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ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle, Link Medical Products Pty Ltd T A Link Pharmaceuticals, CON-1236
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-1236
Duration
The consent is effective from 10 May 2024 until 28 February 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 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 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
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 26 April 2024 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.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines