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Cancellations and suspensions

This database records details of medicines and medical devices that have been cancelled or suspended, and no longer appear in the ARTG.

Following a review by the TGA, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 30 of the Therapeutic Goods Act 1989.

Where other actions are taken in relation to safety, a link to the TGA's safety alert will be included in the database under 'Further information'.

The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.

The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.

To find out whether a product is currently authorised for supply in Australia, check the ARTG.

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Find out more about Cancellations and Suspensions.

1921 result(s) found, displaying 1651 to 1675

  • Heat exchanger, heart-lung bypass (Cancelled from ARTG under subsection 41GN(1)(b) of the Act)

    Cancellation or suspension
    Regulatory action due to As the sponsor did not provide information under section 41JA of the Act, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(c) of the Act. As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(2) of the Act. As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(a) of the Act. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices. Other devices under the entry remain., effective 25/07/2017

  • Heating unit, pad, water, system (Cancelled from ARTG under S41GN(1)(b))

    Cancellation or suspension
    Regulatory action due to As the sponsor did not provide information under 41JA, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN (3)(C). As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(2). As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(3)(a). However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Flextherm and Stockert Heater-Cooler 1T., effective 04/07/2017

  • HomeCare Hi Lo Hospital Bed (Cancelled from the ARTG under s.41GN(1)(b))

    Cancellation or suspension
    Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 26/05/2017

  • Omega Baby Vital Plus (Cancelled from the ARTG under 30(1C) of the Act)

    Cancellation or suspension
    Regulatory action due to The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods., effective 21/03/2017

  • Pillow (Cancelled from the ARTG under s.41GN(1)(b))

    Cancellation or suspension
    Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 03/03/2017

  • Positioning aid system (Cancelled from the ARTG under s.41GN(1)(b))

    Cancellation or suspension
    Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 03/03/2017

  • Home CPAP Unit (Cancelled from the ARTG under s.41GN(1)(b)(c) and (f))

    Cancellation or suspension
    Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 11/01/2017
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