ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle, Link Medical Products Pty Ltd T A Link Pharmaceuticals , CON-1169
Product name
ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle
Sponsor name
Link Medical Products Pty Ltd T A Link Pharmaceuticals
Consent start
Consent no.
CON-1169
Standard
Paragraphs 8(1)(a), 9(1)(a),
Paragraphs 8(1)(b) and 9(1)(b), ' Subparagraph 8(1)(j)(iv)(A),
Paragraph 9(3)(a),
Paragraph 8(1)(i),
Paragraph 10(4)(j) and Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Paragraphs 8(1)(b) and 9(1)(b), ' Subparagraph 8(1)(j)(iv)(A),
Paragraph 9(3)(a),
Paragraph 8(1)(i),
Paragraph 10(4)(j) and Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s): will be supplied in the UK approved packaging which has the
following differences: the name Xaluprine in place of Allmercap; the active
ingredient name is referred to as mercaptopurine instead of mercaptopurine
monohydrate; the name and quantity of the active ingredient are not in a
cohesive unit with the name of the medicine; the storage statement is not in the
permitted format; the Schedule 1 substances aspartame and potassium sorbate are
not expressed as required; the sponsor's name and address are not included on
the label and the name of the sponsor is not included on the bottle label.
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 22 September 2023 will be supplied with
each affected batch describing the differences in the labels.
2. Sponsor details will be attached to the labels in such a way as to not
impact any other relevant information on the labels.
Therapeutic product type
Prescription medicines