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Database of section 19A approvals to import and supply medicines to address medicine shortages
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.
TECHNELITE Technetium (Tc-99m) Generator
Medicine in short supply/unavailable:
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
Oxybutynin hydrochloride 5mg tablets (Morningside)
Medicine in short supply/unavailable:
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.
Daunorubicin (Zentiva) 20mg powder for IV injection
Medicine in short supply/unavailable:
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)
OMNIPAQUE 300 iohexol 20mL solution for injection (parametric release) (NZ)
Medicine in short supply/unavailable:
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.
Omnipaque 350 mgI/mL iohexol 200mL solution for injection (parametric release) (NZ)
Medicine in short supply/unavailable:
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.
Omnipaque 350 mgI/mL iohexol 100mL solution for injection (parametric release) (NZ)
Medicine in short supply/unavailable:
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.
Vaxigrip Tetra Quadrivalent influenza vaccine (split virion, inactivated) 0.5mL suspension for injection 2022 (International Presentation)
Medicine in short supply/unavailable:
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
FluQuadri Quadrivalent Influenza Vaccine, Types A and B subvirion, 0.5mL suspension for injection 2022 (International Presentation)
Medicine in short supply/unavailable:
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.
NARDIL phenelzine sulfate tablets USP, 15mg (Canada)
Medicine in short supply/unavailable:
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.
XENETIX 300 iobitridol 65.81g (658.1mg/mL) corresponding to iodine 300mg/mL solution for injection (Singapore)
Medicine in short supply/unavailable:
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