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

21 September 2021

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 - 3 of 3

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 30 April 2021
Section 19A approved medicine:

(Approval lapsed) Fluoxetine tablets USP 20mg (Dr Reddy's) 30 tablet bottle


Medicine in short supply/unavailable:

  • Prozac Fluoxetine 20mg tablets - ARTG 61081 - Discontinued
  • LOVAN TAB Fluoxetine (as hydrochloride) 20mg tablet blister pack - ARTG 61080

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

Approval holder phone number: 1300 788 261

Treatment of Major depression and Obsessive Compulsive Disorder.

Import and supply approved until: 30 April 2021
Section 19A approved medicine:

(Approval Lapsed) Fluoxetine capsules USP 20mg (ScieGen) 100 capsule bottle


Medicine in short supply/unavailable:

  • PROZAC 20 fluoxetine 20mg (as hydrochloride) capsule - ARTG 14653
  • LOVAN fluoxetine 20mg (as hydrochloride) capsule - ARTG 54700

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

Approval holder phone number: 1300 788 261

Treatment of Major depression and Obsessive Compulsive Disorder

Import and supply approved until: 30 April 2021
Section 19A approved medicine:

(Approval Lapsed) Fluoxetine 20mg capsules (Strides Pharma)


Medicine in short supply/unavailable:

  • PROZAC 20MG CAPSULE - ARTG 14653
  • LOVAN fluoxetine 20mg (as hydrochloride) capsule - ARTG 54700

Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 517

Approval holder phone number: 1800 181 060

Depression: Fluoxetine is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required.

Obsessive-compulsive disorder.

Bulimia nervosa: Fluoxetine is indicated for the reduction of binge-eating and purging activity.

Pre-menstrual Dysphoric Disorder (PMDD)

Diagnosis of PMDD: The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective lability, accompanied by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) - all of which must be severe. This syndrome should be distinguished from the commoner 'pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)' and from any co-existing psychiatric disorder.