EVUSHELD tixagevimab 100 mg/ mL and cilgavimab 100 mg/ mL solution for injection in 150 mg single dose vials, AstraZeneca Pty Ltd, CON-952

The product label does not comply with the TGO 91 regarding the following information A blanket exemption for TGO91 compliance is approved for the international artworks presented. The main non-compliances with TGO91 are • the excipients 'L-histidine' and 'L-histidine hydrochloride monohydrate' are not named as per the Australian Approved Names. • the dosage form 'solution for injection' is shown as ' injection' and 'each 1.5 mL of solution contains…' • 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'. • the international cartons do not include a dispensing label. • 'injection' is included on the main panel and 'solution' is included on the back panel as part of 'each 1.5mL of solution contains…' • the name of the medicine, active ingredient and quantity are not presented in the required cohesive layout. • the name of the active ingredients and quantity have a text height of less than 3.0 millimetres. • the dosage form is described as 'injection' on the vial labels.