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Prescription medicines determination and designation notices

20 September 2021

What is determination?

Determination is a formal process that allows the TGA to make a decision regarding whether a medicine is eligible for registration via the provisional approval pathway or the priority review pathway.

The sponsor of the medicine must submit an application for determination to allow the TGA to make a decision on whether the medicine meets the eligibility criteria. These eligibility criteria are designed to ensure that only products providing the most benefit to patients are eligible. Eligibility criteria for provisional determination and priority review determination are published on our website.

Designation is similar to determination, but in this case, it allows the TGA to make a decision regarding whether a medicine is eligible for Orphan drug status. More information on our orphan drug program is available at the Orphan drug program reforms webpage.

Amendments to the Therapeutic Goods Regulations 1990 which came into effect on 1 July 2017 changed the eligibility criteria for orphan drug designation. A transition period applies to orphan drugs designated under the previous orphan drug program. A list of orphan drugs designated under the previous program is available.

A determination or designation does not mean that the medicine has been approved and registered in the Australian Register of Therapeutic Goods (ARTG).

To register a medicine after obtaining a designation or determination, the sponsor must lodge an application for registration. These applications are subject to a rigorous evaluation process resulting in a TGA decision on whether the medicine should be registered on the ARTG. Details of registered products approved for supply in Australia can be obtained by searching the ARTG

Orphan designations, priority review and provisional determinations remain in force for a period of 6 months from the initial effective date.

Provisional determinations and orphan drug designations may be extended for a further six months on application by the sponsor. We will grant one extension if all eligibility criteria for the relevant extension are met. A priority review determination cannot be extended.

Details of prescription medicines that have an approved provisional determination, priority review determination or orphan drug designation are listed below.

Approved determinations and designations for prescription medicines

Displaying 1 - 50 of 51

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 08/09/2021

Lapse Date: 08/03/2022

Medicine Name: pembrolizumab

Therapeutic area: Oncology

Keytruda (pembrolizumab), in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer

ViiV Healthcare Pty Ltd

Designation/determination: Priority review

Effective Date: 06/09/2021

Lapse Date: 06/03/2022

Medicine Name: cabotegravir (as sodium) and cabotegravir

Therapeutic area: Infectious diseases

Cabotegravir prolonged release suspension for injection: Pre Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg. Cabotegravir oral film-coated tablet: Short term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg. Cabotegravir tablets may be used as: oral lead-in to assess tolerability of cabotegravir prior to administration of cabotegravir injection. oral PrEP in individuals who will miss planned dosing with cabotegravir injection

Adjutor Healthcare Pty Ltd

Designation/determination: Priority review

Effective Date: 30/08/2021

Lapse Date: 02/03/2022

Medicine Name: tebentafusp

Therapeutic area: Oncology

For the for the treatment of unresectable or metastatic uveal melanoma.

Sanofi-Aventis Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 24/08/2021

Lapse Date: 24/02/2022

Medicine Name: cemiplimab

Therapeutic area: Oncology

For the treatment of patients with recurrent or metastatic cervical cancer who have progressed on or after chemotherapy.

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 23/04/2021

Lapse Date: 23/10/2021

Medicine Name: pembrolizumab

Therapeutic area: Oncology

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Eisai Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 23/04/2021

Lapse Date: 23/10/2021

Medicine Name: lenvatinib (as mesilate)

Therapeutic area: Oncology

LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 21/12/2020

Lapse Date: 21/06/2021

Medicine Name: ruxolitinib (as phosphate)

Therapeutic area: Immunology

Jakavi is indicated for the treatment of patients with Graft versus Host Disease (GvHD) 12 years and older who have inadequate response to corticosteroids or other systemic therapies

Telix Pharmaceuticals (ANZ) Pty Ltd

Designation/determination: Priority review

Effective Date: 04/12/2020

Lapse Date: 04/06/2021

Medicine Name: PSMA-HBEC-CC

Therapeutic area: Oncology

GA-PSMA-11 injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging to evaluate men diagnosed with prostate cancer

Adjutor Healthcare Pty Ltd

Designation/determination: Priority review

Effective Date: 04/12/2020

Lapse Date: 04/06/2021

Medicine Name: sacituzumab govitecan

Therapeutic area: Oncology

For the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies

AstraZeneca Pty Ltd

Designation/determination: Priority review

Effective Date: 13/11/2020

Lapse Date: 13/05/2021

Medicine Name: dapagliflozin (as propanediol monohydrate)

Forxiga is Indicated in adults for the treatment of chronic kidney disease

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 10/11/2020

Lapse Date: 10/05/2021

Medicine Name: pembrolizumab

Therapeutic area: Oncology

Pembrolizumab, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus and gastroesophageal junction

ORSPEC Pharma Pty Ltd

Designation/determination: Priority review

Effective Date: 09/11/2020

Lapse Date: 09/05/2021

Medicine Name: amifampridine

Therapeutic area: Neurology

RUZURGI is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above.

