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

20 May 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 10

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 January 2023
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

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 162mg/0.9mL solution for injection in pre-filled pen (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 162mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector AUSTR: 296808

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

Approval holder phone number: 1300 077 674

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) 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: Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

Approval holder phone number: 1300 077 674

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 200mg/10mL concentrate for solution for infusion (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial - AUST R: 149404

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

Approval holder phone number: 1300 077 674

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 400mg/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: Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

Approval holder phone number: 1300 077 674

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 162mg/0.9mL solution for injection in pre-filled syringe (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 162mg/0.9 mL solution for Injection pre-filled syringe - AUSTR: 234034

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

Approval holder phone number: 1300 788 261

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 January 2023
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

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 162mg/0.9mL solution for injection in pre-filled pen (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 162mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector AUSTR: 296808

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

Approval holder phone number: 1300 788 261

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 January 2023
Section 19A approved medicine:

RoActemra tocilizumab 200 mg/ 10mL concentrate for solution for infusion (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial - AUST R 149404

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

Approval holder phone number: 1300 788 261

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: 28 February 2022
Section 19A approved medicine:

(Approval lapsed) RoActemra tocilizumab 162mg/0.9mL solution for injection in pre-filled syringe (Roche Germany)


Medicine in short supply/unavailable:

  • ACTEMRA tocilizumab (rch) 162mg/0.9 mL solution for Injection pre-filled syringe - AUSTR: 234034

Section 19A approval holder: Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

Approval holder phone number: 1300 077 674

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.