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ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle, Link Medical Products Pty Ltd T A Link Pharmaceuticals, CON-1283
Product name
ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle
Sponsor name
Link Medical Products Pty Ltd T A Link Pharmaceuticals
Consent start
Consent no.
CON-1283
Duration
The consent is effective from 21 October 2024 until 31 August 2025.
Standard
Paragraphs 8(1)(a) and 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); Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products 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 are not expressed as required; the sponsors name and address are not included on the label and the name of the sponsor is not included on the bottle label.
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch describing the differences in the labels. Sponsor details will be attached to the labels in such a way as to not impact any other relevant information on the labels. Signal headings and the registration number will be attached.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines