FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection, Sanofi Aventis Australia Pty Ltd, CON-333

European Pharmacopeia (01/20190158) - Passage level of five of the working seed lots is beyond the limit indicated in the standard (0158). The test for BacterialEndotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusiontest (2.7.1) are not performed on the Final Lot. Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)' The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on thefollowing paragraph8(1)(d) the name of the dosage form (missing on carton) paragraph8(1)(i) the name and contact details of the sponsor (missing on carton) subparagraph8(1)(j)(iv)(A) indicating that the medicine contains the substanceexpressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton) paragraph9(1)(b) the name(s) of all active ingredients in the medicine (missingon syringe) paragraph9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe) subsection9(3) the name of the medicine and the name of active ingredients onthe main label (they are placed separately as the same texts in Spanish are placedbefore English texts) paragraph10(5)(c) the name of the medicine is displayed in a text size of not lessthan 1.5 millimetres (the trade name 'FluQuadri' is less than 1.5 mm on syringe) paragraph11(1)(a) use of appropriate metric units (the abbreviation 'mcg' isused rather than 'microgram' in full on carton) subsection11(5) permitted statements of storage temperature conditions ('Store between +2ÌŠ C to +8ÌŠ C. Do not freeze' is used rather than 'Store at 2ÌŠ C to 8ÌŠ C'(Refrigerate. Do not freeze) on carton).