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

11 February 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.

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 228

Import and supply approved until: 31 January 2022

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

Indications of the section 19A approved product

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 2021

Section 19A approved medicine: Carbimazole 5mg tablets (Morningside Healthcare)

Picture of Carbimazole 5mg tablets (Morningside Healthcare)

Medicine in short supply/unavailable:

Carbimazole Neo-Mercazole 5mg tablets bottle of 100 - ARTG 194296

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

Approval holder phone number: 1301 788 261

Indications of the section 19A approved product

Therapy of hyperthyroidism. Definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. Preparation for thyroidectomy. Before and after radioactive iodine treatment.

Import and supply approved until: 31 May 2021

Section 19A approved medicine: ALYACEN 1/35 norethisterone 1mg and ethinylestradiol 35mcg tablets (3 blisters of 28 tablets) (Glenmark Pharmaceuticals)

Picture of Alyacen 1/35 norethisterone 1mg and ethinylestradiol 35mcg tablets (3 blisters of 28 tablets) (Glenmark Pharmaceuticals) label

Medicine in short supply/unavailable:

NORIMIN-1 28 day tablet blister pack - ARTG 62136
BREVINOR-1 28 DAY tablet blister pack - ARTG 62134

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

Contraception

Import and supply approved until: 31 January 2022

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

Indications of the section 19A approved product

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

Import and supply approved until: 28 February 2021

Section 19A approved medicine: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd)

Picture of Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd) - carton and bottle

Medicine in short supply/unavailable:

TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200 tenofovir disoproxil maleate300 mg and emtricitabine 200 mg film coated tablet bottle - ARTG 265834

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

Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents

Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil is indicated in combination with safer sex practices for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples

Import and supply approved until: 30 June 2021

Section 19A approved medicine: Sertraline 100mg tablets, USP (Cipla)

Picture of Sertraline 100mg tablets USP (Cipla) - label

Medicine in short supply/unavailable:

APO-SERTRALINE sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 213180
SERTRALINE SANDOZ sertraline (as hydrochloride) 100 mg flim coated tablet blister pack - ARTG 98698
ELEVA 100 sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 95583

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

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: Sertraline 50mg tablets, USP (Cipla)

Picture of Sertraline 50mg tablets USP (Cipla) - label

Medicine in short supply/unavailable:

APO-SERTRALINE sertraline (as hydrochloride) 50 mg tablet blister pack - ARTG 213177

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

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 March 2021

Section 19A approved medicine: Carbimazole 5mg tablets (DAWA Ltd)

Medicine in short supply/unavailable:

Carbimazole Neo-Mercazole 5mg tablets bottle of 100 - ARTG 194296

Section 19A approval holder: Seed Pharma Pty Ltd ABN 81 612 154 373

Approval holder phone number: 1300 966 356

Indications of the section 19A approved product

Import and supply approved until: 19 June 2021

Section 19A approved medicine: TECHNELITE Technetium (Tc-99m) Generator

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

Import and supply approved until: 31 October 2021

Section 19A approved medicine: EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (UK)

Picture of EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (UK) - carton label

Picture of EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (UK) - vial label

Medicine in short supply/unavailable:

EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL concentrated injection vial - ARTG 227997
PHARMORUBICIN epirubicin hydrochloride 200mg/100mL injection vial - ARTG 49746
EPIRUBICIN AN epirubicin hydrochloride 200 mg/100 mL concentrated injection vial - ARTG 146599

Section 19A approval holder: Accord Healthcare Pty Ltd ABN 49 110 502 513

Approval holder phone number: 1800 222 673

Indications of the section 19A approved product

Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases. Epirubicin Hydrochloride injection is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma and superficial bladder cancer (Tis, Ta)

In bladder cancer, Epirubicin Hydrochloride injection is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (grade 2 and 3)

Therapeutic Goods Administration (TGA)

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Standard conditions of approval

Section 19A approvals

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