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

21 September 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.

Standard conditions of approval

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.

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Section 19A approvals

Displaying 1 - 10 of 265

Import and supply approved until: 28 February 2022

Section 19A approved medicine: RoActemra tocilizumab 80mg/4mL concentrate for solution for infusion (Roche Germany)

Medicine in short supply/unavailable:

ACTEMRA tocilizumab (rch) 80 mg/4 mL injection concentrated vial - AUST R 149403

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Rheumatoid Arthritis:

Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.

Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.

In the two groups of patients above, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tocilizumab has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis:

Tocilizumab is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). It can be given alone or in combination with MTX.

Systemic Juvenile Idiopathic Arthritis:

Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Cytokine Release Syndrome (CRS):

Tocilizumab is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

Import and supply approved until: 30 November 2021

Section 19A approved medicine: DUPIXENT dupilumab 200mg/1.14mL solution for injection in pre-filled syringe with needle shield (USA)

Medicine in short supply/unavailable:

DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled syringe with needle shield - AUST R 302463

Section 19A approval holder: Sanofi - Aventis Australia Pty Ltd ABN 31 008 558 807

Approval holder phone number: 1800 818 806

Indications of the section 19A approved product

Dupixent is indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.

Dupixent is indicated as add on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO).

Dupixent is indicated as maintenance therapy for oral corticosteroid dependent asthma.

Import and supply approved until: 30 November 2021

Section 19A approved medicine: Dosulepin capsules 25 mg (Strides Pharma UK Ltd)

Medicine in short supply/unavailable:

DOSULEPIN MYLAN 25 dosulepin (dothiepin) hydrochloride 25 mg hard capsule blister pack - AUST R: 289783
DOTHEP 25 dosulepin (dothiepin) hydrochloride 25mg capsule blister pack - AUST R 34419

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

For the treatment of major depression.

Import and supply approved until: 31 October 2021

Section 19A approved medicine: CHARCODOTE activated charcoal 50g/250mL oral suspension bottle (Teva UK)

Medicine in short supply/unavailable:

CARBOSORB X activated charcoal 50 g/250 mL suspension bottle - AUST R 106470

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

For the treatment of poisoning and drug overdosage by oral ingestion.

Import and supply approved until: 30 September 2021

Section 19A approved medicine: Pyridostigmine bromide 60mg tablets, USP (Zydus)

Medicine in short supply/unavailable:

MESTINON pyridostigmine bromide 60mg tablet bottle - AUST R 13748

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Mestinon is useful in the treatment of myasthenia gravis.

Import and supply approved until: 30 November 2021

Section 19A approved medicine: Nitrofurantoin 50mg capsules, USP (Macrocrystals) (Sun Pharma)

Medicine in short supply/unavailable:

APO-NITROFURANTOIN nitrofurantoin 50 mg capsule bottle pack - AUST R 299383

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens

Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis

Import and supply approved until: 30 September 2021

Section 19A approved medicine: Nitrofurantoin 100mg Capsules (Morningside Healthcare)

Medicine in short supply/unavailable:

APO-NITROFURANTOIN nitrofurantoin capsule 100 mg capsule bottle pack - ARTG 299385

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens

Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis

Import and supply approved until: 28 February 2022

Section 19A approved medicine: RoActemra tocilizumab 400 mg/ 20mL concentrate for solution for infusion (Roche Germany)

Medicine in short supply/unavailable:

ACTEMRA tocilizumab (rch) 400 mg/20 mL injection concentrated vial - AUST R 149402

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

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product