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

4 August 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.

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 41 - 50 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 October 2022
Section 19A approved medicine:

IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (Korean presentation)


Picture of IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (Korean presentation) - Carton
Picture of IMOJEV (Korean presentation) - vial label
Picture of IMOJEV (Korean presentation) - diluent label

Medicine in short supply/unavailable:

  • IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial AUST R: 162215

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

Approval holder phone number: 1800 818 806

Indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over

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

IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (Thailand presentation)


Picture of IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (Thailand presentation)
Picture of IMOJEV (Thailand presentation) - vial label
Picture of IMOJEV (Thailand presentation) - diluent label

Medicine in short supply/unavailable:

  • IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial AUST R: 162215

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

Approval holder phone number: 1800 818 806

Indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.

Import and supply approved until: 15 February 2023
Section 19A approved medicine:

Panzytrat 25,000 Pancreatin capsule vial (Allergan)


Medicine in short supply/unavailable:

  • PANZYTRAT 25000 Pancrelipase capsule bottle - AUST R 55941

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

Approval holder phone number: 1300 788 261

For pancreatic enzyme replacement in patients aged 18 months or more suffering with conditions associated with pancreatic exocrine insufficiency such as cystic fibrosis, chronic pancreatitis, post pancreatectomy, post-gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy) and ductal obstruction.

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

APO-Varenicline 1mg tablets (Canada)


Medicine in short supply/unavailable:

  • CHAMPIX varenicline (as tartrate) 1.0mg tablet blister pack AUST R 124941

Section 19A approval holder: Apotex Pty Ltd ABN 52 096 916 148

Approval holder phone number: 1800 276 839

Indicated as an aid to smoking cessation in adults over the age of 18 years.

Import and supply approved until: 30 September 2022
Section 19A approved medicine:

Thiotepa for Injection, USP 100mg/vial (Novadoz)


Medicine in short supply/unavailable:

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

Approval holder phone number: 0478 061 879

As conditioning treatment prior to haematopoietic progenitor cell transplantation

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

Xylocaine 2% with Epinephrine - lidocaine hydrochloride and epinephrine injection USP 20mL vial (Aspen)


Medicine in short supply/unavailable:

  • Xylocaine 2.0% with adrenaline (epinephrine) 1:200,000 20mL injection vial - ARTG -12021

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

Approval holder phone number: 1300 788 261

XYLOCAINE solutions are indicated for the production of local or regional anaesthesia by the following techniques:

  • infiltration,
  • intravenous regional anaesthesia - excluding solutions with adrenaline (epinephrine) acid tartrate,
  • peripheral nerve block such as intercostal block,
  • major plexus block such as brachial plexus block,
  • epidural block,
  • subarachnoid block

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

(Approval lapsed) Sertraline 50mg film-coated tablets (Ranbaxy UK)


Picture of Sertraline 50 mg film-coated tablets (Ranbaxy UK) label

Medicine in short supply/unavailable:

  • APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack - ARTG 213177
  • SETRONA sertraline (as hydrochloride) 50 mg tablet blister pack - ARTG 116623
  • SERTRALINE-STR sertraline (as hydrochloride) 50 mg tablet blister pack - ARTG 107067
  • SERTRALINE SANDOZ sertraline 50mg (as hydrochloride) film coated tablet blister pack - ARTG 98697
  • SERTRALINE GENERICHEALTH sertraline 50mg (as hydrochloride) tablet blister pack - ARTG 124855

Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066

Approval holder phone number: 0427 902 599

Indicated for the treatment of children (aged 6 years of age and older) and adolescents with obsessive compulsive disorder (OCD).

Indicated in adults for the treatment of:

  • Major depression
  • Obsessive compulsive disorder (OCD)
  • Panic disorder
  • Social phobia (social anxiety disorder) and the prevention of its relapse
  • Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
Import and supply approved until: 30 June 2021
Section 19A approved medicine:

(Approval lapsed) Sertraline 100mg film-coated tablets (Ranbaxy UK)


Picture of Sertraline 100 mg film-coated tablets (Ranbaxy UK) label

Medicine in short supply/unavailable:

  • APO-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack - ARTG 213180
  • ELEVA 100 sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 95583
  • SERTRALINE SANDOZ sertraline 100mg (as hydrochloride) film coated tablet blister pack - ARTG 98698
  • SERTRA 100 sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 213181
  • SETRONA sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 116636
  • ZOLOFT sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 321602
  • SERTRALINE GENERICHEALTH sertraline 100mg (as hydrochloride) tablet blister pack - ARTG 124856

Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066

Approval holder phone number: 0427 902 599

Indicated for the treatment of children (aged 6 years of age and older) and adolescents with obsessive compulsive disorder (OCD).

Indicated in adults for the treatment of:

  • Major depression
  • Obsessive compulsive disorder (OCD)
  • Panic disorder
  • Social phobia (social anxiety disorder) and the prevention of its relapse
  • Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
Import and supply approved until: 31 January 2024
Section 19A approved medicine:

BCG Culture SSI 30mg/vial (AJ Vaccines)


Picture of BCG Culture SSI 30mg/vial (AJ Vaccines) carton label
Picture of BCG Culture SSI 30mg/vial (AJ Vaccines) vial label

Medicine in short supply/unavailable:

  • ONCOTICE BCG 5 hundred million CFU powder for injection vial - ARTG 59912

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

Approval holder phone number: 1800 181 060

Treatment of primary or recurrent carcinoma in situ (CIS) of the urinary bladder.

Intravesicular BCG is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage TA [grade 2 or 3] or T1 [grade 1, 2, or 3]).

Intravesicular BCG is only recommended for stage TA grade 1 tumours, when there is judged to be a high risk of tumour recurrence.

Import and supply approved until: 31 March 2023
Section 19A approved medicine:

Desmopressin Nasal Spray 10mcg/0.1mL (Apotex)


Picture of Desmopressin Acetate Nasal Spray 10mcg/0.1mL (Apotex) label

Medicine in short supply/unavailable:

  • MINIRIN desmopressin acetate 10 microgram/ actuation nasal spray - ARTG 59320

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

Approval holder phone number: 1300 788 261

  • The treatment of ADH sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria

  • Nocturnal Enuresis: The symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. Should be used only in patients who are refractory to the enuresis alarm or in patients in whom enuresis alarm is ontraindicated or inappropriate, and where the oral administration of desmopressin is not feasible
  • Renal Concentrating Capacity By intranasal administration to adults and children as a diagnostic test to establish renal concentrating capacity
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