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

3 July 2020

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 184

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 December 2020
Section 19A approved medicine:

FRESENIUS PROPOVEN 1% propofol 1g/100mL emulsion for injection or infusion


Medicine in short supply/unavailable:

  • FRESOFOL 1% MCT/LCT propofol 500mg/50mL emulsion for intravenous injection/infusion vial - ARTG 193609

Section 19A approval holder: Fresenius Kabi Australia Pty Limited ABN 39 109 383 593

Approval holder phone number: 1300 732 001

FRESENIUS PROPOVEN 1% propofol 1g/100mL emulsion for injection or infusion is a short-acting intravenous general anaesthetic for:

  • induction of general anaesthesia in adults and children aged one month and older
  • maintenance of general anaesthesia in adults and children aged 3 years and older
  • maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided
  • sedation of ventilated adults receiving intensive care
  • Monitored conscious sedation in adults for surgical and diagnostic procedures
Import and supply approved until: 31 December 2020
Section 19A approved medicine:

Imipramine Hydrochloride Tablets, USP, 25mg 100 tablets (Leading Pharma, LLC)


Medicine in short supply/unavailable:

  • TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack - ARTG 60673

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

Approval holder phone number: 1300 077 674

  • Major depression
  • Nocturnal enuresis (from the age of 5 years onwards and provided the possibility of organic causes has first been excluded)

Import and supply approved until: 1 August 2021
Section 19A approved medicine:

Estradot 37.5 estradiol 37.5 microgram transdermal drug delivery system 8 pack


Medicine in short supply/unavailable:

  • ESTRADOT 37.5 estradiol 37.5 microgram transdermal drug delivery system sachet - ARTG 97562

Section 19A approval holder: Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

Short term oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.

Import and supply approved until: 30 November 2020
Section 19A approved medicine:

Metformin 500mg Prolonged Release Tablets (UK)


Medicine in short supply/unavailable:

  • DIABEX XR 500 metformin hydrochloride 500mg extended release tablet blister pack - ARTG 98982
  • APO-METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack - ARTG 281211
  • BLOOMS THE CHEMIST METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack - ARTG 278176
  • CHEMMART METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack - ARTG 197405
  • DIAFORMIN XR metformin hydrochloride 500mg extended release tablet blister pack - ARTG 120868
  • METEX XR metformin hydrochloride 500 mg modified release tablet blister pack - ARTG 232661
  • TERRY WHITE CHEMISTS METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack - ARTG 278180

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

Approval holder phone number: 1300 788 261

Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Metformin prolonged release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Import and supply approved until: 1 August 2021
Section 19A approved medicine:

Estradot 100 estradiol 100 microgram transdermal drug delivery system 8 pack


Medicine in short supply/unavailable:

  • ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system sachet - ARTG 97566

Section 19A approval holder: Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

Short term oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.

Import and supply approved until: 1 August 2021
Section 19A approved medicine:

Estradot 75 estradiol 75 microgram transdermal drug delivery system 8 pack


Medicine in short supply/unavailable:

  • ESTRADOT 75 estradiol 75 microgram transdermal drug delivery system sachet - ARTG 97565

Section 19A approval holder: Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

Short term oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.

Import and supply approved until: 1 August 2021
Section 19A approved medicine:

Estradot 50 estradiol 50 microgram transdermal drug delivery system 8 pack


Medicine in short supply/unavailable:

  • ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet - ARTG 97564

Section 19A approval holder: Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

Short term oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.

Import and supply approved until: 1 August 2021
Section 19A approved medicine:

Estradot 25 estradiol 25 microgram transdermal drug delivery system 8 pack


Medicine in short supply/unavailable:

  • ESTRADOT 25 estradiol 25 microgram transdermal drug delivery system sachet - ARTG 97562

Section 19A approval holder: Novartis Pharmaceuticals Australia Pty Ltd ABN 18 004 244 160

Approval holder phone number: 02 9805 3433

Short term oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. In women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.

Import and supply approved until: 30 April 2021
Section 19A approved medicine:

Tylenol paracetamol 500mg tablet 20 tablets


Medicine in short supply/unavailable:

  • Various Paracetamol Paediatric liquids are in shortage

Section 19A approval holder: Johnson & Johnson Pacific Pty Ltd ABN 73 001 121 446

Approval holder phone number: 1800 029 979

For effective temporary relief of pain and discomfort associated with colds, headaches, muscular pain, menstrual pain, and toothache. Also reduces fever.

TYLENOL paracetamol 500mg tablets are to be supplied via pharmacies. The blister platform paper backing for this product states acetaminophen 500 mg. Please be aware that paracetamol is known by actetominophen in some countries. A statement on the carton has been included.
Import and supply approved until: 31 July 2021
Section 19A approved medicine:

Co-Trimoxazole 16 mg/ 80 mg per ml for Infusion (5 mL ampoules)


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 Sulfamethoxazole 400 mg and Trimethoprim 80 mg Concentrate Injection 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.

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