SPORANOX itraconazole 10 mg/mL oral liquid bottle, Janssen-Cilag Pty Ltd , CON-892
Product name
SPORANOX itraconazole 10 mg/mL oral liquid bottle
Sponsor name
Janssen-Cilag Pty Ltd
Consent start
Consent no.
CON-892
Standard
Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of paragraph 8(1)(j) of
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related
medicines (TGO 91), in that the product does not declare the presence of sugar
alcohols on carton and bottle labels in the format required by Schedule 1 of TGO
91.
Therapeutic product type
Prescription medicines