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

Database of section 19A approvals to import and supply medicines during a shortage

19 February 2019

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 81

Section 19A approved medicine:

Moxifloxacin-ratiopharm 400mg (moxifloxacin) film-coated tablets

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack - ARTG 75766

Picture of Moxifloxacin-ratiopharm 400mg tablets - carton

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Indications of the section 19A approved product

For the treatment of adults with infections caused by susceptible organisms in the conditions:

Acute bacterial sinusitis

Community acquired pneumonia

Acute exacerbations of chronic bronchitis

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with moxifloxacin may be initiated, in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy. Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

Section 19A approved medicine:

Carbidopa and Levodopa Extended-release tablets 50mg/200mg (carbidopa/levodopa 50mg/200mg)

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

SINEMET CR levodopa/carbidopa 200mg/50mg modified release tablet bottle - ARTG 171694

Picture of Carbidopa and Levodopa Extended-release tablets 50mg/200mg - bottle

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited in patients who have not been treated with levodopa before.

Section 19A approved medicine:

MORPHINE SULFATE INJECTION BP 30mg in 1mL, ampoule

Import and supply approved until: 30 June 2019

Medicine in short supply/unavailable:

DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule - ARTG 121755

Picture of Morphine sulfate injection 30mg/1mL - carton label

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Indications of the section 19A approved product

For the relief of severe pain not responsive to non-opioid analgesics.

Section 19A approved medicine:

Azithromycin for Injection, USP 500mg per vial, powder for solution (Auromedics)

Import and supply approved until: 11 March 2019

Medicine in short supply/unavailable:

AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial - ARTG 191947
ZITHROMAX IV azithromycin (as dihydrate) 500mg powder for injection vial - ARTG 91913
DBL AZITHROMYCIN FOR INJECTION azithromycin (as monohydrate) 500mg powder for injection vial - ARTG 161682

Picture of Azithromycin injection 500mg - carton

Picture of Azithromycin injection 500mg - vial

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

Section 19A approved medicine:

ADRENALINE RENAUDIN adrenaline 1 mg/mL solution for injection, 1mL ampoule

Import and supply approved until: 15 May 2019

Medicine in short supply/unavailable:

ADRENALINE-LINK 1:1,000 1mg/1mL adrenaline (epinephrine) acid tartrate injection BP ampoule - ARTG 12048

Picture of ADRENALINE RENAUDIN adrenaline 1mg/1mL - carton

Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Indications of the section 19A approved product

For the treatment of anaphylactic shock.

Section 19A approved medicine:

CARBIDOPA and LEVODOPA TABLETS, USP 25mg/250mg carbidopa/levodopa tablet bottle

Import and supply approved until: 30 April 2019

Medicine in short supply/unavailable:

SINEMET 250/25 levodopa/carbidopa 250mg/25mg tablet bottle - ARTG 171666

Picture of CARBIDOPA and LEVODOPA TABLETS USP 25mg/250mg - bottle

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 Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia.

Frequently helpful in the management of tremor, dysphagia, sialorrhoea and postural instability associated with Parkinson's disease and syndrome.

Section 19A approved medicine:

Pantoprazole Sodium for Injection, 40mg per vial

Import and supply approved until: 31 March 2019

Medicine in short supply/unavailable:

PANTOPRAZOLE SANDOZ pantoprazole (as sodium) 40mg powder for injection vial - ARTG 147377
PANTOPRAZOLE SUN pantoprazole (as sodium) 40mg powder for injection vial - ARTG 172172

Picture of Pantoprazole Sodium for Injection 40mg per vial - carton

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

For short-term use where oral therapy is not appropriate for the following conditions:

Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison Syndrome.

Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

Note: Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory medicines, whether on first presentation or recurrence

Section 19A approved medicine:

(Approval lapsed 11 December 2018) Nifedipine AL 10 (10 mg immediate-release nifedipine) capsules

Import and supply approved until: 1 January 2020

Medicine in short supply/unavailable:

ADALAT 10 nifedipine 10mg tablet blister pack - ARTG43103
ADEFIN 10 nifedipine 10mg tablet blister pack - ARTG 92999

Picture of Nifedipine AL 10 (10 mg)capsules - carton

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Chronic stable angina pectoris (angina)

Vasospastic angina (Prinzmetal's angina, variant angina)

Essential hypertension

Section 19A approved medicine:

(Approval lapsed 11 December 2018) Nifedipine AL T 20 Retard (20 mg modified-release nifedipine) tablets

Import and supply approved until: 19 April 2019

Medicine in short supply/unavailable:

ADALAT OROS nifedipine 20mg tablet blister pack - ARTG 60101

Picture of Nifedipine AL T 20 Retard (20mg modified-release) - carton

Medsurge Healthcare Pty Ltd ABN 92 124 728 892

Approval holder phone number: 1300 788 261

Indications of the section 19A approved product

Chronic stable angina pectoris (angina)

Vasospastic angina (Prinzmetal's angina, variant angina)

Essential hypertension

Section 19A approved medicine:

BCG-medac, powder and solvent for suspension for intravesical use

Import and supply approved until: 31 January 2020

Medicine in short supply/unavailable:

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

Picture of BCG-medac - vial carton label

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

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