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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
Duration
The consent is effective for all relevant batches released from 20 December 2021 until 30 June 2022.
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
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.The above labels are over-labelled with the current sponsor details.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines