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ULTRAVIST 370 iopromide 153.77 g/200 mL injection bottle, Bayer Australia Ltd, CON-1018
Product name
ULTRAVIST 370 iopromide 153.77 g/200 mL injection bottle
Sponsor name
Bayer Australia Ltd
Consent start
Consent no.
CON-1018
Duration
The consent is effective for all batches of the products released for supply from 20 October 2022 until 20 October 2024.
Standard
Paragraph 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not include the statement ‘Use in one patient on one occasion
only’, rather the label states ‘For use in a single-use setting or with an
automated contrast injection system approved for multi-patient use’.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines