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Database of section 19A approvals to import and supply medicines to address medicine shortages

22 June 2022

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.

Standard conditions of approval

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.
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Section 19A approvals

Displaying 1 - 10 of 336

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 19 June 2021
Section 19A approved medicine:

TECHNELITE Technetium (Tc-99m) Generator
Picture of Technelite Technetium (Tc99m) generator - canister label

Medicine in short supply/unavailable:

  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate - ARTG 72820
  • GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechneta - ARTG 75859
  • TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) - ARTG 130301

Section 19A approval holder: Global Medical Solutions Australia Pty Limited ABN 66 072 147 561

Approval holder phone number: 02 9503 8100

Indications of the section 19A approved product

Technetium [99mTc] Generator is used for the preparation of Sodium Pertechnetate [99mTc] Injection.

Sodium Pertechnetate [99mTc] is used as an agent for:

  • Brain Imaging,
  • Thyroid Imaging,

  • Salivary Gland Imaging and

  • Blood Pool Imaging

Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/so...
Import and supply approved until: 31 January 2023
Section 19A approved medicine:

Oxybutynin hydrochloride 5mg tablets (Morningside)

Medicine in short supply/unavailable:

  • DITROPAN oxybutynin hydrochloride 5mg tablet bottle AUST R: 48965

Section 19A approval holder: Reach Pharmaceuticals ABN: 25 623 897 183

Approval holder phone number: 0478 061 879

Indications of the section 19A approved product

Treatment of detrusor over-activity where conservative measures have failed.

Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/ox...
Import and supply approved until: 31 July 2022
Section 19A approved medicine:

Daunorubicin (Zentiva) 20mg powder for IV injection

Medicine in short supply/unavailable:

  • Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial

Section 19A approval holder: Link Medical Products Pty Ltd ABN: 73 010 971 516

Approval holder phone number: 1800 181 060

Indications of the section 19A approved product

  • Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.

  • Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g., cytarabine)

Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/da...
Import and supply approved until: 28 February 2023
Section 19A approved medicine:

OMNIPAQUE 300 iohexol 20mL solution for injection (parametric release) (NZ)

Medicine in short supply/unavailable:

  • OMNIPAQUE 300 iohexol 12.94g/20mL injection vial AUST R: 48220

Section 19A approval holder: GE Healthcare Pty Ltd ABN: 32 001 408 402

Approval holder phone number: 1300 887 764

Indications of the section 19A approved product

Intravascular: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography.

Oral/body cavities: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract.

Intrathecal: OMNIPAQUE is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the CNS in adults and children.

Import and supply approved until: 28 February 2023
Section 19A approved medicine:

Omnipaque 350 mgI/mL iohexol 200mL solution for injection (parametric release) (NZ)

Medicine in short supply/unavailable:

  • OMNIPAQUE 350 iohexol 15.1g/20mL injection vial AUST R: 39868

Section 19A approval holder: GE Healthcare Pty Ltd ABN: 32 001 408 402

Approval holder phone number: 1300 887 764

Indications of the section 19A approved product

Intravascular: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography.

Oral/body cavities: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract.

Intrathecal: OMNIPAQUE is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the CNS in adults and children.

Import and supply approved until: 28 February 2023
Section 19A approved medicine:

Omnipaque 350 mgI/mL iohexol 100mL solution for injection (parametric release) (NZ)

Medicine in short supply/unavailable:

  • OMNIPAQUE 350 iohexol 15.1g/20mL injection vial AUST R: 39868

Section 19A approval holder: GE Healthcare Pty Ltd ABN: 32 001 408 402

Approval holder phone number: 1300 887 764

Indications of the section 19A approved product

Intravascular: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography.

Oral/body cavities: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract.

Intrathecal: OMNIPAQUE is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the CNS in adults and children.

Import and supply approved until: 31 December 2022
Section 19A approved medicine:

Vaxigrip Tetra Quadrivalent influenza vaccine (split virion, inactivated) 0.5mL suspension for injection 2022 (International Presentation)

Medicine in short supply/unavailable:

  • VAXIGRIP TETRA Inactivated Quadrivalent Influenza Vaccine (Split Virion) influenza virus HA 60 mcg 0.5 mL suspension for injection

Section 19A approval holder: Sanofi-Aventis Australia Pty Ltd ABN: 31 008 558 807

Approval holder phone number: 1800 818 806

Indications of the section 19A approved product

Vaxigrip Tetra is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for:

  • active immunisation of adults, including pregnant women, and children from 6 months of age and older
  • passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women
Import and supply approved until: 15 January 2023
Section 19A approved medicine:

FluQuadri Quadrivalent Influenza Vaccine, Types A and B subvirion, 0.5mL suspension for injection 2022 (International Presentation)

Medicine in short supply/unavailable:

  • FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for injection 2022 - ARTG 213963

Section 19A approval holder: Sanofi-Aventis Australia Pty Ltd ABN 31 008 558 807

Approval holder phone number: 1800 818 806

Indications of the section 19A approved product

FluQuadri is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

FluQuadri is indicated for use in adults and children 6 months and older.

Import and supply approved until: 30 September 2023
Section 19A approved medicine:

NARDIL phenelzine sulfate tablets USP, 15mg (Canada)

Medicine in short supply/unavailable:

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

Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN: 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

For the treatment of major depression.

Phenelzine sulfate should rarely be the first antidepressant drug used. Rather it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.

Import and supply approved until: 28 February 2023
Section 19A approved medicine:

XENETIX 300 iobitridol 65.81g (658.1mg/mL) corresponding to iodine 300mg/mL solution for injection (Singapore)

Medicine in short supply/unavailable:

  • non - ionic CONTRAST MEDIA SHORTAGE

Section 19A approval holder: Guerbet Australia Pty Ltd ABN: 15 159 798 302

Approval holder phone number: 02 8075 3007

Indications of the section 19A approved product

XENETIX 300 iobitridol 65.81g (658.1mg/mL) corresponding to iodine 300mg/mL solution for injection (Singapore) is for diagnostic use only.

Contrast agent to be used in adults for:

  • Intravenous urography
  • intravenous digital subtraction angiography
  • arthrography
  • hysterosalpingography

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