EVUSHELD tixagevimab 100 mg/mL and cilgavimab 100 mg/mL solution for injection in 150 mg single dose vials, AstraZeneca Pty Ltd, CON-1030

• section 6: the excipients 'L-histidine' and 'L-histidine hydrochloride monohydrate' are not named as per the Australian Approved Names • paragraph 8(1)(d): the dosage form 'solution for injection' is shown as ' injection' and 'each 1.5 mL of solution contains…' • paragraph 8(1)(i): the sponsor address is not included as they are international artworks. Details can be found by scanning the QR code or going to 'laab.azcovid-19.com' • subsection 8(2): the international cartons don't include a dispensing label • paragraph 9(1)(d): 'injection' is included on the main panel and 'solution' is included on the back panel as part of 'each 1.5mL of solution contains…' • paragraphs 9(3)(a) and (b): the name of the medicine, active ingredient and quantity are not presented in the required cohesive layout • subsection 9(5): the name of the active ingredients and quantity have a text height of less than 3.0 millimetres • paragraph 10(4)(f): the dosage form is described as 'injection' on the vial labels.