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NEUROLITE bicisate dihydrochloride 0.9 mg/mL kit for the preparation of technetium [99Tc] bicisate injection vial composite pack, Global Medical Solutions Australia Pty Limited, CON-496
Product name
NEUROLITE bicisate dihydrochloride 0.9 mg/mL kit for the preparation of technetium [99Tc] bicisate injection vial composite pack
Sponsor name
Global Medical Solutions Australia Pty Limited
Consent start
Consent no.
CON-496
Duration
The consent is effective from the 16 July 2020 until 31 December 2020.
Standard
Paragraphs 8(3)(b), 9(1)(b) and 10(4)(e) and Section 8(1)(i) and 10(4)(j) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not state the active ingredient names as per the Australian Approved Name and do not reflect the current sponsor name and address.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines