ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle, Link Medical Products Pty Ltd T A Link Pharmaceuticals, CON-1157

Paragraphs 8(1)(a) and 9(1)(a) that the label and the main label must include the name of the medicine; ' Paragraphs 8(1)(b) and 9(1)(b) - the name(s) of all active ingredients in the medicine (where name refers to the AAN of the ingredient) ' Subparagraph 8(1)(j)(iv)(A) - where: (i) a substance or substance within the group of substances referred to in Column 1 of Schedule 1 to this Order is present in the medicine; and (ii) the circumstances as set out in Column 2 of Schedule 1 exist in relation to such a substance or no circumstances are set out in Column 2; and (iii) the medicine is intended to be administered via any one or more of the route(s) of administration referred to in Column 3 of Schedule 1, then: (iv) a statement: (A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; Paragraph 9(3)(a) The name of the medicine and the name(s) of active ingredient(s) on the main label must appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text.. Paragraph 8(1)(i) -the name and contact details of the sponsor or distributor of the medicine; Paragraph 10(4)(j) - the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine is required on the bottle; and Subsection 11(5) '“ Permitted statements of storage temperature conditions. , in that 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 mecaptopurine 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.