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
- Medical device cancellation (851)
- Medicine suspension (506)
- Complementary medicine cancellation (205)
- Medical device suspension (87)
- Medicine cancellation (59)
- Revocation of a TGA issued Conformity Assessment Certificate (55)
- Medical device cancellation - certain devices within an entry (23)
- Voluntary revocation at the request of the manufacturer (18)
- Registered medicine cancellation (14)
- Medical device cancellation - requested by the sponsor - certain devices within an entry (8)
- Medical device cancellation (7)
- Listed medicine cancellation (4)
- Listed medicine cancellation (4)
- Revocation of a TGA issued Conformity Assessment Certificate. (3)
- Revocation of medical device suspension (3)
- Revoked medicine suspension (2)
- AFT Pharmaceuticals Pty Ltd (1)
- Alphapharm Pty Ltd (1)
- Complementary Medicine Cancellation (1)
- Complementary medicine cancellation (1)
- Medical device cancellation (1)
- Suspension from the ARTG under subsection s41GA(1)(b) (1)
- Voluntary revocation at the request of the manufacturer. (1)
Find out more about Cancellations and Suspensions.
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Cancellation or suspensionCancellation from the ARTG under subsection 41GN(1) of the Act.
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Cancellation or suspensionCancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act
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Cancellation or suspensionCancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.
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Cancellation or suspensionThe sponsor did not provide sufficient 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, and the certifications made are incorrect, or are no longer correct, in a material particular.
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Cancellation or suspensionCancellation from the ARTG under subsection 41GN(1)(b) of the Act
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Cancellation or suspensionThe sponsor did not provide sufficient 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.
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Cancellation or suspensionRegulatory action taken as it appears to the Secretary that the presentation of the goods is unacceptable (paragraph 30(2)(aa) of the Act).
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 31/07/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 31/07/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 02/08/2024
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Cancellation or suspensionThe sponsor did not provide sufficient 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.
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Cancellation or suspensionThe sponsor did not provide sufficient 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.
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Cancellation or suspensionThe sponsor did not provide sufficient 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.
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Cancellation or suspensionThe sponsor did not provide sufficient 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.
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Cancellation or suspensionThe medicine is not eligible for listing (paragraph 30(1A)(a) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act). -
Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 30/05/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 07/05/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 27/02/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 07/05/2024
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer, effective 14/06/2024
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Cancellation or suspensionWe have suspended Portable ventilator, electric/47083: BiPAP A40 EFL - AUX3000S19 from the ARTG under subsection s41GA(1)(b)
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Cancellation or suspensionWe have suspended Portable ventilator, electric/47083: BiPAP A40 Pro - AUX3100S19 from the ARTG under subsection s41GA(1)(b)
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Cancellation or suspensionWe have suspended Portable ventilator, electric/47083: OmniLab Advanced+ International w/Humidifer – 1111126 OmniLab Advanced+ International w/Heated Tube Humidifier - 1111127, Suspension from the ARTG under subsection s41GA(1)(b) from the ARTG under subsection s41GA(1)(b)
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Cancellation or suspensionWe have suspended Positive airway pressure unit, bi-level/36990: BiPAP A30 Australia Silver Series – 1111145 BiPAP A30 Australia – 1076581 BiPAP A30 Australia, Core Package - 1076582 from the ARTG under subsection s41GA(1)(b)
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Cancellation or suspensionWe have suspended Positive airway pressure unit, bi-level/36990: BiPAP A40, Australia - 1076583 BiPAP A40 Australia Silver Series - 1111171 from the ARTG under subsection s41GA(1)(b)