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Database of section 19A approvals to import and supply medicines to address medicine shortages
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.
Standard conditions of approval
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.
Furosemid-ratiopharm (Furosemide) 500mg tablet
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
Furosemide (Frusemide) in a high-dosage formulation is intended exclusively for patients with severely impaired renal function. For use under strict medical supervision only within a hospital setting (see Dosage and Administration). High doses of frusemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, e.g. in the post-operative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the pre-dialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with the nephrotic syndrome with severe impairment of renal function e.g. in chronic glomerulonephritis, lupus erythematous and Kimmelstiel-Wilson syndrome. If diuresis is less than 2.5 L / day dialysis has to be used.
Additional information
Furosemid-ratiopharm 500mg Furosemide tablets, is registered and marketed in Germany by ratiopharm GmbH and therefore all labelling is in German. Pharmacists are instructed to direct consumers to disregard the patient leaflet contained within the pack and refer to the Australian Consumer Medicines Information available from: https://www.tga.gov.au .
Fluoxetine tablets USP 20mg (Dr Reddy's) 30 tablet bottle
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
Treatment of Major depression and Obsessive Compulsive Disorder.
NeoMercazole carbimazole 5mg tablets bottle of 50 (France)
Medicine in short supply/unavailable:
Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd
Approval holder phone number: 1800 627 680
Indications of the section 19A approved product
Therapy of hyperthyroidism. Definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. Preparation for thyroidectomy. Before and after radioactive iodine treatment.
Additional information
NeoMercazole carbimazole 5mg tablets bottle of 50 (France) is registered in France and the packaging and product leaflet contains text in the French language. Pharmacists are instructed to direct consumers to disregard the patient leaflet for NeoMercazole carbimazole 5mg tablets bottle of 50 (France) contained within the pack and refer to the Australian Consumer Medicines Information available from: https://www.tga.gov.au .
Tranylcypromine sulfate 10mg film coated tablets (Alvogen Inc)
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
Tranylcypromine sulfate is indicated for the 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.
Desmopressin Acetate Nasal Solution (Nasal Spray) 10mcg/0.1mL per spray 5mL bottle (Zydus Pharmaceuticals)
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
- Diabetes Insipidus - The treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria
Mebrofenin kit for the preparation of Technetium Tc 99m mebrofenin for injection (USA)
Medicine in short supply/unavailable:
Section 19A approval holder: Global Medical Solutions T/A Radpharm Scientific ABN 66 072 147 561
Approval holder phone number: 02 9503 8100
Indications of the section 19A approved product
Technetium Tc 99m Mebrofenin is indicated as an adjuct in the diagnosis of hepatobiliary disease.
Fluoxetine capsules USP 20mg (ScieGen) 100 capsule bottle
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
Treatment of Major depression and Obsessive Compulsive Disorder
TEVA-PRAZOSIN (Prazosin hydrochloride) 5mg tablets
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
In Patients with Hypertension.
Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.
Additional information
Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia
TEVA-PRAZOSIN (Prazosin hydrochloride) 2mg tablets
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
In Patients with Hypertension.
Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.
Additional information
Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia
TEVA-PRAZOSIN (Prazosin hydrochloride) 1mg tablets
Medicine in short supply/unavailable:
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
Indications of the section 19A approved product
In Patients with Hypertension.
Indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents.
Additional information
Please note overseas product is not approved for the treatment of congestive heart failure, Raynaud's Phenomenon, Raynaud's Disease or Benign Prostatic Hyperplasia