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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 61 - 70 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 April 2022
Section 19A approved medicine:

(Approval lapsed) Famotidine 20mg 28 tablet blister pack - Tillomed


Picture of Famotidine 20mg 28 tablet blister pack - Tillomed - carton label

Medicine in short supply/unavailable:

  • APO-FAMOTIDINE famotidine 20mg tablet blister pack - ARTG 91513

Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 517

Approval holder phone number: 1800 181 060

  • Duodenal ulcer
  • Benign gastric ulcer
  • Zollinger-Ellison syndrome
  • Prevention of relapses of duodenal ulceration
  • Short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures

  • Healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease
  • Prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease
  • Import and supply approved until: 14 June 2021
    Section 19A approved medicine:

    (Approval lapsed) Furosemid-ratiopharm furosemide 500mg tablet (Germany)


    Picture of Furosemid-ratiopharm (Furosemide) 500mg tablet - carton label

    Medicine in short supply/unavailable:

    • UREX FORTE furosemide (frusemide) 500 mg tablet blister pack - ARTG 196972

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

    Approval holder phone number: 1300 788 261

    Furosemide (Frusemide) in a high-dosage formulation is intended exclusively for patients with severely impaired renal function. For use under strict medical supervision only within a hospital setting (see Dosage and Administration). High doses of frusemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, e.g. in the post-operative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the pre-dialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with the nephrotic syndrome with severe impairment of renal function e.g. in chronic glomerulonephritis, lupus erythematous and Kimmelstiel-Wilson syndrome. If diuresis is less than 2.5 L / day dialysis has to be used.

    Furosemid-ratiopharm furosemide 500mg tablet (Germany), is registered and marketed in Germany by ratiopharm GmbH and therefore all labelling is in German. Pharmacists are instructed to direct consumers to disregard the patient leaflet 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 March 2021
    Section 19A approved medicine:

    (Approval lapsed) NeoMercazole carbimazole 5mg tablets bottle of 50 (France)


    Picture of NeoMercazole carbimazole 5mg tablets bottle of 50 (France) - carton label
    Picture of NeoMercazole carbimazole 5mg tablets bottle of 50 (France) - bottle label

    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: 30 April 2021
    Section 19A approved medicine:

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


    Picture of Fluoxetine tablets USP 20mg (Dr Reddy's) 30 tablet bottle - bottle label

    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 January 2021
    Section 19A approved medicine:

    (Approval lapsed) Tranylcypromine sulfate 10mg film coated tablets (Alvogen Inc)


    Picture of Tranylcypromine sulfate 10mg film coated tablets (Alvogen Inc) - bottle label

    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:

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


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

    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: 15 February 2021
    Section 19A approved medicine:

    TEVA-PRAZOSIN (Prazosin hydrochloride) 1mg tablets


    Picture of TEVA-PRAZOSIN (Prazosin hydrochloride) 1mg tablets - bottle label

    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 August 2021
    Section 19A approved medicine:

    (Approval lapsed) TEVA-PRAZOSIN (Prazosin hydrochloride) 2mg tablets


    Picture of TEVA-PRAZOSIN (Prazosin hydrochloride) 2mg tablets - bottle label

    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: 31 May 2021
    Section 19A approved medicine:

    (Approval lapsed) TEVA-PRAZOSIN (Prazosin hydrochloride) 5mg tablets


    Picture of TEVA-PRAZOSIN (Prazosin hydrochloride) 5mg tablets - bottle label

    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: 30 April 2021
    Section 19A approved medicine:

    (Approval Lapsed) Fluoxetine capsules USP 20mg (ScieGen) 100 capsule bottle


    Picture of Fluoxetine capsules USP 20mg (ScieGen) 100 capsule bottle - bottle label

    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

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