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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 51 - 60 of 354

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 31 March 2021
Section 19A approved medicine:

(Approval lapsed) 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

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:

(Approval lapsed 05/05/2021) 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

Contraception

Import and supply approved until: 28 February 2021
Section 19A approved medicine:

(Approval lapsed) 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

  • 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:

    (Approval lapsed) 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

    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 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

    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 May 2021
    Section 19A approved medicine:

    (Approval lapsed) Carbimazole 5mg tablets (DAWA Ltd)


    Picture of Carbimazole 5mg tablets (DAWA Ltd) - carton label

    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

    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 October 2021
    Section 19A approved medicine:

    (Approval lapsed 05/03/2021) Pethidine 100mg/2mL Solution for Injection, 2mL ampoule (Martindale)


    Picture of Pethidine 100mg/2mL Solution for Injection
    Picture of Pethidine 100mg/2mL Solution for Injection

    Medicine in short supply/unavailable:

    • DBL PETHIDINE HYDROCHLORIDE 100mg/2mL injection BP ampoule - ARTG 107387

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

    Approval holder phone number: 1800 181 060

    Pethidine 50 mg/mL Solution for Injection ampoules (50 mg/mL & 100 mg/2 mL) are approved for use under Section 19A for the following indications:

    • For short term (24 to 36 hours) management of severe pain

  • For administration as an anaesthetic adjunct and for obstetric analgesia
  • Import and supply approved until: 31 October 2021
    Section 19A approved medicine:

    (Approval lapsed) 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

    • 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)
  • Import and supply approved until: 31 March 2021
    Section 19A approved medicine:

    (Approval lapsed) PARNATE Tranylcypromine tablets USP 10mg (GSK)


    Picture of PARNATE Tranylcypromine tablets USP 10mg (GSK) - bottle label

    Medicine in short supply/unavailable:

    • PARNATE tranylcypromine (as sulphate) 10mg film coated tablet blister pack - ARTG 174086

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

    Approval holder phone number: 1300 788 261

    Tranylcypromine sulfate is indicated for the treatment of symptoms of depressive illness especially where treatment with other types of antidepressants has failed. It is not recommended for use in mild depressive states resulting from temporary situational difficulties.

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

    (Approval lapsed) Famotidine 40mg 28 tablet blister pack - Tillomed


    Picture of Famotidine 40mg 28 tablet blister pack - Tillomed - carton label

    Medicine in short supply/unavailable:

    • AUSFAM 40 famotidine 40mg tablet blister pack - ARTG 93789

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

    Approval holder phone number: 1800 181 060

    • Duodenal ulcer
    • Benign gastric ulcer
    • Zollinger-Ellison syndrome
    • Prevention of relapses of duodenal ulceration
    • Short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures

  • Healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease
  • Prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease
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