CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial, GMS Australia Pty Limited TA Radpharm Scientific, CON-899
Product name
CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial
Sponsor name
GMS Australia Pty Limited TA Radpharm Scientific
Consent start
Consent no.
CON-899
Standard
Paragraph 8(1)(i), 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 paragraph 8(1)(i),
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 main label and vial label as required by TGO 91, does not
include the name and address of the current sponsor, 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 16 June 2020.
2. The above labels are over-labelled with the current sponsor details.
Therapeutic product type
Prescription medicines