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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

8 January 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 135

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

Section 19A approved medicine:

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

Import and supply approved until: 31 August 2020

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.

Section 19A approved medicine:

Phenoxymethylpenicillin (as potassium) 250mg tablets

Import and supply approved until: 29 February 2020

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.

Section 19A approved medicine:

Phenoxymethylpenicillin (as potassium) 500mg tablets

Import and supply approved until: 29 February 2020

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.

Section 19A approved medicine:

Cholestyramine-Jamp 4g powder for suspension

Import and supply approved until: 31 March 2020

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).

Section 19A approved medicine:

Dantrolene sodium 20mg injection vials

Import and supply approved until: 31 July 2020

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).

Section 19A approved medicine:

Tamoxifen citrate 20mg tablets (Wockhardt)

Import and supply approved until: 31 July 2020

Medicine in short supply/unavailable:

  • GENRX TAMOXIFEN tamoxifen 20mg (as citrate) tablet bottle - ARTG 153122
  • TAMOSIN tamoxifen 20mg (as citrate) tablet - ARTG 43527
  • TAMOXIFEN SANDOZ tamoxifen 20mg (as citrate) tablet blister pack - ARTG 80076
  • GENOX 20 tamoxifen 20mg (as citrate) tablet blister pack - ARTG 40065
  • NOLVADEX-D Tamoxifen 20mg (as citrate) tablet blister pack - ARTG 11232

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 517

Approval holder phone number: 1800 181 060

Tamoxifen citrate 20mg tablets (Wockhardt) is indicated for the treatment of breast cancer and the primary prevention of breast cancer in women at moderate or high risk

Section 19A approved medicine:

NIFEdipine Extended-Release Tablets 60mg

Import and supply approved until: 1 July 2020

Medicine in short supply/unavailable:

  • ADEFIN XL 60 nifedipine 60mg modified release tablet blister pack - ARTG 91778
  • ADALAT OROS 60 nifedipine 60mg modified release tablet blister pack - ARTG 76040
  • ADDOS XR 60 nifedipine 60mg controlled release tablet blister pack - ARTG 98806
  • APO-NIFEDIPINE XR nifedipine 60mg controlled release tablet blister pack - ARTG 152208

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

  • The treatment of mild to moderate hypertension

  • The prophylaxis of chronic stable angina pectoris
  • Section 19A approved medicine:

    NIFEdipine Extended-Release Tablets 30mg

    Import and supply approved until: 1 July 2020

    Medicine in short supply/unavailable:

    • ADEFIN XL 30 nifedipine 30mg modified release tablet blister pack - ARTG 91779
    • ADALAT OROS 30 nifedipine 30mg modified release tablet blister pack - ARTG 76041
    • APO-NIFEDIPINE XR nifedipine 30mg controlled release tablet blister pack - ARTG 152207
    • ADDOS XR 30 nifedipine 30mg controlled release tablet blister pack - ARTG 114825

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

  • The treatment of mild to moderate hypertension

  • The prophylaxis of chronic stable angina pectoris
  • Section 19A approved medicine:

    Intuniv 1mg Extended Release tablets

    Import and supply approved until: 31 March 2020

    Medicine in short supply/unavailable:

    • Intuniv (guanfacine hydrochloride) 1mg - ARTG 275278

    Section 19A approval holder:

    Shire Australia Pty Ltd

    Approval holder phone number: 02 8019 4400

    INTUNIV is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants). INTUNIV must be used as part of a comprehensive ADHD management programme, typically including psychological, educational and social measures.

    Section 19A approved medicine:

    Apo-Pindolol 5mg tablets (Canada)

    Import and supply approved until: 1 February 2020

    Medicine in short supply/unavailable:

    • BARBLOC 5 pindolol 5mg tablet bottle - ARTG 755877

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

  • Management of hypertension (either alone or in combination with other anti-hypertensive drugs)

  • Management of angina pectoris (prevention of attacks).

  • Management of cardiac arrhythmias [sinus tachycardia, paroxysmal tachycardia, supraventricular and ventricular extrasystoles, drug induced extrasystoles (digitalis), atrial flutter and fibrillation - to slow the ventricular rate].

  • Functional hyperadrenergic cardiac disturbances (hyperkinetic heart syndrome, neurocirculatory asthenia).
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