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ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle , Link Medical Products Pty Ltd T A Link Pharmaceuticals, CON-1388
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-1388
Duration
The consent is effective from 14 July 2025 until 1 June 2026.
Standard
Paragraphs 8(1)(a) and 9(1)(a); 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 products do not comply because they are supplied in the UK approved
packaging which has the following differences: 1. the name Xaluprine in place of
Allmercap; 2. the name and quantity of the active ingredient are not in a
cohesive unit with the name of the medicine; 3. the storage statement is not in
the permitted format; 4. the Schedule 1 substances are not expressed as
required; 5. 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 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.
3. Signal headings and the registration number will be attached as described in
the previous Section 14 consent.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines