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

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.
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Section 19A approvals

Displaying 1 - 10 of 37

Enter a approval holder, product name, active ingredient, indication or ARTG number.

Section 19A approved medicine:

Heparin Natrium 5000 Ratiopharm (5000 IU/0.2mL heparin sodium) ampoules

Import and supply approved until: 15 October 2018

Medicine in short supply/unavailable:

  • DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2mL injection BP ampoule - ARTG 16349

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.

Section 19A approved medicine:

BCG 10 Anti-Tuberculosis Vaccine powder and solvent for suspension for intradermal injections (0.5 mg (from 1.5 mln to 6 mln) of live BCG bacilli (Bacillus Calmette-Guerin) the Brazilian Moreau Substrain)

Import and supply approved until: 28 February 2019

Medicine in short supply/unavailable:

  • BCG VACCINE Mycobacterium bovis (Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) (BCG) strain) 1.5mg powder for injection multidose vial with diluent vial - ARTG 53569

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

BCG 10 Anti-Tuberculosis Vaccine is recommended for active immunisation in high risk groups.

Section 19A approved medicine:

DANTRIUM (dantrolene sodium) 25mg capsules [Norgine]

Import and supply approved until: 20 April 2019

Medicine in short supply/unavailable:

  • DANTRIUM dantrolene sodium hemiheptahydrate 25mg capsule bottle - ARTG 42975
  • DANTRIUM dantrolene sodium hemiheptahydrate 50mg capsule bottle - ARTG 42976

Section 19A approval holder:

Pfizer Australia Pty Ltd ABN 50 008 422 348

Approval holder phone number: 1800 675 229

Dantrium capsules are indicated for the treatment of chronic, severe spasticity of skeletal muscle in adults.

Section 19A approved medicine:

ZOLEDRONIC ACID 4mg/5mL Concentrate for Solution for Infusion (Claris Lifesciences)

Import and supply approved until: 31 October 2018

Medicine in short supply/unavailable:

  • APO-Zoledronic Acid 4mg/5mL concentrated injection vial - ARTG 190337

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

* Prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in adult patients with advanced malignancies involving bone. * Treatment of adult patients with tumour-induced hypercalcaemia.

Section 19A approved medicine:

HYMENOPTERA VENOM PRODUCT - Wasp Venom Protein (550 MCG) powder for solution

Import and supply approved until: 29 May 2019

Medicine in short supply/unavailable:

  • ALBEY PAPER WASP VENOM paper wasp venom protein 550 microgram powder for injection vial with 4 vials of diluent - ARTG 18695

Section 19A approval holder:

Stallergenes Australia Pty Ltd ABN 17 151 366 540

Approval holder phone number: 1800 824 166

For the diagnosis and treatment of hypersensitivity to wasp venom.

Section 19A approved medicine:

HYMENOPTERA VENOM PRODUCT – Yellow Jacket Venom Protein (550 MCG) powder for solution

Import and supply approved until: 29 May 2019

Medicine in short supply/unavailable:

  • ALBEY YELLOW JACKET VENOM TREATMENT SET With Albey Albumin Saline Diluent - ARTG 18770

Section 19A approval holder:

Stallergenes Australia Pty Ltd ABN 17 151 366 540

Approval holder phone number: 1800 824 166

For the diagnosis and treatment of hypersensitivity to yellow jacket venom.

Section 19A approved medicine:

HEPATOLITE kit for the preparation of technetium Tc99m Disofenin for injection

Import and supply approved until: 31 August 2018

Medicine in short supply/unavailable:

  • HEPATOLITE kit for production of Technetium(99mTc) disofenin powder for injection multidose vial - ARTG 19146

Section 19A approval holder:

Global Medical Solutions T/A Radpharm Scientific ABN 66 072 147 561

Approval holder phone number: 02 9503 8100

Technetium Tc99m Disofenin is indicated as an adjunct in the diagnosis of hepatobiliary disease.

Section 19A approved medicine:

PRENOXAD 1mg/mL Solution for Injection in a pre-filled syringe (naloxone hydrochloride)

Import and supply approved until: 31 March 2019

Medicine in short supply/unavailable:

  • MIN-I-JET NALOXONE 400microgram/1mL injection syringe - ARTG 29051

Section 19A approval holder:

Phebra Pty Ltd ABN 77 695 661 635

Approval holder phone number: 02 9420 9199

Prenoxad Injection is intended for the complete or partial reversal of respiratory depression induced by natural and synthetic opioids. It may also be used for the diagnosis of suspected acute opioid overdose.

Section 19A approved medicine:

METOPROLOL CARINO (metoprolol tartrate) 1mg/mL solution for injection, 5mL ampoule

Import and supply approved until: 15 May 2018

Medicine in short supply/unavailable:

  • BETALOC Metoprolol tartrate 5mg/5mL injection ampoule

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Intravenous therapy - disturbances of cardiac rhythm, in particular supraventricular tachyarrhythmias.

Section 19A approved medicine:

Dantrium Intravenous 20 mg dantrolene sodium Powder for Solution for Injection

Import and supply approved until: 15 May 2018

Medicine in short supply/unavailable:

  • DANTRIUM dantrolene sodium hemiheptahydrate 20mg powder for injection vial - ARTG 14435

Section 19A approval holder:

Pfizer Australia Pty Ltd ABN 50 008 422 348

Approval holder phone number: 1800 675 229

For the treatment of malignant hyperthermia.

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