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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Action
- Medicine suspension (87)
- Medical device cancellation (84)
- Medicine cancellation (58)
- Complementary medicine cancellation (47)
- Revocation of a TGA issued Conformity Assessment Certificate (19)
- Medical device suspension (14)
- Revocation of a TGA issued Conformity Assessment Certificate. (3)
- Medical device cancellation - certain devices within an entry (1)
- Medical device cancellation - requested by the sponsor - certain devices within an entry (1)
- Voluntary revocation at the request of the manufacturer. (1)
Find out more about Cancellations and Suspensions.
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316 result(s) found, displaying 251 to 275
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory 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 17/10/2016
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Cancellation or suspensionRegulatory 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 17/10/2016
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Cancellation or suspensionRegulatory 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 12/10/2016
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code (see Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations).As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The goods do not conform to a standard applicable to the goods.The goods have changed so they have become separate and distinct from the goods included in the ARTG., effective 12/10/2016
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Cancellation or suspensionRegulatory action due to As the sponsor did not provide sufficient information to substantiate that the kind of device was correctly classified, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the Register were correct, in a material particular., effective 12/10/2016
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.The goods do not conform to a standard applicable to the goods.The goods have changed so they have become separate and distinct from the goods included in the ARTG.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 19/08/2016
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Cancellation or suspensionRegulatory 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 18/07/2016
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 11/07/2016
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Cancellation or suspensionRegulatory action due to The goods have changed so they have become separate and distinct from the goods included in the ARTG.The goods do not conform to a standard applicable to the goods., effective 11/07/2016
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PM - Lung Complex (Cancelled from the ARTG under s.30(2)(ba), s.30(2)(aa) and s.30(2)(e) of the Act)
Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The goods do not conform to a standard applicable to the goods., effective 04/07/2016 -
Cancellation or suspensionRegulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA, failed to demonstrate the application of the appropriate conformity assessment procedures for devices of the kind and failed to provide sufficient information to demonstrate compliance with the Essential Principles., effective 29/06/2016
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA, failed to demonstrate the application of the appropriate conformity assessment procedures for devices of the kind and failed to provide sufficient information to demonstrate compliance with the Essential Principles., effective 29/06/2016
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations.The goods have changed so they have become separate and distinct from the goods included in the ARTG.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 15/06/2016
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