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

20 November 2020

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 1 - 10 of 213

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 April 2021
Section 19A approved medicine:

Fluoxetine tablets USP 20mg (Dr Reddy's) 30 tablet bottle


Medicine in short supply/unavailable:

  • Prozac Fluoxetine 20mg tablets - ARTG 61081 - Discontinued
  • LOVAN TAB Fluoxetine (as hydrochloride) 20mg tablet blister pack - ARTG 61080

Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Treatment of Major depression and Obsessive Compulsive Disorder.

Import and supply approved until: 31 March 2021
Section 19A approved medicine:

NeoMercazole carbimazole 5mg tablets bottle of 50 (France)


Medicine in short supply/unavailable:

  • Carbimazole Neo-Mercazole 5mg tablets bottle of 100 - ARTG 194296

Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd

Approval holder phone number: 1800 627 680

Therapy of hyperthyroidism. Definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. Preparation for thyroidectomy. Before and after radioactive iodine treatment.

NeoMercazole carbimazole 5mg tablets bottle of 50 (France) is registered in France and the packaging and product leaflet contains text in the French language. Pharmacists are instructed to direct consumers to disregard the patient leaflet for NeoMercazole carbimazole 5mg tablets bottle of 50 (France) contained within the pack and refer to the Australian Consumer Medicines Information available from: https://www.tga.gov.au .

Import and supply approved until: 31 January 2021
Section 19A approved medicine:

Tranylcypromine sulfate 10mg film coated tablets (Alvogen Inc)


Medicine in short supply/unavailable:

  • PARNATE tranylcypromine (as sulphate) 10mg film coated tablet blister pack - ARTG 174086

Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Tranylcypromine sulfate is indicated for the treatment of symptoms of depressive illness especially where treatment with other types of antidepressants has failed. It is not recommended for use in mild depressive states resulting from temporary situational difficulties.

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

Desmopressin Acetate Nasal Solution (Nasal Spray) 10mcg/0.1mL per spray 5mL bottle (Zydus Pharmaceuticals)


Medicine in short supply/unavailable:

  • MINIRIN desmopressin acetate 10 microgram/ actuation nasal spray - ARTG 59320

Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

  • Diabetes Insipidus - The treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria

  • Nocturnal Enuresis - The symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. Desmopressin Acetate Nasal Solution (Nasal Spray) 10mcg/0.1mL per spray (Zydus Pharmaceuticals) should be used only in patients who are refractory to the enuresis alarm or in patients in whom enuresis alarm is contraindicated or inappropriate, and where the oral administration of desmopressin is not feasible
  • Renal Concentrating Capacity - By intranasal administration to adults and children as a diagnostic test to establish renal concentrating capacity
  • Import and supply approved until: 31 October 2021
    Section 19A approved medicine:

    Mebrofenin kit for the preparation of Technetium Tc 99m mebrofenin for injection (USA)


    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 Tc 99m Mebrofenin is indicated as an adjuct in the diagnosis of hepatobiliary disease.

    Import and supply approved until: 30 April 2021
    Section 19A approved medicine:

    Fluoxetine capsules USP 20mg (ScieGen) 100 capsule bottle


    Medicine in short supply/unavailable:

    • PROZAC 20 fluoxetine 20mg (as hydrochloride) capsule - ARTG 14653
    • LOVAN fluoxetine 20mg (as hydrochloride) capsule - ARTG 54700

    Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Treatment of Major depression and Obsessive Compulsive Disorder

    Import and supply approved until: 15 February 2021
    Section 19A approved medicine:

    TEVA-PRAZOSIN (Prazosin hydrochloride) 5mg tablets


    Medicine in short supply/unavailable:

    • MINIPRESS prazosin 5 mg (as hydrochloride) tablet blister pack - ARTG 10758

    Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    In Patients with Hypertension.

    Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.

    Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia

    Import and supply approved until: 15 February 2021
    Section 19A approved medicine:

    TEVA-PRAZOSIN (Prazosin hydrochloride) 2mg tablets


    Medicine in short supply/unavailable:

    • MINIPRESS prazosin 2 mg (as hydrochloride) tablet blister pack - ARTG 10757
    • APO-PRAZOSIN prazosin (as hydrochloride) 2mg tablet blister pack - ARTG 73862

    Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    In Patients with Hypertension.

    Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.

    Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia

    Import and supply approved until: 15 February 2021
    Section 19A approved medicine:

    TEVA-PRAZOSIN (Prazosin hydrochloride) 1mg tablets


    Medicine in short supply/unavailable:

    • MINIPRESS prazosin 1 mg (as hydrochloride) tablet blister pack - ARTG 10756

    Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    In Patients with Hypertension.

    Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.

    Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia

    Import and supply approved until: 31 January 2021
    Section 19A approved medicine:

    Tranexamic Acid 500mg tablets (TILLOMED) 60 tablets


    Medicine in short supply/unavailable:

    • CYCLOKAPRON tranexamic acid 500mg tablet bottle - ARTG 144653

    Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    • Hereditary angioneurotic oedema

  • Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery
  • Menorrhagia
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