XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial, GlaxoSmithKline Australia Pty Ltd, CON-920

The following elements of the packaging do not comply with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) VIALTGO 91, subsections 10(4) - the vial label does not include the name of the the dosage form as approved in Australia. CARTONTGO 91, section 8(1)(d),(h),(i),(k) - the name of dosage is not in accordance with the TGA approved name, the storage conditions Store in a refrigerator is not in accordance with the TGA approved storage condition of 2°C to 8°C, the name and details of the Australian Sponsor are not included although the GSK logo is included and relevant signal headings and warning statements are not included. TGO 91, section 8(2) - no space is available for the dispensing label. TGO 91, section 9(1)(d),(e),(g)- the name of the dosage form is not in accordance with the TGA approved name, the quantitiy of medicine is not included on main panel, the statement IV for infusion are not placed adjacent to one another. TGO 91, section 9(3) - The name of the medicine and the active ingredient do not appear together as a cohesive unit on the main panel. TGO 91, section 10(3)(a) - each excipient in the medicine is stated, however, the quantity of each ingredient is not included and names are not in accordance with AAN. TGO 91, section 10(3)(b) - a statement Use in one patient on one occasion only. Contains no antimicrobial preservative or words to that effect is not included.