Import and supply approved until:
30 June 2023
Section 19A approved medicine:
Curium Gallium (Ga-67) citrate 37 MBq/ml solution for injection (Curium Netherlands B.V.)
Medicine in short supply/unavailable:
- LANTHEUS GALLIUM(67Ga) citrate 74MBq/mL injection USP multidose vial - ARTG 19144
Section 19A approval holder: Global Medical Solutions Australia ABN: 66 072 147 561
Approval holder phone number:
(02) 9503 8100
Indications of the section 19A approved product
Gallium Citrate Ga 67 Injection, U.S.P. may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.
Import and supply approved until:
31 October 2022
Section 19A approved medicine:
TRULICITY dulaglutide 1.5 mg/0.5 mL solution for injection prefilled pen (Netherlands)
Medicine in short supply/unavailable:
- TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen - AUST R: 217965
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number:
1300 788 261
Indications of the section 19A approved product
Type 2 Diabetes Mellitus - Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes
Import and supply approved until:
30 June 2023
Section 19A approved medicine:
Thallous (TI201) Chloride Injection, 37MBq/mL, solution for injection (Curium)
Medicine in short supply/unavailable:
- LANTHEUS THALLIUM[201Tl] CHLORIDE 74MBq/mL injection multidose vial AUST R: 112603
Section 19A approval holder: Global Medical Solutions Australia Pty Limited ABN: 66 072 147 561
Approval holder phone number:
(02) 9503 8100
Indications of the section 19A approved product
Thallous Chloride Tl 201 Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction.
It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease.
Thallous Chloride Tl 201 Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyperparathyroidism
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
(Approval lapsed [31/07/2022]) Daunorubicin (Zentiva) 20mg powder for IV injection
Medicine in short supply/unavailable:
- Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial
Section 19A approval holder: Link Medical Products Pty Ltd ABN: 73 010 971 516
Approval holder phone number:
1800 181 060
Indications of the section 19A approved product
- Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.
- Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g., cytarabine)
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
(Approval lapsed [31/07/2022]) QLAIRA estradiol valerate/dienogest film coated tablets composite pack in wallet pack (Jenapharm)
Medicine in short supply/unavailable:
- QLAIRA estradiol valerate / dienogest tablets composite pack in wallet pack - ARTG 149319
Section 19A approval holder: Link Medical Products Pty Ltd ABN: 73 010 971 516
Approval holder phone number:
1800 181 060
Indications of the section 19A approved product
Oral contraception. Treatment of heavy menstrual bleeding without an organic cause in women who wish to use oral contraception.
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled pen (Germany)
Medicine in short supply/unavailable:
- ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector AUST R 236039
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number:
1300 788 261
Indications of the section 19A approved product
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.
ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)
ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.
ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled syringe (Germany)
Medicine in short supply/unavailable:
- ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange AUST R 206764
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516
Approval holder phone number:
1800 181 060
Indications of the section 19A approved product
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.
ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)
ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.
ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).
Import and supply approved until:
31 July 2022
Section 19A approved medicine:
(Approval lapsed [31/07/2022]) ORENCIA 125 mg solution for injection in pre-filled pen (Germany)
Medicine in short supply/unavailable:
- ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector AUST R 236039
Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516
Approval holder phone number:
1800 181 060
Indications of the section 19A approved product
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.
ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)
ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.
ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).
Import and supply approved until:
28 February 2023
Section 19A approved medicine:
Ethosuximide Essential Generics 250 mg Capsules (UK)
Medicine in short supply/unavailable:
- ZARONTIN ethosuximide 250mg capsule bottle ARTG: 94175
Section 19A approval holder: Clinect Pty Ltd ABN 76 150 558 473
Approval holder phone number:
1800 899 005
Indications of the section 19A approved product
For the control of petit mal epilepsy
Import and supply approved until:
30 November 2022
Section 19A approved medicine:
Pyridostigmine bromide extended-release tablets 180mg (Rising Pharmaceuticals)
Medicine in short supply/unavailable:
- MESTINON TIMESPAN pyridostigmine bromide 180mg tablet bottle AUST R: 13749
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number:
1300 788 261
Indications of the section 19A approved product
Useful in the treatment of myasthenia gravis
