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Database of section 19A approvals to import and supply medicines to address medicine shortages

4 August 2022

This database provides information on medicines not on the Australian Register of Therapeutic Goods (ARTG) that are approved for import and supply in Australia because:

  • there is a shortage of a medicine registered in Australia; and
  • the medicine is needed in the interest of public health.

The database holds information on approvals current on or after 21 Feburary 2018. Contact the TGA's Medicines Shortages Section for information on approvals that expired or lapsed before 21 Feburary 2018.

Consumers can use medicines accessed under section 19A until the medicines expire.

The 'Import and supply approved until' date applies to the approval holder importing and supplying the medicine.

The Medicines Shortages Information Initiative lists medicines that are unavailable or in short supply. If you are having difficulty obtaining a treatment that has been prescribed to you, talk to your doctor or pharmacist.

Section 19A approvals are granted for a specified period, which usually coincides with the period that the medicine on the ARTG is unavailable or in short supply. However, approval may lapse early if:

  • a decision has been made about whether or not to register the medicine in Australia
  • any of the specific criteria for approval no longer apply (for example, the registered medicine is no longer in short supply)
  • a condition of approval has been breached.

Section 19A approvals are subject to a number of conditions specified by the TGA including the following (though additional conditions can be imposed where the circumstances warrant it):

  • the approval applies only to the medicine specified in the approval
  • the approval is only for importation into and supply within Australia
  • the medicine is sourced from manufacturers with acceptable evidence of Good Manufacturing Practice (GMP)
  • a letter to health professionals who will be prescribing the medicine is usually required
  • the goods must be labelled with the name and address of the approval holder to ensure that adverse events can be reported.

Section 19A approvals

Displaying 31 - 40 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 28 February 2023
Section 19A approved medicine:

ULTRAVIST 300 iopromide 62.34g/100mL (equivalent to 300 mg/1 mL of organically bound iodine) solution for injection (Vietnam)


Medicine in short supply/unavailable:

  • non - ionic CONTRAST MEDIA SHORTAGE

Section 19A approval holder: Bayer Australia Ltd ABN: 22 000 138 714

Approval holder phone number: 1800 008 757

ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography.

Import and supply approved until: 28 February 2023
Section 19A approved medicine:

XENETIX 350 iobitridol 76.78g (767.8mg/mL) corresponding to iodine 350mg/mL solution for injection (Singapore)


Medicine in short supply/unavailable:

  • non - ionic CONTRAST MEDIA SHORTAGE

Section 19A approval holder: Guerbet Australia Pty Ltd ABN: 15 159 798 302

Approval holder phone number: 02 8075 3007

XENETIX 350 iobitridol 76.78g (767.8mg/mL) corresponding to iodine 350mg/mL solution for injection (Singapore) is for diagnostic use only.

Contrast agent to be used in adults for:

  • Intravenous urography
  • intravenous digital subtraction angiography
Import and supply approved until: 28 February 2023
Section 19A approved medicine:

ULTRAVIST 300 iopromide 31.17g/50mL (equivalent to 300 mg/1 mL of organically bound iodine) solution for injection (Vietnam)


Medicine in short supply/unavailable:

  • non - ionic CONTRAST MEDIA SHORTAGE

Section 19A approval holder: Bayer Australia Ltd ABN: 22 000 138 714

Approval holder phone number: 1800 008 757

ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography.

Import and supply approved until: 29 August 2022
Section 19A approved medicine:

EUROFOLIC folinic acid 50mg/5mL solution for injection (Germany)


Medicine in short supply/unavailable:

  • DBL LEUCOVORIN CALCIUM folinic acid 50 mg/5 mL (as calcium folinate) injection USP vial (NF) AUST R: 42148

Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

Import and supply approved until: 31 July 2022
Section 19A approved medicine:

Cidofovir 375mg/5mL injection for IV infusion vial (Heritage)


Medicine in short supply/unavailable:

  • EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vial AUST R: 287040

Section 19A approval holder: Orspec Pharma Pty Ltd ABN: 15 634 980 417

Approval holder phone number: 02 4339 4239

Cidofovir is indicated in adults for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Import and supply approved until: 31 May 2023
Section 19A approved medicine:

OPTIRAY 320 Ioversol 678mg/mL (equivalent to 320 mg of organically bound iodine) sterile solution for injection - 100 mL prefilled syringe (Canada)


Medicine in short supply/unavailable:

  • non - ionic CONTRAST MEDIA SHORTAGE

Section 19A approval holder: Guerbet Australia Pty Ltd ABN: 15 159 798 302

Optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. These include cerebral, coronary, peripheral,visceral and renal arteriography, aortography, left ventriculography and venography. OPTIRAY may be used for intravenous excretory urography.

OPTIRAY 320 is indicated in children (excluding neonates) for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Import and supply approved until: 31 March 2023
Section 19A approved medicine:

IXIARO Japanese encephalitis vaccine (inactivated, adsorbed) suspension for injection pre-filled syringe


Medicine in short supply/unavailable:

  • JESPECT japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe (AUST R 150602)

Section 19A approval holder: Seqirus Australia Pty Ltd ABN 66 120 398 067

Approval holder phone number: 1800 008 275

JESPECT® is indicated for active immunisation against Japanese Encephalitis (JE) virus for persons 18 years of age and older.

Import and supply approved until: 31 March 2022
Section 19A approved medicine:

(Approval lapsed) Heparin Sodium Injection USP 5000 units/mL solution (McKesson/SKY)


Medicine in short supply/unavailable:

  • DBL HEPARIN SODIUM 5000IU/1mL (porcine mucous) Injection BP - AUSTR 1288

Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Heparin is indicated for the prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism and occlusive vascular disease. It is also used to prevent thromboembolic complications arising from cardiac and vascular surgery, frostbite, dialysis and other perfusion procedures. Heparin is also used as an anticoagulant in blood transfusions.

Import and supply approved until: 31 August 2022
Section 19A approved medicine:

NOPIL fur Kinder Sirup - sulfamethoxazole and trimethoprim 200 mg/40 mg oral syrup 100 mL bottle


Medicine in short supply/unavailable:

  • SEPTRIN sugar-free oral liquid bottle AUST R: 11000

Section 19A approval holder: Orspec Pharma Pty Ltd ABN 15 634 980 417

Approval holder phone number: 02 4339 4239

Upper and lower respiratory tract infections; renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias, and other infections caused by sensitive organisms.

Import and supply approved until: 31 October 2022
Section 19A approved medicine:

IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (International presentation)


Picture of IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (International presentation) - Carton
Picture of IMOJEV (International presentation) - diluent label
Picture of IMOJEV (International presentation) - vial label

Medicine in short supply/unavailable:

  • IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial AUST R: 162215

Section 19A approval holder: Sanofi-Aventis Australia Pty Ltd ABN 31 008 558 807

Approval holder phone number: 1800 818 806

Indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.

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