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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

5 September 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 112

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

Section 19A approved medicine:

Tranylcypromine 10mg tablets (Concordia Pharmaceuticals)

Import and supply approved until: 1 December 2019

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:

Mianserin 10mg film-coated tablets (UK)

Import and supply approved until: 29 February 2020

Medicine in short supply/unavailable:

  • LUMIN 10 Mianserin hydrochloride 10mg tablet blister pack - ARTG 55272

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

For the treatment of major depression

Section 19A approved medicine:

Benzylpenicillin sodium 1200mg Powder for Injection (Genus Pharmaceuticals)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • BENPEN benzylpenicillin (as sodium) 1.2g powder for injection vial - ARTG 10326

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Treatment of infections caused by benzylpenicillin sensitive organisms. These include Streptococcus pyogenes and most other Gram-positive organisms. It is also indicated for the treatment of syphilis. BENPEN may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where Streptococci are the likely pathogens.

Section 19A approved medicine:

Benzylpenicillin sodium 600mg Powder for Injection (Genus Pharmaceuticals)

Import and supply approved until: 13 February 2020

Medicine in short supply/unavailable:

  • BENPEN benzylpenicillin (as sodium) 600mg powder for injection vial - ARTG 10329

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Treatment of infections caused by benzylpenicillin sensitive organisms. These include Streptococcus pyogenes and most other Gram-positive organisms. It is also indicated for the treatment of syphilis. BENPEN may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where Streptococci are the likely pathogens.

Section 19A approved medicine:

Tranylcypromine sulfate 10mg film coated tablets (Alvogen Inc)

Import and supply approved until: 1 December 2019

Medicine in short supply/unavailable:

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

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

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

Section 19A approved medicine:

Heparin sodium 5000 IU/mL solution for injection or concentrate for solution for infusion (UK)

Import and supply approved until: 10 October 2019

Medicine in short supply/unavailable:

  • DBL HEPARIN SODIUM 5000IU/1mL (porcine mucous) injection BP ampoule - ARTG 12881

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:

Pethidine 100mg/2mL Solution for Injection, 2mL ampoule

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • DBL PETHIDINE HYDROCHLORIDE 100mg/2mL injection BP ampoule - ARTG 107387

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

  • For short term (24 to 36 hours) relief of moderate to severe pain.

  • For administration as an anaesthetic adjunct and for obstetric analgesia.

    Approved routes of administration: Intramuscular, intravenous or subcutaneous injection.

  • Section 19A approved medicine:

    Leucovorin calcium injection 100mg/10mL lyophilized 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

    Leucovorin Calcium Injection is indicated 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:

    M-M-R VaxPro Measles virus, Mumps virus, Rubella virus 0.5mL Powder and Solvent for Injection Suspension

    Import and supply approved until: 1 November 2019

    Medicine in short supply/unavailable:

    • PRIORIX ALBUMIN FREE VACCINE 0.5mL powder for injection vial and diluent syringe - ARTG 97842
    • M-M-R II powder for injection vial with pre-filled diluent syringe, single dose - ARTG 201877

    Section 19A approval holder:

    HL Pharma Pty Ltd ABN 31 168 013 723

    Approval holder phone number: 03 9823 6228

    Active immunisation against measles, mumps and rubella from 12 months of age

    Section 19A approved medicine:

    Calcium Folinate 300mg/30mL Solution for Injection (Teva)

    Import and supply approved until: 31 January 2020

    Medicine in short supply/unavailable:

    • DBL LEUCOVORIN CALCIUM Folinic acid 300mg/30mL (as calcium folinate) Injection Vial - ARTG 116688

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Reducing the toxicity and circumventing the effect of folic acid antagonists, if therapeutically desired

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