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

17 September 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 194

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 November 2020
Section 19A approved medicine:

Suxamethonium Chloride 50mg/ml Solution for injection 10x2mL Ampoules (Martindale Pharmaceuticals UK)


Medicine in short supply/unavailable:

  • SUXAMETHONIUM JUNO 100mg/2mL injection ampoule - ARTG 32067

Section 19A approval holder: Juno Pharmaceuticals Pty Ltd ABN 55 156 303 650

Approval holder phone number: 03 8888 1288

For the production of skeletal muscle relaxation in anaesthesia. Suited for procedures requiring only brief relaxation such as endotracheal intubation, endoscopic examinations, orthopaedic manipulations, short surgical procedures and electro-convulsive therapy.

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

TRANEXAMIC ACID (Tranexamic acid) 500MG TABLETS


Medicine in short supply/unavailable:

  • CYKLOKAPRON 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
  • Import and supply approved until: 2 December 2020
    Section 19A approved medicine:

    Olmesartan medoxomil 40mg film coated tablets (Accord)


    Medicine in short supply/unavailable:

    • OLMESARTAN - MYL olmesartan medoxomil 40 mg tablet blister pack - ARTG 273572
    • OLMETEC olmesartan medoxomil 40 mg tablet blister pack - ARTG 102139

    Section 19A approval holder: Link Medical Products Pty Ltd ABN 730 109 715 16

    Approval holder phone number: 1800 181 060

    For the treatment of hypertension

    Import and supply approved until: 31 October 2020
    Section 19A approved medicine:

    NeoMercazole carbimazole 5mg tablets 100 bottle (Malaysia)


    Medicine in short supply/unavailable:

    • NEO-MERCAZOLE carbimazole 5mg tablet bottle - ARTG 194296

    Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd ABN 91 118 106 684

    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.

    Import and supply approved until: 30 September 2020
    Section 19A approved medicine:

    Carbimazole 5mg Tablets (AMDIPHARM UK)


    Medicine in short supply/unavailable:

    • NEO-MERCAZOLE carbimazole 5mg tablet bottle

    Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd ABN 91 118 106 684

    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.

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

    Epirubicin Accord epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (Austria)


    Medicine in short supply/unavailable:

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

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

    Approval holder phone number: 1800 222 673

    Epirubicin is used in the treatment of a range of neoplastic conditions including:

    • Carcinoma of the breast
    • Gastric cancer Intravesical administration
    • Treatment of papillary transitional cell carcinoma of the bladder
    • Treatment of carcinoma-in-situ of the bladder
    • Prophylaxis of recurrences after transurethral resection of superficial tumours

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

    PHENYTOIN SODIUM INJECTION USP 250mg/5mL solution for injection (Sterimax)


    Medicine in short supply/unavailable:

    • DBL PHENYTOIN INJECTION BP 250mg/5mL ampoule - ARTG 46943

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

    Approval holder phone number: 1800 181 060

    For the control of tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery.

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

    (Approval lapsed 18/08/2020) PHENYTOIN SODIUM INJECTION USP 100mg/2mL solution for injection (Sterimax)


    Medicine in short supply/unavailable:

    • DBL PHENYTOIN INJECTION BP 100mg/2mL ampoule - ARTG 46942

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

    Approval holder phone number: 1800 181 060

    For the control of tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery.

    Import and supply approved until: 1 November 2020
    Section 19A approved medicine:

    (Lapsed on 31 August 2020) DEXAFREE dexamethasone sodium phosphate 1 mg/ml eye drops solution in single-dose container


    Medicine in short supply/unavailable:

    • MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5% 5mg/mL eye drops ampoule - ARTG 32233

    Section 19A approval holder: HL Pharma Pty Ltd ABN 31 168 013 723

    Approval holder phone number: 03 9823 6228

    For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye.

    DEXAFREE dexamethasone sodium phosphate 1 mg/ml eye drops solution in single-dose container is not an extract substitute for of MINIMS PREDNISOLONE SODIUM PHOSPHATE (prednisolone) 0.5% 5mg/mL eye drops ampoule as they contain different active ingredients.
    Import and supply approved until: 31 July 2021
    Section 19A approved medicine:

    Isoproterenol Hydrochloride Injection, USP 1mg/5 mL solution for injection ampoule


    Medicine in short supply/unavailable:

    • Isuprel 1:5000 1mg/5mL injection - ARTG 198888

    Section 19A approval holder: Reach Pharmaceuticals Pty Ltd ABN 25 623 897 183

    Approval holder phone number: 0478 061 879

    For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.

    For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).

    For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available.

    For bronchospasm occurring during anesthesia.

    As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output

    (hypoperfusion) states, congestive heart failure, and cardiogenic shock.

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