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LIORESAL 25 baclofen 25 mg tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-755

Product name
LIORESAL 25 baclofen 25 mg tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Batches
BVJ74
Consent start
Consent no.
CON-755
Standard
Paragraph 8(1)(j); and subsections 8(2), 9(3) and 9(5) 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 with the requirements of paragraph 8(1)(j); and subsections 8(2), 9(3) and 9(5) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines in that the carton label for the product mentioned above do not declare Schedule 1 substances (Gluten as wheat starch), do not indicate a dedicated space for a dispensing label, do not include the name and quantity of the active ingredient immediately underneath the medicine name and do not include the name of the active ingredient on the main panel in the text size of at least 3.0 mm.
Therapeutic product type
Prescription medicines

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