Source: https://www.tga.gov.au/ws-s19a-index?search_api_views_fulltext=&field_s19a_status=All&sort_by=field_date&items_per_page=10
Timestamp: 2019-11-13 12:26:27
Document Index: 110463151

Matched Legal Cases: ['ARTG 174086', 'ARTG 227783', 'ARTG 227784', 'ARTG 180894', 'ARTG 11376', 'ARTG 61887', 'ARTG 69076', 'ARTG 72820', 'ARTG 75859', 'ARTG 72931', 'ARTG 11231', 'ARTG 14463']

Database of section 19A approvals to import and supply medicines to address medicine shortages | Therapeutic Goods Administration (TGA)
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Database of section 19A approvals to import and supply medicines during a shortage
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.
Section 19A approvals
Enter an approval holder, product name, active ingredient, indication or ARTG number.
- Any -CurrentExpired/Lapsed
Sort by Publication dateExpiry dateApproved productReplaced productApproval holder
Section 19A approved medicine:
Tranylcypromine tablets 10mg (Mercury Pharmaceuticals)
Import and supply approved until: 31 January 2020
Medicine in short supply/unavailable:
PARNATE tranylcypromine (as sulphate) 10mg film coated tablet blister pack - ARTG 174086
Section 19A approval holder:
Boucher and Muir Pty Ltd trading as BNM Group ABN 58 000 140 474
Approval holder phone number: 02 9431 6333
Indications of the section 19A approved product
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.
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/tr...
Nitrostat 0.3mg sublingual tablets (Canada)
ANGININE glyceryl trinitrate 600microgram tablet bottle - ARTG 227783
LYCINATE glyceryl trinitrate 600microgram tablet bottle - ARTG 227784
Pfizer Australia Pty Ltd ABN 50 00 8422 348
Approval holder phone number: 1800 675 229
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/gl...
Cyclizine Lactate 50 mg/ml solution for Injection (Pack of 5 x 1mL ampoules)
VALOID cyclizine lactate 50 mg/1 mL injection ampoule - ARTG 180894
Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number: 1300 788 261
For the prevention of nausea and vomiting caused by narcotic analgesics and general anaesthetics in the post-operative period
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/cy...
Gentamicin Injection USP 80mg/2mL solution for injection - 10 ampoules
Import and supply approved until: 29 February 2020
GENTAMICIN INJECTION B.P. 80mg/2mL - ARTG 11376
Link Medical Products Pty Ltd ABN 73 010 971 517
Approval holder phone number: 1800 181 060
For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics).
Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics.
In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk of toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/ge...
GENTAMICIN INJECTION USP 80mg/2mL solution for injection contains preservative therefore it may cause airway irritation if administered via inhalation. A safety advisory regarding this issue is available at https://www.tga.gov.au/alert/gentamicin-injection-...
Leucovorin Calcium for Injection 100mg Powder for solution
Pfizer (Perth) LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 100mg/10mL injection USP ampoule - ARTG 61887
Following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/ca...
Rizatriptan 10mg Orodisperible Tablets (Actavis)
Import and supply approved until: 15 January 2020
MAXALT rizatriptan (as benzoate) 10mg wafer blister pack - ARTG 69076
For the acute treatment of migraine attacks with or without aura
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/ri...
Import and supply approved until: 15 February 2020
GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate (99mTc) injection multidose vial - ARTG 72820
GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechnetate (99mTc) 370GBq injection multidose vial - ARTG 75859
Australian Nuclear Science and Technology Organisation T/A ANSTO ABN 47 956 969 590
Approval holder phone number: 1800 251 572
Sodium pertechnetate [99mTc] is used for scintigraphy, principally of the brain and thyroid. It can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/so...
KamRAB 150 IU/ml Solution for Injection (Human Rabies immunoglobulin)
Import and supply approved until: 31 January 2021
IMOGAM RABIES PASTEURIZED human rabies immunoglobulin 150 IU/mL injection vial - ARTG 72931
KamRAB 150 IU/mL Solution for injection - 2mL vial (Human Rabies immunoglobulin) in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine.
Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated).
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/ra...
APO-Primidone 250mg tablets (100 tablets)
Import and supply approved until: 31 August 2020
MYSOLINE primidone 250mg tablet bottle - ARTG 11231
Link Medical Products Pty Ltd ABN 73 010 971 516
The management of grand mal and psychomotor (temporal lobe) epilepsy.
It is also of value in the management of focal or Jacksonian seizures, myoclonic jerks and akinetic attacks.
Related medicine shortages: https://apps.tga.gov.au/Prod/msi/Search/Details/pr...
Tranexamic Acid 500 mg Tablets Sovereign Medical
Import and supply approved until: 13 January 2020
CYKLOKAPRON tranexamic acid 500mg tablet bottle - ARTG 14463
Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery.
URL:https://www.tga.gov.au/ws-s19a-index