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

12 January 2021

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 221

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 March 2021
Section 19A approved medicine:

Carbimazole 5mg tablets (DAWA Ltd)


Medicine in short supply/unavailable:

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

Section 19A approval holder: Seed Pharma Pty Ltd ABN 81 612 154 373

Approval holder phone number: 1300 966 356

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.

Import and supply approved until: 19 June 2021
Section 19A approved medicine:

TECHNELITE Technetium (Tc-99m) Generator


Medicine in short supply/unavailable:

  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate - ARTG 72820
  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechneta - ARTG 75859
  • TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) - ARTG 130301

Section 19A approval holder: Global Medical Solutions Australia Pty Limited ABN 66 072 147 561

Approval holder phone number: 02 9503 8100

Technetium [99mTc] Generator is used for the preparation of Sodium Pertechnetate [99mTc] Injection.

Sodium Pertechnetate [99mTc] is used as an agent for:

  • Brain Imaging,
  • Thyroid Imaging,
  • Salivary Gland Imaging and
  • Blood Pool Imaging

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

EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (UK)


Medicine in short supply/unavailable:

  • EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL concentrated injection vial - ARTG 227997
  • PHARMORUBICIN epirubicin hydrochloride 200mg/100mL injection vial - ARTG 49746
  • EPIRUBICIN AN epirubicin hydrochloride 200 mg/100 mL concentrated injection vial - ARTG 146599

Section 19A approval holder: Accord Healthcare Pty Ltd ABN 49 110 502 513

Approval holder phone number: 1800 222 673

  • Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases. Epirubicin Hydrochloride injection is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma and superficial bladder cancer (Tis, Ta)

  • In bladder cancer, Epirubicin Hydrochloride injection is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (grade 2 and 3)
  • Import and supply approved until: 31 October 2021
    Section 19A approved medicine:

    Pethidine 100mg/2mL Solution for Injection, 2mL ampoule (Martindale)


    Medicine in short supply/unavailable:

    • DBL PETHIDINE HYDROCHLORIDE 100mg/2mL injection BP ampoule - ARTG 107387

    Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Pethidine 50 mg/mL Solution for Injection ampoules (50 mg/mL & 100 mg/2 mL) are approved for use under Section 19A for the following indications:

    • For short term (24 to 36 hours) management of severe pain

  • For administration as an anaesthetic adjunct and for obstetric analgesia
  • Import and supply approved until: 31 March 2021
    Section 19A approved medicine:

    PARNATE Tranylcypromine tablets USP 10mg (GSK)


    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: 30 April 2022
    Section 19A approved medicine:

    Famotidine 40mg 28 tablet blister pack - Tillomed


    Medicine in short supply/unavailable:

    • AUSFAM 40 famotidine 40mg tablet blister pack - ARTG 93789

    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: 30 April 2022
    Section 19A approved medicine:

    Famotidine 20mg 28 tablet blister pack - Tillomed


    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: 15 May 2021
    Section 19A approved medicine:

    Furosemid-ratiopharm (Furosemide) 500mg tablet


    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 500mg Furosemide tablets, 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: 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 .

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