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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

16 August 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 105

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

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:

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:

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

Section 19A approved medicine:

MIOCHOL-E acetylcholine chloride 20mg in 2mL powder for solution

Import and supply approved until: 30 November 2019

Medicine in short supply/unavailable:

  • MIOCHOL-E acetylcholine chloride 20mg/2mL powder for solution for intraocular irrigation ampoule - ARTG 118510

Section 19A approval holder:

Bausch & Lomb Australia Pty Ltd ABN 88 000 222 408

Approval holder phone number: 1800 251 150

To obtain complete miosis of the iris in seconds after placement of the intraocular lens (IOL) in cataract surgery and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.

Section 19A approved medicine:

NARDIL Phenelzine Sulfate Tablets USP 15mg

Import and supply approved until: 31 October 2019

Medicine in short supply/unavailable:

  • NARDIL phenelzine 15mg (as sulfate) tablet bottle - ARTG 93600

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

NARDIL (phenelzine sulfate) is indicated in the treatment of depressed patients clinically characterized as "atypical", "nonendogenous" or "neurotic". These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness for severely depressed patients with endogenous features. NARDIL is indicated for patients who have failed to respond to the drugs more commonly used for these conditions.

Section 19A approved medicine:

METOCLOPRAMIDE HYDROCHLORIDE RENAUDIN 10 mg/2 mL, solution for injection in ampoule

Import and supply approved until: 31 July 2019

Medicine in short supply/unavailable:

  • Pfizer (Perth) metoclopramide hydrochloride monohydrate 10mg/2mL injection BP ampoule - ARTG 11364
  • MAXOLON metoclopramide hydrochloride monohydrate 10mg/2mL injection ampoule - ARTG 40204

Section 19A approval holder:

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Adults (20 years and over):

  • Relief of nausea and vomiting associated with migraine, cancer therapy (chemotherapy or radiation), malignant disease, labour, infectious disease and uraemia

  • Control of post-operative vomiting

    Metoclopramide is of little benefit for the prevention or treatment of motion sickness.

    Young Adults (under 20) and Children (over 1 year of age):

    Metoclopramide should only be used as second line therapy because of the risk of adverse effects:

  • Severe intractable vomiting of known cause

  • Vomiting associated with radiation therapy or intolerance to cytotoxic drugs
  • Section 19A approved medicine:

    Flucloxacillin 500mg Capsules (Athlone)

    Import and supply approved until: 28 February 2020

    Medicine in short supply/unavailable:

    • STAPHYLEX 500 FLUCLOXACILLIN 500mg (as sodium) capsule blister pack - ARTG 17684
    • APO-FLUCLOXACILLIN flucloxacillin (as sodium) 500 mg capsule blister pack - ARTG 226374
    • FLOPEN flucloxacillin 500mg (as sodium) capsule blister pack - ARTG 209368

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

    Section 19A approved medicine:

    Flucloxacillin 250mg capsules (Medreich)

    Import and supply approved until: 29 February 2020

    Medicine in short supply/unavailable:

    • STAPHYLEX 250 FLUCLOXACILLIN 250mg (as sodium) capsule blister pack - ARTG 17683
    • APO-FLUCLOXACILLIN flucloxacillin (as sodium) 250 mg capsule blister pack - ARTG 226382
    • FLOPEN flucloxacillin 250 mg (as sodium) capsule blister pack - ARTG 209367

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

    Section 19A approved medicine:

    DRAXIMAGE MAA kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection

    Import and supply approved until: 31 May 2020

    Medicine in short supply/unavailable:

    • DRAXIMAGE MAA kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection - ARTG 261212
    • RADPHARM MAA kit for the production of Technetium (99mTc) Macrosalb powder for injection multidose vial - ARTG 54860

    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

    Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients.

    Section 19A approved medicine:

    BCG Vaccine SSI - Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331 (AJ Vaccines) with Diluted Sauton SSI

    Import and supply approved until: 3 June 2020

    Medicine in short supply/unavailable:

    • BCG VACCINE Mycobacterium bovis (Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) (BCG) strain) 1.5mg powder for injection multidose vial with diluent vial - ARTG 53569

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Active immunisation against tuberculosis.

    BCG Vaccine SSI is to be used as per Australian national immunisation guidelines.

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