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BiomeBoost Faecal Microbiota Transplant, BiomeBank, CON-866
Product name
BiomeBoost Faecal Microbiota Transplant
Sponsor name
BiomeBank
Batches
Batches BB165/167
Consent start
Consent no.
CON-866
Duration
The consent is effective from 14 September 2021 until 31 October 2021.
Standard
Subparagraphs 13(3)(a)(ii) and (iii), 13(3)(b)(ii) and (iii), paragraphs 13(4)(b) and (c) of Therapeutic Goods Order No. 105 - Standard for Faecal Microbiota Transplant Products
Non-compliance with standard
The product does not conform to the requirements of subparagraphs 13(3)(a)(ii)
and (iii), 13(3)(b)(ii) and (iii), paragraphs 13(4)(b) and (c) of Therapeutic
Goods Order No. 105 - Standard for Faecal Microbiota Transplant Products, in
that blood and stool testing will not be collected as described for FMT products
other than fresh FMT products.
Conditions imposed
It is a condition of approval that the product be administered only for the
treatment of Clostridium difficile infection in the single patient specified in
the application form, after obtaining informed consent.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals