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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

6 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 141

Enter an approval holder, product name, active ingredient, indication or ARTG number.
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: 31 July 2020

    Section 19A approved medicine:

    Dantrolene sodium 20mg injection vials

    Medicine in short supply/unavailable:

    • DANTRIUM dantrolene sodium hemiheptahydrate 20mg powder for injection vial - ARTG 14435

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

    Approval holder phone number: 1300 788 261

    DANTRIUM for injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis. It should be administered by intravenous injection as soon as the malignant hyperthermia reaction is recognised (i.e. tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilisation of anaesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

    Import and supply approved until: 29 February 2020

    Section 19A approved medicine:

    Phenoxymethylpenicillin (as potassium) 250mg tablets

    Medicine in short supply/unavailable:

    • CILICAINE VK 250mg capsule blister pack - ARTG 55676
    • ASPECILLIN VK phenoxymethylpenicillin 250mg (as potassium) tablet bottle - ARTG 200136
    • LPV phenoxymethylpenicillin 250mg (as potassium) capsule blister pack - ARTG 66511

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

    Approval holder phone number: 1300 788 261

    Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.

    Import and supply approved until: 29 February 2020

    Section 19A approved medicine:

    Phenoxymethylpenicillin (as potassium) 500mg tablets

    Medicine in short supply/unavailable:

    • CILICAINE VK phenoxymethylpenicillin (as potassium) 500mg capsules blister pack - ARTG 55675
    • ASPECILLIN VK phenoxymethylpenicillin 500mg (as potassium) tablets bottle - ARTG 200137
    • LPV phenoxymethylpenicllin 500mg (as potassium) capsule blister pack - ARTG 66511

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

    Approval holder phone number: 1300 788 261

    Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.

    Import and supply approved until: 31 March 2020

    Section 19A approved medicine:

    Cholestyramine-Jamp 4g powder for suspension

    Medicine in short supply/unavailable:

    • QUESTRAN LITE colestyramine 850mg/g powder sachet - ARTG 11971

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

    Approval holder phone number: 1300 788 261

    • Reduction of serum cholesterol levels and prevention of coronary heart disease. It is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low-density lipoproteins). It may be useful to lower elevated cholesterol that occurs in patients with combined hypercholesterolemia and hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.

    • Relief of pruritus associated with partial biliary obstruction. Patients with primary biliary cirrhosis may exhibit elevated serum cholesterol as part of their disease. When cholestyramine is used to treat the pruritus of partial biliary obstruction, it may lower serum cholesterol levels, produce no change, or cause rapid escape from a temporary lowering to pre-treatment levels or rebound.

      Relief of diarrhoea following ileal resection or ileal disease (cholerrhoeic enteropathy).

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