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HERZUMA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial, Celltrion Healthcare Australia Pty Ltd, CON-1149
Product name
HERZUMA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial
Sponsor name
Celltrion Healthcare Australia Pty Ltd
Batches
0A5C02
Consent start
Consent no.
CON-1149
Standard
subsection 7(1), paragraph7(2)(b), paragraph 10(3)(b), paragraph 10(4)(f), paragraph 10(4)(j), paragraph 11(5)(iii). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product's vial label does not comply as follows due to international
labelling: ' 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. ' subsection 7(2)(b) - Information on the vial label is
presented in both French and English. ' subsection 10(3)(b) - The vial does not
state "Contains no antimicrobial preservative. Use in one patient on one
occasion only." ' subsection 10(4)(f) '“ The vial label states "Trastuzumab for
Injection". The AU vial label states "Powder for injection" subsection 10(4)(j)
- The vial label does not include the Australian Sponsor details. ' subsection
11(5)(iii) - The label states "Store at 2°C to 8°C", but does not contain
"(Refrigerate. Do not freeze)".
Conditions imposed
1. A 'HCP' letter identical to that provided to the Therapeutic Goods
Administration on 3 August 2023 will be supplied with each affected batch.
2. The labels to which this consent applies are for the batch of the product
stated in the letter.
Therapeutic product type
Prescription medicines