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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

2 April 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 150

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

Section 19A approved medicine:

Adrenaline Aguettant (epinephrine) (as acid tartrate) solution for injection in pre-filled syringe (Ireland)

Medicine in short supply/unavailable:

  • ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe - ARTG 210672
  • ADRENALINE AGUETTANT 1:10,000 adrenaline (epinephrine) (as acid tartrate) 1 mg/10 mL solution for injection prefilled syringe - ARTG 282377

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

Approval holder phone number: 03 8888 1288

As an adjunct in the management of cardiac arrest

Import and supply approved until: 30 June 2021

Section 19A approved medicine:

Gentamicin 80mg/2mL injection

Medicine in short supply/unavailable:

  • DBL GENTAMICIN 80mg/2mL Injection BP - ARTG 47268

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

Approval holder phone number: 1800 181 060

For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics).

Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics.

Import and supply approved until: 30 June 2020

Section 19A approved medicine:

Sandoz K-8 Potassium Chloride 600mg Sustained Release tablets

Medicine in short supply/unavailable:

  • SPAN K potassium chloride 600mg tablet bottle - ARTG 27978

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

Approval holder phone number: 1800 181 060

Treatment of all types of potassium deficiencies, particularly hypochloraemic or hypokalaemic alkalosis associated with prolonged or intensive diuretic therapy, eg. in hypertension, cardiac failure or massive oedema (potassium replacement is particularly important to patients receiving digitalis, as the clinical response to this drug is seriously affected by hypokalaemia), in renal disease associated with increased potassium excretion eg. nephrotic syndrome; vomiting and diarrhoea, ulcerative colitis, steatorrhoea, diabetes insipidus, and uncontrolled diabetes mellitus; ileostomy or colostomy patients, cirrhosis; Cushing's syndrome and dietary insufficiency; during prolonged or intensive treatment with corticosteroids, ACTH or carbenoxolone; hyperaldosteronism in megaloblastic anaemia, during the early stages of treatment. If a diet rich in potassium cannot be guaranteed.

Import and supply approved until: 30 April 2020

Section 19A approved medicine:

Tranylcypromine tablets 10mg (Mercury Pharmaceuticals)

Medicine in short supply/unavailable:

  • PARNATE tranylcypromine (as sulphate) 10mg film coated tablet blister pack - ARTG 174086

Section 19A approval holder: Boucher & Muir Pty Ltd t/a Advanz Pharma ABN 58 000 140 474

Approval holder phone number: 02 9431 6333

Treatment of symptoms of depressive illness especially where treatment with other types of antidepressants has failed. It is not recommended for use in mild depressive states resulting from temporary situational difficulties.

Import and supply approved until: 30 September 2020

Section 19A approved medicine:

DRN 4366 Technescan HDP kit for radiopharmaceutical preparation 3.0mg/vial

Medicine in short supply/unavailable:

  • TECHNESCAN HDP kit for preparation of Technetium [99mTc] oxidronate powder for injection vial - ARTG 75500

Section 19A approval holder: Landauer Radiopharmaceuticals Pty Ltd ABN 90 606 510 776

Approval holder phone number: 02 8651 4000

Technescan HDP is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult patients

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: 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: 1300 788 261

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

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: 30 June 2020

Section 19A approved medicine:

Lidocaine 40mg/g (LMX 4) topical cream 5g tube and Lidocaine 40mg/g (LMX 4) topical cream 30g tube

Medicine in short supply/unavailable:

  • LMX 4 TOPICAL ANAESTHETIC CREAM lidocaine (lignocaine) 40 mg/g tubes with dressings - ARTG 208815

Section 19A approval holder: Dermocosmetica Pty Ltd ABN 52 152 881 019

Approval holder phone number: 03 9386 3503

LMX4 is indicated for topical anaesthesia of intact skin prior to superficial skin procedures

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.

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