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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 81 - 90 of 354

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) PIRMELLA 1/35 norethisterone 1mg and ethinylestradiol 35 microgram tablets (3 blisters of 28 tablets) (Lupin Pharmaceuticals)


Picture of PIRMELLA-1/35 norethisterone 1mg and ethinylestradiol 35 microgram tablets (3 blisters of 28 tablets) (Lupin Pharmaceuticals) - carton label
Picture of PIRMELLA-1/35 norethisterone 1mg and ethinylestradiol 35 microgram tablets (3 blisters of 28 tablets) (Lupin Pharmaceuticals) - tablet strip 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: 30 November 2020
Section 19A approved medicine:

(Approval lapsed) Suxamethonium Chloride 50mg/ml Solution for injection 10x2mL Ampoules (Martindale Pharmaceuticals UK)


Picture of Suxamethonium Chloride50mg/ml Solution for injection 10x2mL Ampoules Martindale Pharmaceuticals UK carton label
Picture of Suxamethonium Chloride50mg/ml Solution for injection 10x2mL Ampoules Martindale Pharmaceuticals UK ampoule label

Medicine in short supply/unavailable:

  • SUXAMETHONIUM JUNO 100mg/2mL injection ampoule - ARTG 32067

Section 19A approval holder: Juno Pharmaceuticals Pty Ltd ABN 55 156 303 650

Approval holder phone number: 03 8888 1288

For the production of skeletal muscle relaxation in anaesthesia. Suited for procedures requiring only brief relaxation such as endotracheal intubation, endoscopic examinations, orthopaedic manipulations, short surgical procedures and electro-convulsive therapy.

Import and supply approved until: 31 January 2021
Section 19A approved medicine:

(Approval lapsed) TRANEXAMIC ACID (Tranexamic acid) 500MG TABLETS


Picture of TRANEXAMIC ACID (Tranexamic acid) 500MG TABLETS carton

Medicine in short supply/unavailable:

  • CYKLOKAPRON tranexamic acid 500mg tablet bottle - ARTG 144653

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

Approval holder phone number: 1300 788 261

  • Hereditary angioneurotic oedema

  • Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery
  • Menorrhagia
  • Import and supply approved until: 2 December 2020
    Section 19A approved medicine:

    (Approval lapsed) Olmesartan medoxomil 40mg film coated tablets (Accord)


    Picture of Olmesartan medoxomil 40mg film coated tablets (Accord) - Carton

    Medicine in short supply/unavailable:

    • OLMESARTAN - MYL olmesartan medoxomil 40 mg tablet blister pack - ARTG 273572
    • OLMETEC olmesartan medoxomil 40 mg tablet blister pack - ARTG 102139

    Section 19A approval holder: Link Medical Products Pty Ltd ABN 730 109 715 16

    Approval holder phone number: 1800 181 060

    For the treatment of hypertension

    Import and supply approved until: 15 December 2020
    Section 19A approved medicine:

    (Approval lapsed) NeoMercazole carbimazole 5mg tablets 100 bottle (Malaysia)


    Picture of NeoMercazole carbimazole 5mg tablets 100 bottle (Malaysia) - bottle label
    Picture of NeoMercazole carbimazole 5mg tablets 100 bottle (Malaysia) - carton

    Medicine in short supply/unavailable:

    • NEO-MERCAZOLE carbimazole 5mg tablet bottle - ARTG 194296

    Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd ABN 91 118 106 684

    Approval holder phone number: 1800 627 680

    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) Carbimazole 5mg Tablets (AMDIPHARM UK)


    Picture of Carbimazole 5mg Tablets (AMDIPHARM UK) - carton

    Medicine in short supply/unavailable:

    • NEO-MERCAZOLE carbimazole 5mg tablet bottle

    Section 19A approval holder: Amdipharm Mercury (Australia) Pty Ltd ABN 91 118 106 684

    Approval holder phone number: 1800 627 680

    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: 30 June 2021
    Section 19A approved medicine:

    (Approval lapsed) Epirubicin Accord epirubicin hydrochloride 200mg/100mL Solution for Injection or Infusion (Austria)


    Medicine in short supply/unavailable:

    • EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL concentrated injection vial - ARTG 227997

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

    Approval holder phone number: 1800 222 673

    Epirubicin is used in the treatment of a range of neoplastic conditions including:

    • Carcinoma of the breast
    • Gastric cancer Intravesical administration
    • Treatment of papillary transitional cell carcinoma of the bladder
    • Treatment of carcinoma-in-situ of the bladder
    • Prophylaxis of recurrences after transurethral resection of superficial tumours
    Import and supply approved until: 31 January 2021
    Section 19A approved medicine:

    (Approval lapsed) PHENYTOIN SODIUM INJECTION USP 250mg/5mL solution for injection (Sterimax)


    Picture of PHENYTOIN SODIUM INJECTION 250mg/5mL solution for injection-vial
    Picture of PHENYTOIN SODIUM INJECTION 250mg/5mL solution for injection-carton

    Medicine in short supply/unavailable:

    • DBL PHENYTOIN INJECTION BP 250mg/5mL ampoule - ARTG 46943

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

    Approval holder phone number: 1800 181 060

    For the control of tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery.

    Import and supply approved until: 31 January 2021
    Section 19A approved medicine:

    (Approval lapsed 18/08/2020) PHENYTOIN SODIUM INJECTION USP 100mg/2mL solution for injection (Sterimax)


    Picture of PHENYTOIN SODIUM INJECTION 100mg/2mL solution for injection-vial
    Picture of PHENYTOIN SODIUM INJECTION 100mg/2mL solution for injection-carton

    Medicine in short supply/unavailable:

    • DBL PHENYTOIN INJECTION BP 100mg/2mL ampoule - ARTG 46942

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

    Approval holder phone number: 1800 181 060

    For the control of tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery.

    Import and supply approved until: 31 July 2021
    Section 19A approved medicine:

    (Approval lapsed) Isoproterenol Hydrochloride Injection, USP 1mg/5 mL solution for injection ampoule


    Picture of Isopreterenol HCL USP Injection 1mg/5mL - Carton
    Picture of Isopreterenol HCL USP Injection 1mg/5mL - vial

    Medicine in short supply/unavailable:

    • Isuprel 1:5000 1mg/5mL injection - ARTG 198888

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

    Approval holder phone number: 0478 061 879

    For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.

    For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).

    For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available.

    For bronchospasm occurring during anesthesia.

    As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output

    (hypoperfusion) states, congestive heart failure, and cardiogenic shock.

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