RAPIVAB peramivir 200 mg / 20 mL concentrate for intravenous infusion glass vial, Biocelect Pty Ltd, CON-870

The product does not conform with the requirements of Section 6 ‘main label’; Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(h), 9(1)(g) and 9(3)(a); and Subparagraphs 10(3)(a)(i) of TGO 91 in that the product packaging does not comply with the following • The carton label does not include the medicine name more conspicuously on the main panel; does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; does not include the statement ‘Protect from light’; does not include the words ‘for infusion’ adjacent to the name of the dosage form; does not include the name and quantity of the active ingredient together on one line immediately below the medicine name; and does not state the amount of the excipient ‘sodium chloride’ in the volume of fill of the injection in the container (i.e. 20 mL). • The vial label does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; and does not include the statement ‘Protect from light’.