CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial, Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, CON-695
Product name
CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial
Sponsor name
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Consent start
Consent no.
CON-695
Standard
Paragraphs 8(1)(i), 9(1)(b)-(g), 9(3), 9(5), 11(1)(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 product(s) do not conform to the requirements of Therapeutic Goods Order No.
91, in that the products do not state the main label and vial label information
as required by TGO 91, do not include the name and address of the current
sponsor; and do not state the active ingredient names as per the Australian
Approved Name.
Therapeutic product type
Prescription medicines