DRAXIMAGE MACROSALB kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection vial, Jubilant Pharma Australia Pty Ltd, CON-666

Paragraph 8(1)(n) (o) '“ There is no machine readable code on the carton; and the name of the medicine is on three sides but they are not non-opposing. Paragraph 9(1)(b)(c) (e) '“ The name and quantity of the active ingredient on the main label is not indicated (Albumin Aggregated 2.5 mg), and the quantity of medicine (10 reaction vials) on the main label is not indicated. Subparagraph 9(3)(a)(i) '“ The name of the active ingredient is not mentioned immediately below the name of the medicine. Subsection 9(5) '“ The name and the quantity of the active ingredient (Albumin Aggregated 2.5 mg) should be added in a text size of not less than 3.0 millimetres. Paragraph 10(4)(d) (k) '“ The name and the quantity of the active ingredient (Albumin Aggregated 2.5 mg) is already on the vial label with a text size of 1.7 mm but you considered it non-compliant on the basis of additional information provided in your request; and the route of administration is not included on the vial label.