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 T/A Radpharm Scientific, CON-697
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 T/A Radpharm Scientific
Consent start
Consent no.
CON-697
Standard
Paragraphs 8(1)(i), 8(3)(b), 9(1)(b)-(g), subsections 9(3), 9(5), paragraphs 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 products do not state the main label and vial label information as required
by TGO 91, do not state the active ingredient names as per the Australian
Approved Name and do not reflect the current sponsor name and address.
Therapeutic product type
Prescription medicines