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FYZANT Icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe, Juno Pharmaceuticals Pty Ltd, CON-1186
Product name
FYZANT Icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe
Sponsor name
Juno Pharmaceuticals Pty Ltd
Batches
35000294
Consent start
Consent no.
CON-1186
Duration
The consent is effective from 4 December 2023 until 31 March 2024.
Standard
Paragraph 7(2)(e), Paragraph 9(1)(e), Paragraph 10(5)(d), Subparagraph 11(2)(f)(v). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product has the strength and AUST R number in white text on an orange
background which may provide poor colour contrast and the label includes the
solution strength of 10 mg/mL alongside the actual quantity of 30 mg/3 mL
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines