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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.
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.
(Approval lapsed) Tranexamic acid 500 mg film-coated tablets (Tillomed)
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
- Hereditary angioneurotic oedema
(Approval lapsed) Cisatracurium 2mg/ml (20mg/10ml) solution for injection/infusion (Noridem Enterprises)
Medicine in short supply/unavailable:
Section 19A approval holder: Juno Pharmaceuticals Pty Ltd ABN 55 156 303 650
Approval holder phone number: 03 8888 1288
Indications of the section 19A approved product
For use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.
Aspirin and Extended - release Dipyridamole Capsules 25mg/200mg (USA)
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
For the prevention of recurrent ischaemic stroke and transient ischaemic attacks
(Approval lapsed) REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules
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
For the treatment of serious infections cause by susceptible strains of the following pathogens:
Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus species (coagulase positive and coagulase negative).
Gentamicin solution for injection may be used for the treatment of the following conditions when caused by susceptible organisms:
- Septicaemia,
- Respiratory tract infections,
- Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis
- Urinary tract infections (recurrent, complicated). Gentamicin injection is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials
Gentamicin solution for injection may be considered as initial therapy in suspected or confirmed gram negative infections. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime. The decision to continue therapy with gentamicin should be based on the results of susceptibility tests, the severity of the infection, and the important additional considerations outlined in the SPECIAL WARNINGS AND PRECAUTIONS FOR USE section of the Australian PI. If the causative organisms are resistant to gentamicin and the patient is not responding favourably, other appropriate therapy should be instituted.
Additional information
REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules is supplied in a 2 mL ampoule which equates to a 5 mg/mL solution. This differs to the Australian registered product DBL GENTAMICIN INJECTION BP 10 mg/mL which is supplied as a 10 mg/mL solution.
The packaging displays text in the German language. This product will have a secondary label attached, containing the translation of important information.
(Approval lapsed) NECON 0.5/35 norethisterone 0.5mg and ethinylestradiol 35 microgram tablets (3 blister cards of 28 tablets) (Teva Pharmaceuticals USA, 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
Contraception
(Approval Lapsed) Fluoxetine 20mg capsules (Strides Pharma)
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
Depression: Fluoxetine is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required.
Obsessive-compulsive disorder.
Bulimia nervosa: Fluoxetine is indicated for the reduction of binge-eating and purging activity.
Pre-menstrual Dysphoric Disorder (PMDD)
Diagnosis of PMDD: The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective lability, accompanied by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) - all of which must be severe. This syndrome should be distinguished from the commoner 'pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)' and from any co-existing psychiatric disorder.
Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals)
Medicine in short supply/unavailable:
Section 19A approval holder: Generic Health Pty Ltd ABN 93 110 617 859
Approval holder phone number: 03 9809 7900
Indications of the section 19A approved product
For the treatment of depression. Phenelzine Sulfate Tablets should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
(Approval lapsed) Clopidogrel 75mg tablets, USP (USA)
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
Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with history of symptomatic atherosclerotic disease.
Acute Coronary Syndrome
Clopidogrel is indicated in combination with aspirin for patients with:
- Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia)
(Approval lapsed) Phenelzine Sulfate USP 15mg tablets (Lupin Pharmaceuticals) 60 tablet bottle
Medicine in short supply/unavailable:
Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066
Indications of the section 19A approved product
For the treatment of depression. Phenelzine Sulfate Tablets should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
Additional information
Contact sponsor via email: medinfo@barwonpharma.com.au