ANTIZOL fomepizole 1.5 g/1.5 mL concentrated injection vial, AFT Pharmaceuticals, CON-525
Product name
ANTIZOL fomepizole 1.5 g/1.5 mL concentrated injection vial
Sponsor name
AFT Pharmaceuticals
Consent start
Consent no.
CON-525
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of paragraphs 8(1)(k), 7(2)(d),
8(1)(c), 8(1)(h), subsections 2(f), 2(d), and paragraphs 8(1)(i) and 9(1)(g) of
the Therapeutic Goods Order No. 91. Specifically the product carton labels lack
appropriate warning statements;storage conditions are not set out as approved;a
quantity of mg/mL is included;the route of administration is not on the main
label;the presence of a preservative is not stated;the dosage form name is
incomplete [should be concentrated injection];the excipients present and their
quantity is not stated;the statement of quantity of the active is not as
approvedfor the vial labels a quantity of mg/mL is included;the dosage form name
is incomplete [should be concentrated injection]; andthe Australian sponsor's
name or trademark is missing.
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration in the correspondence dated 31 July 2020 will
be supplied with each affected batch, setting out the circumstances of the
section 14 consent and other matters relating to safe use of the product;
The labels to which this consent applies are those supplied with the
correspondence dated 31 July 2020, and the carton labels will be overstickered
with the number, Australian sponsor address details, the batch number and
the correct Australian expiry date as agreed in your correspondence.
Therapeutic product type
Prescription medicines