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Aurora Pharmaceuticals Pty Ltd

Regulatory activities for this sponsor.

Type

Date

2 result(s) found, displaying 1 to 2

  • Vitamax Calcium 600mg + Vitamin D (Cancelled under s30(1A)(a) s30(2)(b), (ba) and (c))

    Cancellation or suspension
    Regulatory action due to The goods: are 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); have changed so that they have become separate and distinct from the goods in the ARTG. The sponsor has failed to comply with a condition of listing under s28(5)(ab) (that the goods would not advertise the goods for an indication other than those accepted in the Register). The certification under s26A(2)(c) (that the presentation of the goods is not unacceptable) is incorrect., effective 14/06/2013

  • Vitamax Calcium 600mg (Cancelled under s30(1A)(a) and s30(2)(c))

    Cancellation or suspension
    Regulatory action due to The goods are 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). The sponsor has failed to comply with a condition of listing under s28(5)(ab) (that the goods would not advertise the goods for an indication other than those accepted in the Register)., effective 14/06/2013