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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

27 March 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 88

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

Section 19A approved medicine:

Dicloxacillin Sodium Capsules USP 500mg

Import and supply approved until: 1 August 2019

Medicine in short supply/unavailable:

  • DISTAPH 500 dicloxacillin 500mg (as sodium) capsule bottle - ARTG 226508
  • DICLOXACILLIN MYLAN 500 dicloxacillin (as sodium) 500 mg capsule bottle - ARTG 289107

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 skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).

Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin.

Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.

Important Note: When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin.

Section 19A approved medicine:

Azithromycin for Injection, USP 500mg powder for solution (Athenex)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

  • AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial - ARTG 191947
  • ZITHROMAX IV azithromycin (as dihydrate) 500mg powder for injection vial - ARTG 91913
  • DBL AZITHROMYCIN FOR INJECTION azithromycin (as monohydrate) 500mg powder for injection vial - ARTG 161682

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

Section 19A approved medicine:

Dicloxacillin Sodium Capsules USP 250mg

Import and supply approved until: 1 August 2019

Medicine in short supply/unavailable:

  • DISTAPH 250 dicloxacillin 250mg (as sodium) capsule bottle - ARTG 226506
  • DICLOXACILLIN MYLAN 250 dicloxacillin (as sodium) 250 mg capsule bottle - ARTG 289105

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 skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).

Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin.

Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.

Important Note: When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin.

Section 19A approved medicine:

HydrALAZINE Hydrochloride Tablets, USP, 25mg (hydralazine hydrochloride) tablets

Import and supply approved until: 30 May 2019

Medicine in short supply/unavailable:

  • ALPHAPRESS 25 hydralazine hydrochloride 25mg tablet bottle - ARTG 17575
  • ALPHAPRESS 50 hydralazine hydrochloride 50mg tablet bottle - ARTG 60380

Section 19A approval holder:

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Treatment of drug resistant, moderate to severe, hypertension. This drug is not a first line antihypertensive drug and is better used in combination with other antihypertensives such as beta-blockers and diuretics.

Section 19A approved medicine:

Pethidine 50mg/mL Solution for Injection, 1mL ampoule

Import and supply approved until: 31 August 2019

Medicine in short supply/unavailable:

  • DBL PETHIDINE HYDROCHLORIDE 50mg/1mL injection BP ampoule - ARTG 107386
  • 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:

    FERODAN ferrous sulfate oral solution, USP 30mg/mL (250mL bottle)

    Import and supply approved until: 30 June 2019

    Medicine in short supply/unavailable:

    • FERRO-LIQUID ferrous sulfate heptahydrate 30mg/mL oral liquid solution bottle - ARTG 154466

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Source of iron for iron deficiency and iron deficiency anaemias.

    Section 19A approved medicine:

    ZEDBAC azithromycin 500 mg powder for solution for infusion

    Import and supply approved until: 31 January 2020

    Medicine in short supply/unavailable:

    • AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial - ARTG 191947
    • ZITHROMAX IV azithromycin (as dihydrate) 500mg powder for injection vial - ARTG 91913
    • DBL AZITHROMYCIN FOR INJECTION azithromycin (as monohydrate) 500mg powder for injection vial - ARTG 161682

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

    Section 19A approved medicine:

    Carbidopa and Levodopa Extended-release tablets 50mg/200mg (carbidopa/levodopa 50mg/200mg)

    Import and supply approved until: 31 January 2020

    Medicine in short supply/unavailable:

    • SINEMET CR levodopa/carbidopa 200mg/50mg modified release tablet bottle - ARTG 171694

    Section 19A approval holder:

    Medsurge Healthcare Pty Ltd ABN 92 124 728 892

    Approval holder phone number: 1300 788 261

    Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited in patients who have not been treated with levodopa before.

    Section 19A approved medicine:

    MORPHINE SULFATE INJECTION BP 30mg in 1mL, ampoule

    Import and supply approved until: 30 June 2019

    Medicine in short supply/unavailable:

    • DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule - ARTG 121755

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    For the relief of severe pain not responsive to non-opioid analgesics.

    MORPHINE SULFATE INJECTION BP 30mg in 1mL, ampoule contains preservative therefore it is not to be used for either epidural or intrathecal routes. A safety advisory regarding this issue is available at https://www.tga.gov.au/alert/morphine-sulfate-inje....

    Section 19A approved medicine:

    Moxifloxacin-ratiopharm 400mg (moxifloxacin) film-coated tablets

    Import and supply approved until: 31 January 2020

    Medicine in short supply/unavailable:

    • AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack - ARTG 75766

    Section 19A approval holder:

    Link Medical Products Pty Ltd ABN 73 010 971 516

    Approval holder phone number: 1800 181 060

    For the treatment of adults with infections caused by susceptible organisms in the conditions:

  • Acute bacterial sinusitis

  • Community acquired pneumonia

  • Acute exacerbations of chronic bronchitis

    Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with moxifloxacin may be initiated, in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy. Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

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