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
Product name
Vaxchora Vibrio cholerae bacteria cells (CVD 103-HgR strain) 4 x 10^8 to 2 x 10^9 CFU suspension, powder for, sachet
Sponsor name
Biocelect Pty Ltd
Batches
4309489
Consent start
Consent no.
CON-1187
Standard
clauses/sections/subsections of the standard: 8(1)(b), 8(1)(c), 8(1)(d), 8(1)(j), 8(1)(l), 9(1)(b), 9(1)(c), 9(1)(d), 9(3), 10(13)(a)(v, vi and vii). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product is supplied in UK packaging
Conditions imposed
1. This consent applies only to VAXCHORA (389746); Batch: 4309489
(Expiry: 31 December 2024).
Quantity: 2000 doses '“ As indicated in your email dated 01 December 2023
2. Non-compliance with Therapeutic Goods Order No 9191 '“ Standard for labels
of prescription and related medicines is 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).
Therapeutic product type
Prescription medicines