COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial, AstraZeneca Pty Ltd, CON-770

The product does not conform with the requirements of section 6 (interpretation - name of an activeingredient), paragraphs 8(1)(b), 8(1)(c), 9(3)(a), subparagraph 10(3)(a)(iii), paragraph 10(4)(b), subparagraphs 11(2)(f)(iv), 11(2)(k)(ii) and 11(3)(b)(iii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that The name of the active ingredient (ChAdOx1-S [recombinant]) has not been accepted for inclusion on the Australian Approved Names List.The quantity or proportion of active ingredient in the medicine is not shown on the labels.The quantity of the active ingredient is not shown on the label.Quantity of the excipients per dose volume (i.e. per 0.5 mL) not shown on the carton.Primary pack label does not comply with section 8, 9 and subsection 10(3).Expression of quantity or proportion of active ingredients not shown on the labels.A number of biological organisms (i.e. 'vp '“ viral particles') present per metric unit, are not shown on the label.The potency units (i.e. 'vp '“ viral particles') are not expressed on the labels.