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
Duration
The consent is effective from 2 February 2021 until 30 June 2021 or until the batch is depleted.
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.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines