AusBioMed

Regulatory action due to As there was insufficient evidence to support the indications for the product, the medicine was not safe for the purposes for which it is to be used and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(b), (c) and (j) were incorrect. The goods were also not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the TGAC (see item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations)., effective 27/09/2013