MALTOFER Tablets, Vifor Pharma Pty Ltd, CON-1119
Product name
MALTOFER Tablets
Sponsor name
Vifor Pharma Pty Ltd
Consent start
Consent no.
CON-1119
Standard
paragraphs 10 (8)(a)(v), 10 (8)(a)(vi) and 10 (8)(a)(vii) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
The name on the proposed blister label is 'Maltofer', instead of Therapeutic
Goods Administration (TGA) approved product name 'Maltofer Tablets'. ' The name
of the active ingredient on the proposed blister label is 'iron as iron
(III)-hydroxide polymaltose complex (IPC)', instead of 'iron as iron
polymaltose' on the TGA approved blister label. ' The quantity of iron on the
proposed blister label is depicted as 100 mg, instead of 100 mg iron as 370 mg
iron polymaltose presented on the TGA approved blister label.
Therapeutic product type
Over-the-counter medicines