Faecal microbiota, frozen - L - Biomictra , BiomeBank, CON-1033
Product name
Faecal microbiota, frozen - L - Biomictra
Sponsor name
BiomeBank
ARTG
Consent start
Consent no.
CON-1033
Standard
TGO 107 - Standard for Biologicals -Labelling Requirements (TGO 107) clause 10(1)(a) of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
Non-compliance with standard
The products do not conform with clause 10(1)(a) of TGO 107 in that Schedule 2
Part 1 Item 3 states that the product type or name must be on or attached to the
container and primary pack. The trade name BiomeBoost is on the label instead of
the approved trade name Biomictra.
Conditions imposed
1. 'Dear Healthcare Professional' letter identical to that provided to the
Therapeutic Goods Administration will be supplied with each affected batch
explaining the name change.
2. BiomeBank will supply the released batch numbers and date of release to the
Therapeutic Goods Administration (via email) within 30 days of the release.
Therapeutic product type
Blood, tissues, and biologicals