Import and supply approved until:
28 February 2022
Section 19A approved medicine:
RoActemra tocilizumab 80mg/4mL concentrate for solution for infusion (Roche Germany)
Medicine in short supply/unavailable:
- ACTEMRA tocilizumab (rch) 80 mg/4 mL injection concentrated vial - AUST R 149403
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
Rheumatoid Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.
In the two groups of patients above, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.
Polyarticular Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). It can be given alone or in combination with MTX.
Systemic Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Cytokine Release Syndrome (CRS):
Tocilizumab is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Import and supply approved until:
30 November 2021
Section 19A approved medicine:
DUPIXENT dupilumab 200mg/1.14mL solution for injection in pre-filled syringe with needle shield (USA)
Medicine in short supply/unavailable:
- DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled syringe with needle shield - AUST R 302463
Section 19A approval holder: Sanofi - Aventis Australia Pty Ltd ABN 31 008 558 807
Approval holder phone number:
1800 818 806
Indications of the section 19A approved product
Dupixent is indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.
Dupixent is indicated as add on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO).
Dupixent is indicated as maintenance therapy for oral corticosteroid dependent asthma.
Import and supply approved until:
30 November 2021
Section 19A approved medicine:
Dosulepin capsules 25 mg (Strides Pharma UK Ltd)
Medicine in short supply/unavailable:
- DOSULEPIN MYLAN 25 dosulepin (dothiepin) hydrochloride 25 mg hard capsule blister pack - AUST R: 289783
- DOTHEP 25 dosulepin (dothiepin) hydrochloride 25mg capsule blister pack - AUST R 34419
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
For the treatment of major depression.
Import and supply approved until:
30 November 2021
Section 19A approved medicine:
Nitrofurantoin 50mg capsules, USP (Macrocrystals) (Sun Pharma)
Medicine in short supply/unavailable:
- APO-NITROFURANTOIN nitrofurantoin 50 mg capsule bottle pack - AUST R 299383
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
- Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens
- Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis
Import and supply approved until:
28 February 2022
Section 19A approved medicine:
RoActemra tocilizumab 400 mg/ 20mL concentrate for solution for infusion (Roche Germany)
Medicine in short supply/unavailable:
- ACTEMRA tocilizumab (rch) 400 mg/20 mL injection concentrated vial - AUST R 149402
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
Rheumatoid Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.
In the two groups of patients above, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.
Polyarticular Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). It can be given alone or in combination with MTX.
Systemic Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Cytokine Release Syndrome (CRS):
Tocilizumab is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Import and supply approved until:
28 February 2022
Section 19A approved medicine:
RoActemra tocilizumab 200 mg/ 10mL concentrate for solution for infusion (Roche Germany)
Medicine in short supply/unavailable:
- ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial - AUST R 149404
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
Rheumatoid Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.
Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.
In the two groups of patients above, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.
Polyarticular Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). It can be given alone or in combination with MTX.
Systemic Juvenile Idiopathic Arthritis:
Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Cytokine Release Syndrome (CRS):
Tocilizumab is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Import and supply approved until:
30 June 2021
Section 19A approved medicine:
(Approval lapsed) Sertraline 50mg film-coated tablets (Ranbaxy UK)
Medicine in short supply/unavailable:
- APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack - ARTG 213177
- SETRONA sertraline (as hydrochloride) 50 mg tablet blister pack - ARTG 116623
- SERTRALINE-STR sertraline (as hydrochloride) 50 mg tablet blister pack - ARTG 107067
- SERTRALINE SANDOZ sertraline 50mg (as hydrochloride) film coated tablet blister pack - ARTG 98697
- SERTRALINE GENERICHEALTH sertraline 50mg (as hydrochloride) tablet blister pack - ARTG 124855
Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066
Approval holder phone number:
0427 902 599
Indications of the section 19A approved product
Indicated for the treatment of children (aged 6 years of age and older) and adolescents with obsessive compulsive disorder (OCD).
Indicated in adults for the treatment of:
- Major depression
- Obsessive compulsive disorder (OCD)
- Panic disorder
- Social phobia (social anxiety disorder) and the prevention of its relapse
- Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
Import and supply approved until:
30 June 2021
Section 19A approved medicine:
(Approval lapsed) Sertraline 100mg film-coated tablets (Ranbaxy UK)
Medicine in short supply/unavailable:
- APO-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack - ARTG 213180
- ELEVA 100 sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 95583
- SERTRALINE SANDOZ sertraline 100mg (as hydrochloride) film coated tablet blister pack - ARTG 98698
- SERTRA 100 sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 213181
- SETRONA sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 116636
- ZOLOFT sertraline (as hydrochloride) 100 mg tablet blister pack - ARTG 321602
- SERTRALINE GENERICHEALTH sertraline 100mg (as hydrochloride) tablet blister pack - ARTG 124856
Section 19A approval holder: Barwon Pharma Pty Ltd ABN 93 169 715 066
Approval holder phone number:
0427 902 599
Indications of the section 19A approved product
Indicated for the treatment of children (aged 6 years of age and older) and adolescents with obsessive compulsive disorder (OCD).
Indicated in adults for the treatment of:
- Major depression
- Obsessive compulsive disorder (OCD)
- Panic disorder
- Social phobia (social anxiety disorder) and the prevention of its relapse
- Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
Import and supply approved until:
31 January 2022
Section 19A approved medicine:
BCG Culture SSI 30mg/vial (AJ Vaccines)
Medicine in short supply/unavailable:
- ONCOTICE BCG 5 hundred million CFU powder for injection vial - ARTG 59912
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
Treatment of primary or recurrent carcinoma in situ (CIS) of the urinary bladder.
Intravesicular 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]).
Intravesicular BCG is only recommended for stage TA grade 1 tumours, when there is judged to be a high risk of tumour recurrence.
Import and supply approved until:
31 March 2021
Section 19A approved medicine:
(Approval lapsed) Carbimazole 5mg tablets (Morningside Healthcare)
Medicine in short supply/unavailable:
- Carbimazole Neo-Mercazole 5mg tablets bottle of 100 - ARTG 194296
Section 19A approval holder: Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Approval holder phone number:
1301 788 261
Indications of the section 19A approved product
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.
