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

Database of section 19A approvals to import and supply medicines during a shortage

27 February 2018

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.
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Section 19A approvals

Displaying 1 - 10 of 53

Enter a approval holder, product name, active ingredient, indication or ARTG number.

Section 19A approved medicine:

COTRIM-RATIOPHARM 480mg/5mL (sulfamethoxazole 400 mg/trimethoprim 80 mg) 5mL ampoules

Import and supply approved until: 31 October 2018

Medicine in short supply/unavailable:

  • DBL SULFAMETHOXAZOLE 400 mg AND TRIMETHOPRIM 80 mg CONCENTRATE INJECTION BP 5mL injection ampoule - ARTG 16293

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Parenteral administration of is indicated where oral dosage is not desirable or practical, e.g. pre- and post-operative infections associated with surgery, trauma or gynaecology; septicaemia and other infections due to sensitive organisms such as typhoid and paratyphoid.

Section 19A approved medicine:

ISOPRENALINE HYDROCHLORIDE MONICO 0.2mg/1mL solution for injection ampoule

Import and supply approved until: 15 August 2018

Medicine in short supply/unavailable:

  • ISUPREL 1:5000 isoprenaline hydrochloride 200 microgram/1mL injection ampoule - ARTG 198887

Section 19A approval holder:

Orpharma Pty Ltd ABN 19 157 901 267

Approval holder phone number: 03 9863 7501

  • Treatment of complete atrioventricular block (including Stokes-Adams syndrome) and cardiac arrest.

  • Treatment of bronchial spasm during anaesthesia.

  • In addition to treatment for cardiogenic shock.

  • Section 19A approved medicine:

    Heparin Sodium 10 I.U./mL flushing solution for maintenance of patency of intravenous devices (50 I.U. in 5mL)

    Import and supply approved until: 14 November 2018

    Medicine in short supply/unavailable:

    • HEPARINISED SALINE 50IU/5mL (porcine mucous) injection ampoule - ARTG 66684

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Maintenance of the patency of intravenous injection devices.

    Section 19A approved medicine:

    Bupivacaine Injection BP, bupivacaine hydrochloride 0.25% (50mg/20mL) single use vials

    Import and supply approved until: 15 April 2019

    Medicine in short supply/unavailable:

    • MARCAIN 0.25% bupivacaine hydrochloride (as monohydrate) 50mg/20mL injection ampoule - ARTG 48380

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Adults (> 18 years of age):

    BUPIVACAINE INJECTION BP (bupivacaine hydrochloride) is indicated for:

  • Local infiltration

  • Peripheral minor or major nerve blocks

  • Epidural block for surgery

  • Epidural block by continuous infusion or intermittent bolus for postoperative or labour pain relief

    Standard procedures for local infiltration, minor and major nerve blocks, retrobulbar block or epidural block should be observed.

    Geriatrics (> 65 years of age):

    Elderly patients should be given reduced doses commensurate with their age and physical condition.

    Pediatrics (< 2 years of age):

    Until further experience is gained in children younger than two years, administration of any presentation of bupivacaine injection in this age group is not recommended.

  • Section 19A approved medicine:

    VERSACLOZ (clozapine) 50 mg/mL oral suspension (Jazz Pharmaceuticals)

    Import and supply approved until: 30 April 2019

    Medicine in short supply/unavailable:

    • CLOPINE SUSPENSION clozapine 50 mg/mL oral liquid bottle - ARTG 142239

    Section 19A approval holder:

    Pfizer Australia Pty Ltd ABN 50 00 8422 348

    Approval holder phone number: 1800 675 229

    Treatment with VERSACLOZ is indicated only in people with treatment-resistant schizophrenia, ie. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.

    Section 19A approved medicine:

    Bupivacaine Injection BP, bupivacaine hydrochloride 0.5% (50mg/10mL) single use vials

    Import and supply approved until: 15 April 2019

    Medicine in short supply/unavailable:

    • MARCAIN 0.5% bupivacaine hydrochloride (as monohydrate) 50mg/10mL injection ampoule - ARTG 11937

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Adults (> 18 years of age):

    BUPIVACAINE INJECTION BP (bupivacaine hydrochloride) is indicated for:

  • Local infiltration

  • Peripheral minor or major nerve blocks

  • Epidural block for surgery

  • Epidural block by continuous infusion or intermittent bolus for postoperative or labour pain relief

    Standard procedures for local infiltration, minor and major nerve blocks, retrobulbar block or epidural block should be observed.

    Geriatrics (> 65 years of age):

    Elderly patients should be given reduced doses commensurate with their age and physical condition.

    Pediatrics (< 2 years of age):

    Until further experience is gained in children younger than two years, administration of any presentation of bupivacaine injection in this age group is not recommended.

  • Section 19A approved medicine:

    Bupivacaine Injection BP, bupivacaine hydrochloride 0.5% (100mg/20mL) single use vials

    Import and supply approved until: 15 April 2019

    Medicine in short supply/unavailable:

    • MARCAIN 0.5%w/v bupivacaine hydrochloride (as monohydrate) 100mg/20 mL injection ampoule - ARTG 48328

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Adults (> 18 years of age):

    BUPIVACAINE INJECTION BP (bupivacaine hydrochloride) is indicated for:

  • Local infiltration

  • Peripheral minor or major nerve blocks

  • Epidural block for surgery

  • Epidural block by continuous infusion or intermittent bolus for postoperative or labour pain relief

    Standard procedures for local infiltration, minor and major nerve blocks, retrobulbar block or epidural block should be observed.

    Geriatrics (> 65 years of age):

    Elderly patients should be given reduced doses commensurate with their age and physical condition.

    Pediatrics (< 2 years of age):

    Until further experience is gained in children younger than two years, administration of any presentation of bupivacaine injection in this age group is not recommended.

  • Section 19A approved medicine:

    PHENYLEPHRINE HYDROCHLORIDE Injection, USP 10 mg/mL, 1mL single dose vial

    Import and supply approved until: 31 October 2018

    Medicine in short supply/unavailable:

    • NEOSYNEPHRINE 1% phenylephrine hydrochloride 10mg/1mL injection USP ampoule - ARTG 15472

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

    Section 19A approved medicine:

    MAKRO-ALBUMON 2mg powder for suspension for injection, kit for radiopharmaceutical preparation 2mg Human Serum Albumin Macroaggregate

    Import and supply approved until: 31 May 2019

    Medicine in short supply/unavailable:

    • DRAXIMAGE MAA kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection - ARTG 261212
    • RADPHARM MAA kit for the production of Technetium (99mTc) Macrosalb powder for injection multidose vial - ARTG 54860

    Section 19A approval holder:

    Lantheus Medical Imaging Australia Pty Ltd ABN 61 505 899 757

    Approval holder phone number: 02 9503 8100

    Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients.

    Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.

    Section 19A approved medicine:

    PROMETHAZIN-NEURAXPHARM (promethazine hydrochloride) solution for injection 50mg/2mL ampoule

    Import and supply approved until: 31 July 2018

    Medicine in short supply/unavailable:

    • DBL PROMETHAZINE HYDROCHLORIDE 50mg/2mL injection BP ampoule - ARTG 16255

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Acute allergic reactions of the immediate type, if sedation is indicated at the same time.

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