Kadmon Oceania Pty Ltd

Designation/determination: Priority review

Effective Date: 15/09/2020

Lapse Date: 15/03/2021

Medicine Name: belumosudil

Therapeutic area: Oncology

Treatment of patients 12 years and older with chronic Graft Versus Host Disease (GVHD) after failure of at least one prior line of systemic therapy

AstraZeneca Pty Ltd

Designation/determination: Priority review

Effective Date: 13/08/2020

Lapse Date: 13/02/2021

Medicine Name: osimertinib [as mesilate]

Therapeutic area: Oncology

For the adjuvant treatment after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 20/07/2020

Lapse Date: 20/01/2021

Medicine Name: nivolumab

Therapeutic area: Oncology

Opdivo in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 20/07/2020

Lapse Date: 20/01/2021

Medicine Name: ipilimumab

Therapeutic area: Oncology

Yervoy in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma

Kyowa Kirin Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 16/07/2020

Lapse Date: 16/01/2021

Medicine Name: burosumab

Therapeutic area: Endocrinology

for the treatment of X-linked hypophosphataemia in adult and paediatric patients 1 year of age or older

Pierre Fabre Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 10/07/2020

Lapse Date: 10/01/2021

Medicine Name: encorafenib

Dosage Form(s): Hard capsule

Therapeutic area: Oncology

For the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation as detected by a validated test, who have received prior systemic therapy

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 30/06/2020

Lapse Date: 30/12/2020

Medicine Name: risdiplam

Therapeutic area: Neurology

For the treatment of 5q Spinal Muscular Atrophy (SMA)

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 18/06/2020

Lapse Date: 18/12/2020

Medicine Name: pembrolizumab

Therapeutic area: Oncology

As first-line treatment of patients with unresectable or metastatic mirosatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancer

Merck Healthcare Pty Ltd

Designation/determination: Priority Review

Effective Date: 24/04/2020

Lapse Date: 24/10/2020

Medicine Name: avelumab

Therapeutic area: Oncology

For the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy

Alphapharm Pty Ltd

Designation/determination: Priority review

Effective Date: 21/01/2020

Lapse Date: 21/07/2020

Medicine Name: rifampicin

Therapeutic area: Infectious diseases

For the treatment of patients with Buruli ulcer. Rifampicin is usually recommended to be used in combination with another antibiotic for the treatment of Buruli ulcer

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 10/01/2020

Lapse Date: 10/07/2020

Medicine Name: atezolizumab

Therapeutic area: Oncology

atezolizumab in combinatinon with bevacizumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

AA-Med Pty Ltd

Designation/determination: Priority review

Effective Date: 08/01/2020

Lapse Date: 08/07/2020

Medicine Name: tucatinib

Indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 18/12/2019

Lapse Date: 18/06/2020

Medicine Name: cannabidiol

Therapeutic area: Neurology

Indicated for use as adjunctive therapy of seizures associated with Dravet syndrome (DS) for patients 2 years of age and older

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 18/12/2019

Lapse Date: 18/06/2020

Medicine Name: cannabidiol

Therapeutic area: Neurology

Indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) for patients 2 years of age and older

Tudorrose Consulting Pty Ltd

Designation/determination: Priority review

Effective Date: 04/12/2019

Lapse Date: 04/06/2020

Medicine Name: ripretinib

Therapeutic area: Oncology

Treatment of patients with advanced gastrointestinal stromal tumours (GIST), who have received prior treatment with imatinib, sumitinib and regorafenib.

Clinuvel Pharmaceuticals Ltd

Designation/determination: Priority review

Effective Date: 23/10/2019

Lapse Date: 23/04/2020

Medicine Name: afamelanotide

Therapeutic area: Haematology

For the prevention of phototoxicity in adult patients with erythropoietic protoporphyria

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 24/06/2019

Lapse Date: 24/12/2019

Medicine Name: dinutuximab beta

Therapeutic area: Oncology

Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed or refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interIeukin-2 (IL-2).

