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 1751 to 1775
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Device Technologies Australia Pty Ltd - Skin expander (Suspension from the ARTG under s.41GA (1)(b))
Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015 -
Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months., effective 20/11/2015
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Cancellation or suspensionRegulatory action due to The goods have changed so that 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 30/10/2015
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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.As the information included in or with the application was incorrect, the certification made under s.26A(2)(k) of the Act was incorrect., effective 27/10/2015
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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 01/10/2015
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IL HWA CONCENTRATED GINSENG TEA Liquid Extract (Cancelled from the ARTG under s.30(2)(e) of the Act)
Cancellation or suspensionRegulatory action due to The goods do not conform to a standard applicable to the goods., effective 22/09/2015 -
Cancellation or suspensionRegulatory action due to The sponsor failed to comply within 14 days after the end of the period specified in a notice under section 31 requiring it to provide information or documents relating to the goods., effective 22/09/2015
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Cancellation or suspensionRegulatory action due to The goods have changed so that they have become separate and distinct from the goods included in the ARTG.As it appeared to the Secretary that the presentation of the goods was unacceptable, the certification made under s.26A(2)(c) was incorrect.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect.The goods do not conform to a standard applicable to the goods., effective 25/08/2015
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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) was incorrect.The goods do not conform to a standard applicable to the goods., effective 25/08/2015
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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 19/08/2015
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Cancellation or suspensionRegulatory action due to Cancelled on the basis that the Secretary is satisfied that the safety and performance of the kind of device is unacceptable., effective 14/08/2015
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Cancellation or suspensionRegulatory action due to The Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: TiLOOP Tape; TiLOOP Two; TiLOOP Total 4; TiLOOP Total 6; TiLOOP Fix; TiLOOP Mesh; TiLOOP Patch; and TiLOOP Clip., effective 12/08/2015
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Cancellation or suspensionRegulatory action due to The Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude this device: Selexys Acetabular Component TPS and TH+., effective 07/08/2015
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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) was incorrect.The sponsor failed to comply with a condition of listing under s.28(5)(ab) (that the goods would not be advertised for an indication other than those accepted in the Register).The goods do not conform to a standard applicable to the goods.The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 18/06/2015
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Cancellation or suspensionRegulatory action due to As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 29/05/2015
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Cancellation or suspensionRegulatory action due to As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 08/05/2015
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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 that exceeded the maximum daily dose of that substance prescribed for listed medicines in Division 2 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations (see item 3, Part 1 of Schedule 4)., effective 05/05/2015
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