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
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 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
Therapeutic product type
Prescription medicines