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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 1 - 10 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 June 2023
Section 19A approved medicine:

Curium Gallium (Ga-67) citrate 37 MBq/ml solution for injection (Curium Netherlands B.V.)


Medicine in short supply/unavailable:

  • LANTHEUS GALLIUM(67Ga) citrate 74MBq/mL injection USP multidose vial - ARTG 19144

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

Approval holder phone number: (02) 9503 8100

Gallium Citrate Ga 67 Injection, U.S.P. may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

Stock will not be available until the end of October 2022.

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

TRULICITY dulaglutide 1.5 mg/0.5 mL solution for injection prefilled pen (Netherlands)


Medicine in short supply/unavailable:

  • TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen - AUST R: 217965

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

Approval holder phone number: 1300 788 261

Type 2 Diabetes Mellitus - Trulicity 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 considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes

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

Thallous (TI201) Chloride Injection, 37MBq/mL, solution for injection (Curium)


Medicine in short supply/unavailable:

  • LANTHEUS THALLIUM[201Tl] CHLORIDE 74MBq/mL injection multidose vial AUST R: 112603

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

Approval holder phone number: (02) 9503 8100

Thallous Chloride Tl 201 Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction.

It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease.

Thallous Chloride Tl 201 Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyperparathyroidism

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

(Approval lapsed [31/07/2022]) Daunorubicin (Zentiva) 20mg powder for IV injection


Medicine in short supply/unavailable:

  • Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial

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

Approval holder phone number: 1800 181 060

  • Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.
  • Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g., cytarabine)

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

(Approval lapsed [31/07/2022]) QLAIRA estradiol valerate/dienogest film coated tablets composite pack in wallet pack (Jenapharm)


Medicine in short supply/unavailable:

  • QLAIRA estradiol valerate / dienogest tablets composite pack in wallet pack - ARTG 149319

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

Approval holder phone number: 1800 181 060

Oral contraception. Treatment of heavy menstrual bleeding without an organic cause in women who wish to use oral contraception.

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

(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled pen (Germany)


Medicine in short supply/unavailable:

  • ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector AUST R 236039

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

Approval holder phone number: 1300 788 261

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.

ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)

ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.

ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).

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

(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled syringe (Germany)


Medicine in short supply/unavailable:

  • ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange AUST R 206764

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

Approval holder phone number: 1800 181 060

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.

ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)

ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.

ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).

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

(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled pen (Germany)


Medicine in short supply/unavailable:

  • ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector AUST R 236039

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

Approval holder phone number: 1800 181 060

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.

ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)

ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.

ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).

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

Ethosuximide Essential Generics 250 mg Capsules (UK)


Medicine in short supply/unavailable:

  • ZARONTIN ethosuximide 250mg capsule bottle ARTG: 94175

Section 19A approval holder: Clinect Pty Ltd ABN 76 150 558 473

Approval holder phone number: 1800 899 005

For the control of petit mal epilepsy

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

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