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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

11 July 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 100

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

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:

    Fentanyl 0.05 mg/ml solution for injection 100microgram in 2mL ampoules

    Import and supply approved until: 31 October 2019

    Medicine in short supply/unavailable:

    • ASPEN FENTANYL fentanyl (as citrate) 100 microgram/2 mL solution for injection - ARTG 170929
    • DBL FENTANYL 100 microgram/2mL (as citrate) injection USP ampoule - ARTG 107025
    • Fentanyl GH Solution for Injection 100 microgram/2 mL ampoule - ARTG 201872

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

  • Fentanyl Citrate is indicated for analgesic action of short duration during premedication, induction and maintenance of anaesthesia and in the immediate post-operative periods. It may be used as an opioid analgesic supplement in general and regional anaesthesia.

  • Fentanyl may be used in combination with neuroleptic agents as an anaesthetic premedication, for the induction of anaesthesia and as an adjunct in the maintenance of general and regional anaesthesia. The state of neurolept analgesia may be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen
  • 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.

    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:

    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:

    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:

    Dobutamine 12.5 mg/mL (250mg/20mL) concentrate for solution for infusion ampoule

    Import and supply approved until: 30 November 2019

    Medicine in short supply/unavailable:

    • DBL DOBUTAMINE 250mg/20mL (as hydrochloride) injection vial - ARTG 46451

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery

    Section 19A approved medicine:

    Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg Double Strength

    Import and supply approved until: 31 July 2019

    Medicine in short supply/unavailable:

    • RESPRIM FORTE tablet blister pack - ARTG 17682
    • SEPTRIN FORTE tablet blister pack - ARTG 10998

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Upper and lower respiratory tract infections, renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias and other infections caused by sensitive organisms.

    Section 19A approved medicine:

    Atropine Sulfate 600 micrograms in 1mL Solution for injection ampoule

    Import and supply approved until: 30 June 2019

    Medicine in short supply/unavailable:

    • Pfizer (Perth) ATROPINE INJECTION BP atropine sulfate monohydrate 600 microgram/1 mL injection BP ampoule - ARTG 11302

    Section 19A approval holder:

    Orpharma Pty Ltd ABN 19 157 901 267

    Approval holder phone number: 03 9863 7501

    • Preanaesthetic medication to reduce salivary secretions and bronchial secretions

    • to prevent cholinergic cardiac effects such as cardiac arrhythmias, hypotension and bradycardia

    • management of patients with acute myocardial infarction and sinus bradycardia who have associated hypotension and increased ventricular irritability

    • concurrent administration with anticholinesterase agents (e.g. neostigmine, physostigmine) to block the adverse muscarinic effects of these agents following surgery to terminate curarisation

    • for poisoning by organophosphate pesticides, atropine may be used concomitantly with a cholinesterase reactivator such as pralidoxime to reverse muscarinic effects.

    Section 19A approved medicine:

    Bleomycin for Injection, USP 15 units per vial

    Import and supply approved until: 31 January 2020

    Medicine in short supply/unavailable:

    • CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial - ARTG 220440
    • DBL BLEOMYCIN 15000IU (as sulfate) powder for injection vial - ARTG 42569
    • BLEO 15K bleomycin sulfate 15000 IU powder for injection vial - ARTG 157341

    Section 19A approval holder:

    Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430

    Approval holder phone number: 1300 077 674

    Palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms:

    • Squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication).

    • Squamous cell carcinoma of the larynx, penis and uterine cervix.

    • Squamous cell carcinoma of the bronchus (response infrequent).

    • Choriocarcinoma and embryonal cell carcinoma of the testis.

    • Advanced Hodgkin's disease and other lymphomas.

      Note: Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.

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