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

9 October 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 67

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

Section 19A approved medicine:

SINEMET CR 50 mg/200 mg (carbidopa /levodopa) Prolonged-Release Tablets

Import and supply approved until: 31 January 2019

Medicine in short supply/unavailable:

  • SINEMET CR levodopa/carbidopa 200mg/50mg modified release tablet bottle - ARTG 171694

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited with Sinemet CR in patients who have not been treated with levodopa before.

Section 19A approved medicine:

ILEVRO (nepafenac ophthalmic suspension), 0.3%

Import and supply approved until: 28 February 2019

Medicine in short supply/unavailable:

  • ILEVRO nepafenac 0.3% eye drops, suspension, bottle - ARTG 230200

Section 19A approval holder:

Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

  • Prevention and treatment of postoperative pain and inflammation associated with cataract surgery

  • Reduction in risk of postoperative macular oedema associated with cataract surgery in patients with non-proliferative diabetic retinopathy

  • Section 19A approved medicine:

    VERSACLOZ (clozapine) 50 mg/mL oral suspension (TruPharma)

    Import and supply approved until: 30 April 2019

    Medicine in short supply/unavailable:

    • CLOPINE SUSPENSION clozapine 50 mg/mL oral liquid bottle - ARTG 142239

    Section 19A approval holder:

    Pfizer Australia Pty Ltd ABN 50 00 8422 348

    Approval holder phone number: 1800 675 229

    Treatment with VERSACLOZ is indicated only in people with treatment-resistant schizophrenia, ie. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.

    Section 19A approved medicine:

    Fentanyl 50 micrograms/mL Solution for Injection, 100mcg/2mL ampoules

    Import and supply approved until: 30 November 2018

    Medicine in short supply/unavailable:

    • ASPEN FENTANYL fentanyl (as citrate) 100 microgram/2 mL solution for injection - ARTG 170929

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

  • Short duration analgesia during premedication, induction and maintenance of anaesthesia, and in the immediate postoperative period.

  • Opioid analgesic supplement to general and regional anaesthesia.

  • Combination with a neuroleptic as an anaesthetic premedication for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

  • Section 19A approved medicine:

    Fentanyl 50 micrograms/mL Solution for Injection, 500mcg/10mL ampoules

    Import and supply approved until: 30 November 2018

    Medicine in short supply/unavailable:

    • ASPEN FENTANYL fentanyl (as citrate) 500 microgram/10 mL solution for injection - ARTG 170931

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

  • Short duration analgesia during premedication, induction and maintenance of anaesthesia, and in the immediate postoperative period.

  • Opioid analgesic supplement to general and regional anaesthesia.

  • Combination with a neuroleptic as an anaesthetic premedication for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

  • Section 19A approved medicine:

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

    Import and supply approved until: 15 December 2018

    Medicine in short supply/unavailable:

    • SEPTRIN sugar-free oral liquid bottle -ARTG 11000

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Infections caused by microorganisms that are susceptible to sulfamethoxazole and trimethoprim, such as upper and lower respiratory tract infections; renal and urinary tract infections; genital tract infections; gastrointestinal tract infections, and other infections caused by sensitive organisms.

    Section 19A approved medicine:

    AciVision (aciclovir) 30mg/g eye ointment

    Import and supply approved until: 31 August 2019

    Medicine in short supply/unavailable:

    • ZOVIRAX ophthalmic aciclovir 30mg/g ointment tube - ARTG 11013

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Treatment of herpes simplex keratitis.

    Section 19A approved medicine:

    Moxifloxacin 400 mg Film-coated Tablets

    Import and supply approved until: 31 January 2019

    Medicine in short supply/unavailable:

    • AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack - ARTG 75766

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    For the treatment of adults with infections caused by susceptible organisms in the conditions:

  • Acute bacterial sinusitis

  • Community acquired pneumonia

  • Acute exacerbations of chronic bronchitis

    Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with Avelox may be initiated, in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy.

    Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

  • 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:

    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.

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