FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled PRTC syringe without needle, GlaxoSmithKline Australia Pty Ltd, CON-275

Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)- The batch is packaged in the General Export Pack, which does not conform with the requirements of the TGO 91 on the following#58; Paragraph 8(1)(b) '“ the name(s) of all active ingredients in the medicine '“ the name of the active ingredient (influenza virus haemagglutinin) is not explicitly stated '“ either on the carton Paragraphs 8(1)(f) and (g) the formatting of the batch number prefix and the expiry date prefix does not comply. Paragraph 8(1)(i) The name and contact details of the Australian sponsor are not provided. Paragraph 8(1)(j)(A) - the statement indicating the product is manufactured in eggs is missing. Paragraph 8(1)(k) statements of 'Medicinal product subject to medical prescription' and 'Keep out of the sight and reach of children' are misplaced and does not include the text 'For use in 3 years and above only' and text 'Do not accept if seal is broken' Paragraph 8(1)(n) a machine-readable code is not present. Paragraph 8(1)(o) The name of the medicine is not included on three non-opposing sides of the carton. Paragraph 9(3)(a)(i) the placement of the medicine name and the active ingredient does not comply. Subsection 9(5) the quantity of the active ingredients is not displayed in a text size of not less than 3.0 millimetres. Paragraph 10(5)(e)(f) The container label has incorrect placement of the prefixes for the batch number and expiry dates. Paragraph 10(5)(h) the content of the active ingredient is not included i.e. quot;60 mg HAquot; being the acceptable abbreviation. Subsection 11(5) The permitted statement quot;Store at 2ËšC to 8ËšC (Refrigerate. Do not freeze)quot; is not applied correctly (the carton states Storage#58; 2ËšC - 8ËšC).