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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 331 - 340 of 354

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

AGUETTANT SODIUM VALPORATE 400mg/4mL, solution for injection


Picture of  AGUETTANT SODIUM VALPORATE  400mg/4mL

Medicine in short supply/unavailable:

  • SODIUM VALPROATE JUNO sodium valproate 400 mg/4mL solution for injection, ampoule AUST R: 281241
  • SODIUM VALPROATE WOCKHARDT sodium valproate 400 mg/4 mL solution for injection ampoule AUST R: 279248

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

Approval holder phone number: 03 8888 1288

Sodium valproate is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

(Approval lapsed) Primidone Tablets USP 250mg (Lannett)


Picture of Primidone Tablets USP 250mg (Lannett)

Medicine in short supply/unavailable:

  • MYSOLINE primidone 250mg tablet bottle - AUST R 11231

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

Approval holder phone number: 1800 181 060

The management of grand mal and psychomotor (temporal lobe) epilepsy. It is also of value in the management of focal or Jacksonian seizures, myoclonic jerks and akinetic attacks.

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

Thiotepa for Injection, USP 15mg/vial (Novadoz)


Picture of Thiotepa for Injection
Picture of Thiotepa for Injection

Medicine in short supply/unavailable:

Section 19A approval holder: Reach Pharmaceuticals Pty Ltd ABN 25 623 897 183

Approval holder phone number: 0478 061 879

As conditioning treatment prior to haematopoietic progenitor cell transplantation

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

Gemfibrozil tablets, USP 600mg (Cipla)


Picture of Gemfibrozil tablets

Medicine in short supply/unavailable:

  • LIPIGEM gemfibrozil 600mg tablet bottle AUST R 61430

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

Approval holder phone number: 1300 077 674

Gemfibrozil is indicated as an adjunct to diet and other therapeutic measures for:

  • Severe hypertriglyceridaemia (Type IV and V) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them

  • Dyslipidaemia associated with diabetes
  • Reduction of risk of coronary heart disease in patients with Type IIa and IIb hypercholesterolaemia
  • Import and supply approved until: 31 July 2022
    Section 19A approved medicine:

    Sublocade (buprenorphine extended-release) 300 mg/1.5 mL Injection (USA)


    Picture of Sublocade (buprenorphine extended-release) 300 mg/1.5 mL Injection (USA) - carton

    Medicine in short supply/unavailable:

    • SUBLOCADE (buprenorphine modified-release) 300 mg/1.5 mL Injection AUST R 303753

    Section 19A approval holder: Indivior Pty Ltd ABN 22 169 280 102

    Approval holder phone number: 02 9025 0200

    SUBLOCADE is indicated for maintenance treatment of opioid dependence, within a framework of medical, social and psychological treatment.

    Import and supply approved until: 7 July 2021
    Section 19A approved medicine:

    (Approval lapsed) INHIXA enoxaparin 20mg/0.2mL solution for injection pre-filled syringe with needle guard (UK)


    Picture of INHIXA enoxaparin 20mg/0.2mL solution for injection pre-filled syringe with needle guard (UK) - carton label

    Medicine in short supply/unavailable:

    • CLEXANE enoxaparin sodium 20mg/0.2mL injection syringe with safety lock system - ARTG 221717

    Section 19A approval holder: Orspec Pharma Pty Ltd ABN 15 634 980 417

    Approval holder phone number: 02 43394239

    • Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery

  • Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness
  • Prevention of thrombosis in extra-corporeal circulation during haemodialysis
  • Treatment of established deep vein thrombosis
  • Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin
  • Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)
  • Import and supply approved until: 30 April 2022
    Section 19A approved medicine:

    (Approval lapsed) Dutasteride 0.5mg capsules (Camber Pharmaceuticals)


    Picture of Dutasteride 0.5mg capsules (Camber Pharmaceuticals)

    Medicine in short supply/unavailable:

    • APO-Dutasteride dutasteride 500 microgram soft capsule blister pack - AUST R: 212047

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

    Approval holder phone number: 1800 181 060

    Dutasteride is indicated for use as monotherapy for the management of symptomatic benign prostatic hyperplasia (BPH) or as combination therapy with an alpha blocker which is approved for use in BPH and which has been dose titrated in accordance with the relevant recommendations in the product information for that alpha blocker.

    Import and supply approved until: 28 February 2022
    Section 19A approved medicine:

    (Approval lapsed) Atenolol Oral Solution 25mg/5mL (Cresent)


    Picture of Atenolol Oral Solution 25mg/5mL (Cresent) - carton label

    Medicine in short supply/unavailable:

    • Atenolol-AFT atenolol 50 mg/10 mL oral solution bottle- ARTG 184745

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

    Approval holder phone number: 1300 788 261

    • All grades of hypertension, including hypertension of renal origin

  • Frequent disabling angina without evidence of cardiac failure
  • Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction)
  • Myocardial infarction - Late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain)
  • Import and supply approved until: 31 March 2022
    Section 19A approved medicine:

    (Approval lapsed) Cisatracurium - hameln 2mg/mL solution for injection/infusion 5mg/2.5mL ampoules (Germany)


    Picture of Cisatracurium - hameln 2mg/mL solution for injection/infusion 5mg/2.5mL ampoules (Germany)

    Medicine in short supply/unavailable:

    • CISATRACURIUM JUNO Cisatracurium besilate 5mg/2.5mL Solution for Injection ampoule - AUSTR 226854
    • CISATRACURIUM JUNO cisatracurium (as besilate) 10mg/5mL Solution for Injection ampoule - AUSTR 226857

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

    Approval holder phone number: 1800 181 060

    Cisatracurium is indicated 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 August 2022
    Section 19A approved medicine:

    Cisatracurium 10mg/5mL (2mg/mL) solution for injection/infusion 5mL ampoules (Kalcex)


    Picture of Cisatracurium 10mg/5mL (2mg/mL) solution for injection/infusion 5mL ampoules (Kalcex)

    Medicine in short supply/unavailable:

    • CISATRACURIUM JUNO Cisatracurium besilate 5mg/2.5mL Solution for Injection ampoule - AUSTR 226854 - anticipated
    • CISATRACURIUM JUNO cisatracurium (as besilate) 10mg/5mL Solution for Injection ampoule - AUSTR 226857 - anticipated

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

    Approval holder phone number: 03 8888 1288

    Cisatracurium is indicated 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 naesthesia, or sedation in the intensive care unit.

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