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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1889 result(s) found, displaying 1576 to 1600
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to It appeared to the Secretary that the presentation of the goods was unacceptable.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., effective 10/08/2018
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 06/08/2018
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Cancellation or suspensionRegulatory action due to The certifications made by the sponsor under section 41FD in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN(3)., effective 06/08/2018
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Cancellation or suspensionRegulatory action due to The goods do not conform to a standard applicable to the goods., effective 05/07/2018
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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 04/07/2018
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 22/06/2018
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they did not meet the requirements set out in Schedule 4 of the Therapeutic Goods Regulations.The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018
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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 20/04/2018
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Cancellation or suspensionRegulatory action due to Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling this ARTG entry, in accordance with subsection 41GN(1)(b) of the Act. The suspension from the ARTG was effective on 5 April 2018 for a period of six months., effective 05/04/2018
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Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 03/04/2018
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Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 03/04/2018
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Cancellation or suspensionRegulatory action due to As it appeared to the Secretary that the presentation of the goods was unacceptable, the certification made under s.26A(2)(c) of the Act was incorrect.The goods do not conform to a standard applicable to the goods., effective 06/03/2018
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Cancellation or suspensionRegulatory action due to The Device has been cancelled as the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked. The sponsor did not provide evidence that the device complies with Essential Principles 1 and 6 prior to the expiry of the suspension period.The grounds for cancellation apply only to SerenoCem Granules BCG050 (the Device) and the cancellation is limited under s41GO to vary ARTG 152441 accordingly., effective 28/02/2018
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Cancellation or suspensionRegulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018
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Cancellation or suspensionRegulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 24/01/2018
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply 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 17/01/2018
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