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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.
Import and supply approved until:
28 February 2023
Section 19A approved medicine:
ULTRAVIST 300 iopromide 62.34g/100mL (equivalent to 300 mg/1 mL of organically bound iodine) solution for injection (Vietnam)
Medicine in short supply/unavailable:
Section 19A approval holder: Bayer Australia Ltd ABN: 22 000 138 714
Approval holder phone number: 1800 008 757
Import and supply approved until:
28 February 2023
Section 19A approved medicine:
XENETIX 350 iobitridol 76.78g (767.8mg/mL) corresponding to iodine 350mg/mL solution for injection (Singapore)
Medicine in short supply/unavailable:
Section 19A approval holder: Guerbet Australia Pty Ltd ABN: 15 159 798 302
Approval holder phone number: 02 8075 3007
Import and supply approved until:
28 February 2023
Section 19A approved medicine:
ULTRAVIST 300 iopromide 31.17g/50mL (equivalent to 300 mg/1 mL of organically bound iodine) solution for injection (Vietnam)
Medicine in short supply/unavailable:
Section 19A approval holder: Bayer Australia Ltd ABN: 22 000 138 714
Approval holder phone number: 1800 008 757
Import and supply approved until:
29 August 2022
Section 19A approved medicine:
EUROFOLIC folinic acid 50mg/5mL solution for injection (Germany)
Medicine in short supply/unavailable:
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516
Approval holder phone number: 1800 181 060
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
Cidofovir 375mg/5mL injection for IV infusion vial (Heritage)
Medicine in short supply/unavailable:
Section 19A approval holder: Orspec Pharma Pty Ltd ABN: 15 634 980 417
Approval holder phone number: 02 4339 4239
Import and supply approved until:
31 May 2023
Section 19A approved medicine:
OPTIRAY 320 Ioversol 678mg/mL (equivalent to 320 mg of organically bound iodine) sterile solution for injection - 100 mL prefilled syringe (Canada)
Medicine in short supply/unavailable:
Section 19A approval holder: Guerbet Australia Pty Ltd ABN: 15 159 798 302
Import and supply approved until:
31 March 2023
Section 19A approved medicine:
IXIARO Japanese encephalitis vaccine (inactivated, adsorbed) suspension for injection pre-filled syringe
Medicine in short supply/unavailable:
Section 19A approval holder: Seqirus Australia Pty Ltd ABN 66 120 398 067
Approval holder phone number: 1800 008 275
Import and supply approved until:
31 March 2022
Section 19A approved medicine:
(Approval lapsed) Heparin Sodium Injection USP 5000 units/mL solution (McKesson/SKY)
Medicine in short supply/unavailable:
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516
Approval holder phone number: 1800 181 060
Import and supply approved until:
31 August 2022
Section 19A approved medicine:
NOPIL fur Kinder Sirup - sulfamethoxazole and trimethoprim 200 mg/40 mg oral syrup 100 mL bottle
Medicine in short supply/unavailable:
Section 19A approval holder: Orspec Pharma Pty Ltd ABN 15 634 980 417
Approval holder phone number: 02 4339 4239
Import and supply approved until:
31 October 2022
Section 19A approved medicine:
IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial (International presentation)
Medicine in short supply/unavailable:
Section 19A approval holder: Sanofi-Aventis Australia Pty Ltd ABN 31 008 558 807
Approval holder phone number: 1800 818 806