Australian approved name (AAN): Bacillus coagulans
Common names and synonyms: Probiotic
Warnings and Restrictions: Only to be used in a medicine where Pathway International Pty Ltd (Client ID 23355), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 2 September 2021.
Only permitted for use in medicines:
– limited to oral routes of administration; and
– when the strain of Bacillus coagulans is confirmed to be Microbial Type Culture Collection (MTCC) accession number 5260.
The strain of Bacillus coagulans must be declared on the label. The maximum recommended daily dose of the medicine must not provide more than 6 billion CFU of Bacillus coagulans.
The following warning statements are required on the medicine label:
CHILD2 – Not suitable for children.
BACCOAG – Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).
Allowable purpose of the ingredient: Active