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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 71 - 80 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 October 2023
Section 19A approved medicine:

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


Picture of Mebrofenin kit for the preparation of Technetium Tc 99m mebrofenin for injection (USA) - carton label

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 November 2021
Section 19A approved medicine:

(Approval lapsed) Tranexamic acid 500 mg film-coated tablets (Tillomed)


Picture of Tranexamic Acid 500mg tablets (TILLOMED) 60 tablets - carton label

Medicine in short supply/unavailable:

  • CYKLOKAPRON tranexamic acid 500mg tablet bottle - ARTG 14463

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: 1 May 2021
    Section 19A approved medicine:

    (Approval lapsed) Cisatracurium 2mg/ml (20mg/10ml) solution for injection/infusion (Noridem Enterprises)


    Picture of Cisatracurium 2mg/ml (20mg/10ml) solution for injection/infusion (Noridem Enterprises) - carton label
    Picture of Cisatracurium 2mg/ml (20mg/10ml) solution for injection/infusion (Noridem Enterprises) - vial label

    Medicine in short supply/unavailable:

    • NIMBEX cisatracurium (as besilate) 5mg/2.5mL injection ampoule - ARTG 55913
    • CISATRACURIUM JUNO 5 mg / 2.5 mL solution for injection ampoule - ARTG 226854 (MS-2020-NT-01127-1)
    • CISATRACURIUM JUNO 10 mg / 5mL solution for injection ampoule - ARTG 226857 (MS-2020-NT-01128-1)
    • CISATRACURIUM JUNO 150 mg /30 mL solution for injection vial - ARTG 226859 (MS-2020-NT-01129-1)
    • DBL CISATRACURIUM INJECTION CONCENTRATE cisatracurium (as besilate) 10 mg/5 mL solution for injection vial - ARTG 170580
    • DBL CISATRACURIUM INJECTION CONCENTRATE cisatracurium (as besilate) 5 mg/2.5 mL solution for injection vial - ARTG 170579

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

    Approval holder phone number: 03 8888 1288

    For use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

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

    Aspirin and Extended - release Dipyridamole Capsules 25mg/200mg (USA)


    Picture of Aspirin and Extended - release Dipyridamole Capsules 25mg/200mg (USA) - bottle label

    Medicine in short supply/unavailable:

    • DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle - ARTG 210808

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

    Approval holder phone number: 1300 788 261

    For the prevention of recurrent ischaemic stroke and transient ischaemic attacks

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

    (Approval lapsed) REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules


    Picture of REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules - carton image
    Picture of REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules - overlabel image

    Medicine in short supply/unavailable:

    • DBL GENTAMICIN 10mg/1mL (as sulfate) injection ampoule - ARTG 16339

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

    Approval holder phone number: 1800 181 060

    For the treatment of serious infections cause by susceptible strains of the following pathogens:

    Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus species (coagulase positive and coagulase negative).

    Gentamicin solution for injection may be used for the treatment of the following conditions when caused by susceptible organisms:

    • Septicaemia,
    • Respiratory tract infections,
    • Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis
    • Urinary tract infections (recurrent, complicated). Gentamicin injection is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials

    Gentamicin solution for injection may be considered as initial therapy in suspected or confirmed gram negative infections. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime. The decision to continue therapy with gentamicin should be based on the results of susceptibility tests, the severity of the infection, and the important additional considerations outlined in the SPECIAL WARNINGS AND PRECAUTIONS FOR USE section of the Australian PI. If the causative organisms are resistant to gentamicin and the patient is not responding favourably, other appropriate therapy should be instituted.

    REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules is supplied in a 2 mL ampoule which equates to a 5 mg/mL solution. This differs to the Australian registered product DBL GENTAMICIN INJECTION BP 10 mg/mL which is supplied as a 10 mg/mL solution.

    The packaging displays text in the German language. This product will have a secondary label attached, containing the translation of important information.

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

    (Approval lapsed) NECON 0.5/35 norethisterone 0.5mg and ethinylestradiol 35 microgram tablets (3 blister cards of 28 tablets) (Teva Pharmaceuticals USA, Inc).


    Image of NECON 0.5/35 norethisterone 0.5mg and ethinylestradiol 35 microgram tablets (3 blister cards of 28 tablets) (Teva Pharmaceuticals USA

    Medicine in short supply/unavailable:

    • NORIMIN 28 day tablet blister pack - ARTG 62133
    • BREVINOR 28 DAY tablet blister pack - ARTG 62132

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

    Approval holder phone number: 1300 788 261

    Contraception

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

    (Approval Lapsed) Fluoxetine 20mg capsules (Strides Pharma)


    Picture of Fluoxetine 20mg capsules (Strides Pharma) -carton image
    Picture of Fluoxetine 20mg capsules (Strides Pharma) -carton back image

    Medicine in short supply/unavailable:

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

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

    Approval holder phone number: 1800 181 060

    Depression: Fluoxetine is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required.

    Obsessive-compulsive disorder.

    Bulimia nervosa: Fluoxetine is indicated for the reduction of binge-eating and purging activity.

    Pre-menstrual Dysphoric Disorder (PMDD)

    Diagnosis of PMDD: The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective lability, accompanied by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) - all of which must be severe. This syndrome should be distinguished from the commoner 'pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)' and from any co-existing psychiatric disorder.

    Import and supply approved until: 30 September 2023
    Section 19A approved medicine:

    Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals)


    Picture of Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals) - bottle label
    Picture of Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals) - label

    Medicine in short supply/unavailable:

    • NARDIL phenelzine 15mg (as sulfate) tablet bottle - ARTG 93600

    Section 19A approval holder: Generic Health Pty Ltd ABN 93 110 617 859

    Approval holder phone number: 03 9809 7900

    For the treatment of depression. Phenelzine Sulfate Tablets should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.

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

    (Approval lapsed) Clopidogrel 75mg tablets, USP (USA)


    Picture of Clopidogrel 75mg tablets USP 30 tablet bottle label
    Picture of Clopidogrel 75mg tablets

    Medicine in short supply/unavailable:

    • PLAVIX clopidogrel (as hydrogen sulfate) 75 mg tablet blister pack - ARTG 78622
    • CLOPIDOGREL GH clopidogrel (as besilate) 75mg film-coated tablet - ARTG 164870

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

    Approval holder phone number: 1300 788 261

    Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with history of symptomatic atherosclerotic disease.

    Acute Coronary Syndrome

    Clopidogrel is indicated in combination with aspirin for patients with:

    • Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia)

  • Clopidogrel is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or PCI, with or without stent)
  • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy
  • Import and supply approved until: 31 March 2021
    Section 19A approved medicine:

    (Approval lapsed) Phenelzine Sulfate USP 15mg tablets (Lupin Pharmaceuticals) 60 tablet bottle


    Picture of Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals) - 60 tablet bottle label

    Medicine in short supply/unavailable:

    • NARDIL phenelzine 15mg (as sulfate) tablet bottle - ARTG 93600

    Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066

    For the treatment of depression. Phenelzine Sulfate Tablets should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.

    Contact sponsor via email: medinfo@barwonpharma.com.au

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