Vaxchora Vibrio cholerae bacteria cells (CVD 103-HgR strain) 4 x 10^8 to 2 x 10^9 CFU suspension, powder for, sachet, Biocelect Pty Ltd, CON-1187

1. This consent applies only to VAXCHORA(AUST R 389746); Batch: 4309489 (Expiry: 31 December 2024). Quantity: 2000 doses– As indicated in your email dated 01 December 2023 2. Non-compliance withTherapeutic Goods Order No 9191 – Standard for labels of prescription and related medicinesis limited to the information detailed in the submission. 3. Carton and sachet labels for Batch: 4309489, as well as the over-stickered carton as provided with the letter of 02 November 2023 4. A‘Dear Healthcare Professional’(HCP) letter, identical to that provided to the Therapeutic Goods Administration (TGA) in the email on the 22 November 2023, will be appropriately provided as described in that communication. This letter will explain why the product is supplied in UK packaging and instruct the HCP to convey this information to the patient and to provide the patient with the Patient Information Leaflet (PIL) identical to that provided to the TGA in the above cited email and a copy of the Australian approved Consumer Medicine Information (CMI).