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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

20 February 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 144

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 October 2020

Section 19A approved medicine:

Lidocaine /Prilocaine 25mg/g periodontal gel (USA)

Medicine in short supply/unavailable:

  • ORAQIX Periodontal Gel lidocaine (lignocaine) 25 mg/g and prilocaine 25 mg/g - ARTG 143855

Section 19A approval holder: Dentsply Sirona Pty Ltd ABN: 8711 1950 602

Approval holder phone number: 1300 552 929

Lidocaine /Prilocaine 25mg/g periodontal gel (USA) is indicated in adults for localised anaesthesia in periodontal pockets for probing, scaling and/or root planning

Import and supply approved until: 31 January 2021

Section 19A approved medicine:

Pethidine Hydrochloride 100mg/2mL solution for injection (Amino AG)

Medicine in short supply/unavailable:

  • DBL PETHIDINE HYDROCHLORIDE 100mg/2mL injection BP ampoule - ARTG 107387
  • ASTRAZENECA PETHIDINE pethidine hydrochloride 100mg/2mL injection BP ampoule - ARTG 48345

Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 893

Approval holder phone number: 1301 788 261

Pethidine is indicated for short term (24 to 36 hours) relief of severe pain

Import and supply approved until: 31 January 2021

Section 19A approved medicine:

Pethidine Hydrochloride 50mg/mL solution for injection (Amino AG)

Medicine in short supply/unavailable:

  • DBL PETHIDINE HYDROCHLORIDE 50mg/1mL injection BP ampoule - ARTG 107386

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

Approval holder phone number: 1300 788 261

Pethidine is indicated for short term (24 to 36 hours) relief of severe pain

Import and supply approved until: 30 April 2020

Section 19A approved medicine:

Famotidine 40mg tablets

Medicine in short supply/unavailable:

  • AUSFAM 40 Famotidine 40mg tablet blister pack - ARTG 93789

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

Approval holder phone number: 1800 181 060

Duodenal ulcer; benign gastric ulcer, Zollinger-Ellison syndrome, prevention of relapses of duodenal ulceration, short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures, healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease, prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease.

Import and supply approved until: 30 April 2020

Section 19A approved medicine:

Famotidine 20mg tablets

Medicine in short supply/unavailable:

  • AUSFAM 20 famotidine 20mg tablet blister pack - ARTG 93788

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

Approval holder phone number: 1800 181 060

Duodenal ulcer; benign gastric ulcer, Zollinger-Ellison syndrome, prevention of relapses of duodenal ulceration, short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures, healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease, prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease.

Import and supply approved until: 15 September 2020

Section 19A approved medicine:

Suxamethonium Chloride 50mg/ml Solution for injection 10 Ampoules

Medicine in short supply/unavailable:

  • ASTRAZENECA SUXAMETHONIUM CHLORIDE 100 mg/2 mL Solution for injection - ARTG 11988

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

Approval holder phone number: 03 8888 1288

For the production of skeletal muscle relaxation in anaesthesia. Suited for procedures requiring only brief relaxation such as endotracheal intubation, endoscopic examinations, orthopaedic manipulations, short surgical procedures and electro-convulsive therapy.

Import and supply approved until: 30 September 2020

Section 19A approved medicine:

Salbutamol 5mg/2.5mL Nebuliser solution (Breath Limited)

Medicine in short supply/unavailable:

  • VENTOLIN NEBULES salbutamol 5mg/2.5mL (as sulfate) inhalation solution ampoule - ARTG 12534

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

Approval holder phone number: 1800 181 060

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease.

Import and supply approved until: 30 September 2020

Section 19A approved medicine:

Salbutamol 2.5mg/2.5mL Nebuliser solution (Breath Limited)

Medicine in short supply/unavailable:

  • VENTOLIN NEBULES salbutamol 2.5mg/2.5mL (as sulfate) inhalation solution ampoule - ARTG 12533

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

Approval holder phone number: 1800 181 060

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease.

Import and supply approved until: 31 March 2020

Section 19A approved medicine:

Famciclovir 250mg tablets, bottle of 30

Medicine in short supply/unavailable:

  • FAVIC 250 famciclovir 250 mg tablets blister pack - ARTG 159611
  • FAMCICLOVIR GENERICHEALTH famciclovir 250 mg tablet blister pack - ARTG 177012
  • EZOVIR famciclovir 250 mg tablet blister pack - ARTG 157788
  • FAMCICLOVIR SANDOZ famciclovir 250mg tablet blister pack - ARTG 162313
  • FAMVIR famciclovir 250mg tablet blister pack - ARTG 51389
  • APO-FAMCICLOVIR famciclovir 250mg tablet blister pack - ARTG 160556

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

Approval holder phone number: 1300 788 261

The treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.

Suppression of recurrent genital herpes.

The treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.

It is indicated in immunocompromised patients for treatment of recurrent herpes simplex.

Import and supply approved until: 30 April 2020

Section 19A approved medicine:

Levodopa/Carbidopa 50mg/200mg Prolonged-Release tablets

Medicine in short supply/unavailable:

  • SINEMET CR levodopa/carbidopa 200 mg/50 mg modified release tablet bottle - ARTG 171694

Section 19A approval holder: Merck Sharp & Dohme (MSD)

Approval holder phone number: 1800 818 553

Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited in patients who have not been treated with levodopa before.

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