You are here

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 11 - 20 of 354

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

Pyridostigmine bromide extended-release tablets 180mg (Rising Pharmaceuticals)


Medicine in short supply/unavailable:

  • MESTINON TIMESPAN pyridostigmine bromide 180mg tablet bottle AUST R: 13749

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

Approval holder phone number: 1300 788 261

Useful in the treatment of myasthenia gravis

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

TECHNELITE Technetium (Tc-99m) Generator


Picture of Technelite Technetium (Tc99m) generator - canister label

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: 30 June 2024
Section 19A approved medicine:

BCG Vaccine AJV - mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331 (AJ Vaccines) with Diluted Sauton AJV (New Zealand)


Medicine in short supply/unavailable:

  • BCG VACCINE Mycobacterium bovis (Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) (BCG) strain) 1.5mg powder for injection multidose vial with diluent vial - ARTG 53569

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

Approval holder phone number: 1800 181 060

BCG Vaccine AJV - mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331 (AJ Vaccines) with Diluted Sauton AJV (New Zealand) is recommended for active immunisation in high-risk groups and is to be used as per Australian national immunisation guidelines.

Import and supply approved until: 31 January 2023
Section 19A approved medicine:

TECHNESCAN MAG3 Kit for the Preparation of Technetium Tc 99m Mertiatide (USA)


Medicine in short supply/unavailable:

  • TECHNESCAN MAG3 Powder for injection - ARTG 10013

Section 19A approval holder: Landauer Radiopharmaceuticals Pty Ltd ABN: 90 606 510 776

Approval holder phone number: 02 8651 4009

Technetium Tc 99m Mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and paediatric patients.

It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

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

DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4mg/1mL (Mylan USA)


Medicine in short supply/unavailable:

  • DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4mg/1mL solution for injection vial AUST R: 163200

Section 19A approval holder: Alphapharm Pty Ltd ABN: 93 002 359 739

Approval holder phone number: 1800 274 276

Replacement Therapy: Adrenocortical insufficiency

Dexamethasone has predominantly glucocorticoid activity and, therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. When so supplemented, dexamethasone is indicated in the following:

  • Acute adrenocortical insufficiency - Addison's disease; bilateral adrenalectomy
  • Relative adrenocortical insufficiency Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should, therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns or severe infections where specific antibiotic therapy is available
  • Primary and secondary adrenocortical insufficiency
  • Disease Therapy - Dexamethasone is indicated for therapy of the following diseases:
    1. Collagen diseases. Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis -during an exacerbation or as maintenance therapy
    2. Pulmonary disorders. Status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency
    3. Blood disorders. Leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia
    4. Rheumatic diseases. Rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis
    5. Skin diseases. Psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis
    6. Gastrointestinal disorders. Ulcerative colitis, regional enteritis
    7. Oedema. Cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis)
    8. Eye disorders. Allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy
    9. Neoplastic states. Cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children
    10. Endocrine disorders. Adrenal insufficiency
  • Preoperative and postoperative support - Dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. This includes the treatment of shock due to excessive blood loss during surgery
  • Shock - Dexamethasone may be used as an adjunct in the treatment of shock
Import and supply approved until: 31 January 2024
Section 19A approved medicine:

TNKASE tenecteplase 50mg powder for solution kit (Canada)


Medicine in short supply/unavailable:

  • METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe - ARTG 75013

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN: 20605457430

Approval holder phone number: 1300 077 674

Indicated for the thrombolytic treatment of the acute phase of myocardial infarction.

Treatment should be initiated as soon as possible after the onset of symptoms.

Treatment can be initiated within 12 hours of symptom onset.

Import and supply approved until: 31 January 2024
Section 19A approved medicine:

TNKASE tenecteplase 50mg powder for solution kit (USA)


Medicine in short supply/unavailable:

  • METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe - ARTG 75013

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN: 20605457430

Approval holder phone number: 1300 077 674

Indicated for the thrombolytic treatment of the acute phase of myocardial infarction.

Treatment should be initiated as soon as possible after the onset of symptoms.

Treatment can be initiated within 12 hours of symptom onset.

Import and supply approved until: 30 September 2022
Section 19A approved medicine:

Ozempic 0.25mg/0.5mg solution for injection in pre-filled pen (USA)


Medicine in short supply/unavailable:

  • OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen AUST R: 308324

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN 20 6054 57430

Approval holder phone number: 1300 077 674

Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is not tolerated or contraindicated
  • in addition to other medicinal products for the treatment of type 2 diabetes
Import and supply approved until: 28 February 2023
Section 19A approved medicine:

Ultravist 370 iopromide 384.5g/500ml (equivalent to 370 mg/1 ml of organically bound iodine) solution for injection (India)


Medicine in short supply/unavailable:

  • ULTRAVIST 370 iopromide 38.443g/50mL injection bottle AUST R: 15681

Section 19A approval holder: Bayer Australia Ltd ABN 22 000 138 714

Approval holder phone number: 1800 008 757

ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography.

Import and supply approved until: 28 February 2023
Section 19A approved medicine:

Ultravist 370 iopromide 76.88g/100ml (equivalent to 370 mg/1 ml of organically bound iodine) solution for injection (Indonesia)


Medicine in short supply/unavailable:

  • ULTRAVIST 370 iopromide 38.443g/50mL injection bottle AUST R: 15681

Section 19A approval holder: Bayer Australia Ltd ABN 22 000 138 714

Approval holder phone number: 1800 008 757

ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography.

Pages