on the on the label, only '..for Injection' and I.V. infusion included. 'paragraph 8(1)(i) - the vial label does not include distributor details of the medicine. 'paragraph 10(3)(a) - the vial label does not include the excipient details of the medicine. ' paragraph 10(3)(b) - the vial label does not include the statements 'Úse in one patient on one occasion. Contains no antimicrobial preservative' only includes text 'Discard unused portion.' ' paragraph 10(3)(c) the vial label only includes wording 'Dilute before use' rather than the statement 'Do not to administer the solution undiluted.'