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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.
Carbimazole 5mg tablets (DAWA Ltd)
Medicine in short supply/unavailable:
Section 19A approval holder: Seed Pharma Pty Ltd ABN 81 612 154 373
Approval holder phone number: 1300 966 356
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.
TECHNELITE Technetium (Tc-99m) Generator
Medicine in short supply/unavailable:
Section 19A approval holder: Global Medical Solutions Australia Pty Limited ABN 66 072 147 561
Approval holder phone number: 02 9503 8100
Indications of the section 19A approved product
Technetium [99mTc] Generator is used for the preparation of Sodium Pertechnetate [99mTc] Injection.
Sodium Pertechnetate [99mTc] is used as an agent for:
- Brain Imaging,
- Thyroid Imaging,
- Salivary Gland Imaging and
- Blood Pool Imaging
EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (UK)
Medicine in short supply/unavailable:
Section 19A approval holder: Accord Healthcare Pty Ltd ABN 49 110 502 513
Approval holder phone number: 1800 222 673
Indications of the section 19A approved product
- Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases. Epirubicin Hydrochloride injection is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma and superficial bladder cancer (Tis, Ta)
Pethidine 100mg/2mL Solution for Injection, 2mL ampoule (Martindale)
Medicine in short supply/unavailable:
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516
Approval holder phone number: 1800 181 060
Indications of the section 19A approved product
Pethidine 50 mg/mL Solution for Injection ampoules (50 mg/mL & 100 mg/2 mL) are approved for use under Section 19A for the following indications:
- For short term (24 to 36 hours) management of severe pain
PARNATE Tranylcypromine tablets USP 10mg (GSK)
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.
Famotidine 40mg 28 tablet blister pack - Tillomed
Medicine in short supply/unavailable:
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 517
Approval holder phone number: 1800 181 060
Indications of the section 19A approved product
- 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
Famotidine 20mg 28 tablet blister pack - Tillomed
Medicine in short supply/unavailable:
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 517
Approval holder phone number: 1800 181 060
Indications of the section 19A approved product
- 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
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 .