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

Database of section 19A approvals to import and supply medicines during a shortage

5 September 2018

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 59

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

Section 19A approved medicine:

PHENOXYBENZAMINE 10mg capsules, 30 capsules

Import and supply approved until: 30 June 2019

Medicine in short supply/unavailable:

  • DIBENYLINE phenoxybenzamine hydrochloride 10mg capsule jar - ARTG 12980

Section 19A approval holder:

Amdipharm Mercury (Australia) Pty Ltd ABN 91 118 1 06 684

Approval holder phone number: 1800 627 680

Hypertensive episodes associated with Phaeochromocytoma.

Section 19A approved medicine:

Sterile Diluent For Allergenic Extracts With Human Serum Albumin (HSA)

Import and supply approved until: 1 August 2019

Medicine in short supply/unavailable:

  • ALBUMIN-SALINE diluent - ARTG 32486

Section 19A approval holder:

Stallergenes Australia Pty Ltd ABN 17 151 366 540

Approval holder phone number: 1800 824 166

Diluent for subcutaneous injection - to be used for dilution of venom products only

Section 19A approved medicine:

ERGONOVINE MALEATE INJECTION (Ergonovine Maleate Injection, USP) 0.25 mg/mL, 1 mL ampoules

Import and supply approved until: 31 January 2019

Medicine in short supply/unavailable:

  • DBL ERGOMETRINE INJECTION Ergometrine maleate injection - ARTG 58866

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Prevention or treatment of postpartum or post-abortal hemorrhage due to uterine atony.

Section 19A approved medicine:

Ethambutol (ethambutol hydrochloride) 100mg Tablets, 56 tablet blister

Import and supply approved until: 15 August 2019

Medicine in short supply/unavailable:

  • MYAMBUTOL ethambutol hydrochloride 100mg tablet bottle - ARTG 47887

Section 19A approval holder:

Orpharma Pty Ltd ABN 19 157 901 267

Approval holder phone number: 03 9863 7501

ETHAMBUTOL (ethambutol hydrochloride) 100 MG TABLET is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies.

Section 19A approved medicine:

AMILORIDE 5mg Tablets, 28 tablet blister pack

Import and supply approved until: 30 November 2018

Medicine in short supply/unavailable:

  • KALURIL amiloride hydrochloride dihydrate 5mg tablet bottle - ARTG 17652

Section 19A approval holder:

HL Pharma Pty Ltd ABN 31 168 013 723

Approval holder phone number: 03 9823 6228

Potassium-conserving agent; diuretic.

Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics in order to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy.

In congestive heart failure, Amiloride Hydrochloride may be effective alone, but its principal indication is for concomitant use in patients receiving thiazides or more potent diuretic agents.

In hypertension, it is used as an adjunct to prolonged therapy with thiazides and similar agents to prevent potassium depletion.

In hepatic cirrhosis with ascites, Amiloride Hydrochloride usually provides adequate diuresis, with diminished potassium loss and less risk of metabolic alkalosis, when used alone. It may be used with more potent diuretics when a greater diuresis is required while maintaining a more balanced serum electrolyte pattern.

Section 19A approved medicine:

EURO-K 600 Potassium Chloride 600mg Sustained Release Tablets USP, 100 and 500 tablets bottle

Import and supply approved until: 30 November 2018

Medicine in short supply/unavailable:

  • SPAN K potassium chloride 600mg tablet bottle - ARTG 27978
  • SLOW-K potassium chloride 600mg tablet (reformulation 2) jar - ARTG 76769
  • DURO-K potassium chloride 600mg tablet jar - ARTG 79739

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Treatment of all types of potassium deficiencies, particularly hypochloraemic or hypokalaemic alkalosis associated with prolonged or intensive diuretic therapy, eg. in hypertension, cardiac failure or massive oedema (potassium replacement is particularly important to patients receiving digitalis, as the clinical response to this drug is seriously affected by hypokalaemia), in renal disease associated with increased potassium excretion eg. nephrotic syndrome; vomiting and diarrhoea, ulcerative colitis, steatorrhoea, diabetes insipidus, and uncontrolled diabetes mellitus; ileostomy or colostomy patients, cirrhosis; Cushing's syndrome and dietary insufficiency; during prolonged or intensive treatment with corticosteroids, ACTH or carbenoxolone; hyperaldosteronism in megaloblastic anaemia, during the early stages of treatment. If a diet rich in potassium cannot be guaranteed.

Section 19A approved medicine:

Dilute Adrenaline (Epinephrine) 1:10,000 Injection, 1mg/10mL ampoule

Import and supply approved until: 31 October 2018

Medicine in short supply/unavailable:

  • ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP ampoule - ARTG 119194
  • ASPEN ADRENALINE INJECTION adrenaline (epinephrine) 1 mg/10 mL solution for injection ampoule - ARTG 162463

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

as an adjunct in the management of cardiac arrest

Section 19A approved medicine:

Heparin sodium 1,000 I.U./mL solution for injection or concentrate for solution for infusion, 5mL ampoules (5,000 I.U./5mL)

Import and supply approved until: 30 September 2018

Medicine in short supply/unavailable:

  • HEPARIN SODIUM 5000IU/5mL (porcine mucous) injection ampoule - ARTG 49232

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

In extracorporeal circulation and haemodialysis.

Section 19A approved medicine:

Heparin Sodium 10 I.U./mL flushing solution for maintenance of patency of intravenous devices (50 I.U. in 5mL)

Import and supply approved until: 14 November 2018

Medicine in short supply/unavailable:

  • HEPARINISED SALINE 50IU/5mL (porcine mucous) injection ampoule - ARTG 66684

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Maintenance of the patency of intravenous injection devices.

Section 19A approved medicine:

COTRIM-RATIOPHARM 480mg/5mL (sulfamethoxazole 400 mg/trimethoprim 80 mg) 5mL ampoules

Import and supply approved until: 31 October 2018

Medicine in short supply/unavailable:

  • DBL SULFAMETHOXAZOLE 400 mg AND TRIMETHOPRIM 80 mg CONCENTRATE INJECTION BP 5mL injection ampoule - ARTG 16293

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Parenteral administration of is indicated where oral dosage is not desirable or practical, e.g. pre- and post-operative infections associated with surgery, trauma or gynaecology; septicaemia and other infections due to sensitive organisms such as typhoid and paratyphoid.

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