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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

7 November 2019

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 125

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

Section 19A approved medicine:

Nitrostat 0.3mg sublingual tablets (Canada)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • ANGININE glyceryl trinitrate 600microgram tablet bottle - ARTG 227783
  • LYCINATE glyceryl trinitrate 600microgram tablet bottle - ARTG 227784

Section 19A approval holder:

Pfizer Australia Pty Ltd ABN 50 00 8422 348

Approval holder phone number: 1800 675 229

NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Section 19A approved medicine:

Cyclizine Lactate 50 mg/ml solution for Injection (Pack of 5 x 1mL ampoules)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • VALOID cyclizine lactate 50 mg/1 mL injection ampoule - ARTG 180894

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

For the prevention of nausea and vomiting caused by narcotic analgesics and general anaesthetics in the post-operative period

Section 19A approved medicine:

Tranylcypromine tablets 10mg (Mercury Pharmaceuticals)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

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

Section 19A approval holder:

Boucher and Muir Pty Ltd trading as BNM Group 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.

Section 19A approved medicine:

KamRAB 150 IU/ml Solution for Injection (Human Rabies immunoglobulin)

Import and supply approved until: 31 January 2021

Medicine in short supply/unavailable:

  • IMOGAM RABIES PASTEURIZED human rabies immunoglobulin 150 IU/mL injection vial - ARTG 72931

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 517

Approval holder phone number: 1800 181 060

KamRAB 150 IU/mL Solution for injection - 2mL vial (Human Rabies immunoglobulin) in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine.

Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated).

Section 19A approved medicine:

Gentech molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate (99mTc) injection multidose vial

Import and supply approved until: 15 February 2020

Medicine in short supply/unavailable:

  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate (99mTc) injection multidose vial - ARTG 72820
  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate (99mTc) 370GBq injection multidose vial - ARTG 75859

Section 19A approval holder:

Australian Nuclear Science and Technology Organisation T/A ANSTO ABN 47 956 969 590

Approval holder phone number: 1800 251 572

Sodium pertechnetate [99mTc] is used for scintigraphy, principally of the brain and thyroid. It can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.

Section 19A approved medicine:

Rizatriptan 10mg Orodisperible Tablets (Actavis)

Import and supply approved until: 15 January 2020

Medicine in short supply/unavailable:

  • MAXALT rizatriptan (as benzoate) 10mg wafer blister pack - ARTG 69076

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 517

Approval holder phone number: 1800 181 060

For the acute treatment of migraine attacks with or without aura

Section 19A approved medicine:

Leucovorin Calcium for Injection 100mg Powder for solution

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • Pfizer (Perth) LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 100mg/10mL injection USP ampoule - ARTG 61887

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

Section 19A approved medicine:

Gentamicin Injection USP 80mg/2mL solution for injection - 10 ampoules

Import and supply approved until: 29 February 2020

Medicine in short supply/unavailable:

  • GENTAMICIN INJECTION B.P. 80mg/2mL - ARTG 11376

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 517

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.

In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk of toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

GENTAMICIN INJECTION USP 80mg/2mL solution for injection contains preservative therefore it may cause airway irritation if administered via inhalation. A safety advisory regarding this issue is available at https://www.tga.gov.au/alert/gentamicin-injection-...

Section 19A approved medicine:

Heparin sodium 5000IU/0.2mL Solution for injection or concentrate for solution for infusion - ten ampoules (Wockhardt UK Ltd)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2mL injection BP ampoule - ARTG 16349

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Heparin is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism. Heparin is indicated for the treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. It is also used in haemodialysis and other extracorporeal circulation

Section 19A approved medicine:

Verorab (Rabies vaccine) powder and solvent for suspension for injection in prefilled syringe

Import and supply approved until: 31 August 2020

Medicine in short supply/unavailable:

  • RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent pre-filled syringe - ARTG 298194
  • MERIEUX INACTIVATED RABIES VACCINE 2.5IU powder for injection vial with diluent syringe - ARTG 26675

Section 19A approval holder:

Sanofi-Aventis Australia Pty Ltd ABN 31 008 558 807

Approval holder phone number: 1800 818 806

VERORAB is indicated for pre-exposure immunisation in persons at special risk of contracting rabies as well as post exposure immunisation against rabies.

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