Cancellations requested by the sponsor - regulatory actions

Sponsors can submit requests to cancel entries in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Act 1989 (the Act) requires the TGA to publish information on the Secretary’s decision to action these cancellations.

The cancellation provisions relating to cancellations requested by the sponsor in the Act are:

  • cancellation of listed or registered therapeutic goods: section 30(1)(c)
  • cancellation of biologicals: section 32GA(1)(d)
  • cancellation of medical devices: section 41GL(d).

The records below include information on the cancellation decisions and any subsequent decisions to revoke such cancellations. To find out whether a product is currently authorised for supply in Australia, check the ARTG.

Enter a product name or an ARTG number.

Cancellations

Displaying 1 - 10 of 8864

Merck Sharp & Dohme Australia Pty Ltd

Product: MAXALT rizatriptan (as benzoate) 10mg tablet blister pack

ARTG number: 69075

Type of decision: Cancelled under s30(1)(c)

Date of effect: 27 Jan 2017

Merck Sharp & Dohme Australia Pty Ltd

Product: MAXALT rizatriptan (as benzoate) 5mg tablet blister pack

ARTG number: 69074

Type of decision: Cancelled under s30(1)(c)

Date of effect: 27 Jan 2017

Ascensia Diabetes Care Australia Pty Ltd

Product: Ascensia Diabetes Care Australia Pty Ltd - Self-care monitoring web-based application software

ARTG number: 284577

Type of decision: Cancelled under s41GL(d)

Date of effect: 27 Jan 2017

Centre for Eye Health

Product: Centre for Eye Health - Ophthalmic refractometer, automatic

ARTG number: 165984

Type of decision: Cancelled under s41GL(d)

Date of effect: 27 Jan 2017

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Product: Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaPty Ltd - MRI system, application program software

ARTG number: 165390

Type of decision: Cancelled under s41GL(d)

Date of effect: 27 Jan 2017

Apotex Pty Ltd

Product: APO-OMEPRAZOLE omeprazole 20 mg tablet bottles

ARTG number: 193617

Type of decision: Cancelled under s30(1)(c)

Date of effect: 25 Jan 2017

Apotex Pty Ltd

Product: TERRY WHITE CHEMISTS OMEPRAZOLE omeprazole 20 mg tablet blister pack

ARTG number: 190948

Type of decision: Cancelled under s30(1)(c)

Date of effect: 25 Jan 2017

Apotex Pty Ltd

Product: CHEMMART OMEPRAZOLE omeprazole 20 mg tablet blister pack

ARTG number: 190947

Type of decision: Cancelled under s30(1)(c)

Date of effect: 25 Jan 2017

Apotex Pty Ltd

Product: APO-OMEPRAZOLE omeprazole 20 mg tablet blister pack

ARTG number: 190946

Type of decision: Cancelled under s30(1)(c)

Date of effect: 25 Jan 2017

Helena Laboratories Australia Pty Ltd

Product: Helena Laboratories Australia Pty Ltd - Instrument/analyser IVDs

ARTG number: 254914

Type of decision: Cancelled under s41GL(d)

Date of effect: 25 Jan 2017

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