DEFINITY perflutren lipid microsphere injection vial, GMS Australia Pty Limited TA Radpharm Scientific, CON-898
Product name
DEFINITY perflutren lipid microsphere injection vial
Sponsor name
GMS Australia Pty Limited TA Radpharm Scientific
Consent start
Consent no.
CON-898
Standard
Paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) 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 paragraphs 9(1)(b)-(g),
subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic
Goods Order No. 91 '“ Standard for labels of prescription and related medicines
(TGO 91), in that the product does not state the information on the carton main
label and vial label as required by TGO 91, does not satisfy the formatting of
text on the vial label as required by TGO 91 and does not state the active
ingredient name in accordance with the current Australian Approved Name.
Conditions imposed
1. The affected batches to which this consent applies are printed with the
labels provided under Module 1.3.3.3 mockup-approved in the application
dated 12 June 2020.
2. The above labels are over-labelled with the current sponsor details.
Therapeutic product type
Prescription medicines