DEFINITY perflutren lipid microsphere injection vial, Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, CON-713
Product name
DEFINITY perflutren lipid microsphere injection vial
Sponsor name
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Consent start
Consent no.
CON-713
Standard
Paragraphs 8(3)(b), 9(1)(b)-(g), subsections 9(3), 9(5), paragraphs 10(4)(c)-(d) and 10(4)(d)-(k) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform to the requirements of paragraphs 8(3)(b),
9(1)(b)-(g), subsections 9(3), 9(5), paragraphs 10(4)(c)-(d) and 10(4)(d)-(k) of
the Therapeutic Goods Order No. 91 - Standard for labels of prescription and
related medicines, in that the products do not state the information on the main
label and vial label as required by TGO 91 and, do not state the active
ingredient names as per the Australian Approved Names.
Therapeutic product type
Prescription medicines