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Australia: TGA authorizes overseas-registered contrast diagnostic agents to ease shortage

2022/06/23  TGA

The Therapeutic Goods Administration (TGA) is aware of a global shortage of iodinated contrast media (contrast) diagnostic agents. The TGA recommends urgent conservation of stock until the shortage is resolved as current supply is very limited.

Non-ionic contrast agent is used to enhance imaging in a wide range of diagnostic procedures in adults and children.

GE Healthcare, the sponsor of Omnipaque (iohexol) and Visipaque (iodixanol), has notified the TGA of a shortage of multiple presentations of both these products due to reduced manufacturing capacity and freight delays caused by the recent unexpected COVID-19 lockdown in Shanghai, China.

GE Healthcare is the largest supplier of contrast media in Australia and expects to resume normal supply in mid-July 2022. Any updates to the return to supply date will be published on the Medicine Shortage Reports Database.

In the meantime, the TGA is working with a range of stakeholders to manage the shortage including working with sponsors who are investigating the import and supply of overseas registered non-ionic contrast media agents under section 19A of the Therapeutic Goods Act 1989.

The TGA has worked with the Royal Australian and New Zealand College of Radiologists (RANZCR) to develop general guidance to assist health professionals to conserve stock urgently.

20 June 2022 Update:
To help reduce the impact of this shortage, the TGA has authorised the supply of multiple overseas-registered products under section 19A of the Therapeutic Goods Act 1989. For information on supply contact the following approval holders:

  • Guerbet Australia Pty Ltd on 02 8075 3007
  • Bayer Australia Pty Ltd on 1800 008 757
  • GE Healthcare Australia Pty Ltd on 1300 887 764

Information regarding the approval of overseas-registered product under section 19A of the Therapeutic Goods Act 1989 is published on the Database of section 19A approvals.

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