Astellas Pharma Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 06/06/2019

Lapse Date: 06/12/2019

Medicine Name: gilteritinib (as fumarate)

Dosage Form(s): Film-coated tablet

Therapeutic area: Haematology

gilteritinib (as fumarate) is indicated for the treatment of adult patients who have relasped or refactory acute myeloid leukemia (AML) with a FLT3 mutation.

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 05/03/2019

Lapse Date: 05/09/2019

Medicine Name: trastuzumab emtansine

Trastuzumab emtansine, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included HER2-targeted therapy.

Seqirus Pty Ltd

Designation/determination: Priority review

Effective Date: 23/01/2019

Lapse Date: 23/07/2019

Medicine Name: Inactivated quadrivalent influenza vaccine

Active immunisation against influenza in the elderly 65 years and older.

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 21/01/2019

Lapse Date: 21/07/2019

Medicine Name: polatuzumab vedotin

Therapeutic area: Haematology

Polatuzumab vedotin in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant.

DBV Technologies Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 29/10/2018

Lapse Date: 29/04/2019

Medicine Name: arachis hypogaea seed allergen extract

Therapeutic area: Allergen

For the treatment of peanut allergy in children aged 4-11 years

AstraZeneca Pty Ltd

Designation/determination: Priority review

Effective Date: 27/09/2018

Lapse Date: 27/03/2019

Medicine Name: olaparib

Therapeutic area: Oncology

For the maintenance treatment of patients with newly diagnosed BRCA-mutated advanced ovarian cancer.

JACE Pharma Pty Ltd

Designation/determination: Priority review

Effective Date: 30/08/2018

Lapse Date: 02/03/2019

Medicine Name: cenegermin (recombinant human nerve growth factor)

Therapeutic area: Ophthalmology

For the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 01/08/2018

Lapse Date: 01/02/2019

Medicine Name: pembrolizumab

Therapeutic area: Oncology

Pembrolizumab, in combination with carboplatin and either paclitaxel or nanoparticle albumin-bound paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 21/06/2018

Lapse Date: 21/12/2018

Medicine Name: eltrombopag olamine

Dosage Form(s): Powder for oral suspension & Tablet, film-coated

Therapeutic area: Haematology

Eltrombopag olamine in combination with standard immunosuppressive therapy (IST) for the first-line treatment of patients 2 years and older with severe aplastic anaemia (SAA).

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 23/05/2018

Lapse Date: 23/11/2018

Medicine Name: pembrolizumab

Pembrolizumab in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations.

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 22/03/2018

Lapse Date: 22/09/2018

Medicine Name: emicizumab

Emicizumab is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 15/03/2018

Lapse Date: 15/09/2018

Medicine Name: pembrolizumab

Indicated for the adjuvant treatment of melanoma patients with lymph node involvement who have undergone complete resection.

Shire Australia Pty Limited

Designation/determination: Priority review

Effective Date: 21/02/2018

Lapse Date: 21/08/2018

Medicine Name: lanadelumab

For the routine prevention of angioedema attacks and control of symptoms of hereditary angioedema (HAE) in adolescents and adults

Janssen-Cilag Pty Ltd

Designation/determination: Priority review

Effective Date: 17/01/2018

Lapse Date: 18/07/2018

Registration date: 05/07/2018

Medicine Name: apalutamide

Dosage Form(s): Tablet

For the treatment of patients with castration-resistant prostate cancer at risk of developing metastases

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 13/12/2017

Lapse Date: 13/06/2018

Registration date: 08/06/2018

Medicine Name: trametinib

Trametinib, in combination with dabrafenib, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 13/12/2017

Lapse Date: 13/06/2018

Registration date: 08/06/2018

Medicine Name: dabrafenib

Dabrafenib, in combination with trametinib, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

BioMarin Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 30/11/2017

Lapse Date: 30/05/2018

Registration date: 28/08/2018

Medicine Name: cerliponase alfa

For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

AstraZeneca Pty Ltd

Designation/determination: Priority Review

Effective Date: 24/11/2017

Lapse Date: 24/05/2018

Registration date: 05/07/2018

Medicine Name: osimertinib

Dosage Form(s): Tablet

For the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 10/11/2017

Lapse Date: 10/05/2018

Registration date: 09/07/2018

Medicine Name: nivolumab

Nivolumab in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor risk advanced renal cell carcinoma (RCC)

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority Review

Effective Date: 28/09/2017

Lapse Date: 28/03/2018

Registration date: 24/04/2018

Medicine Name: nivolumab

For the adjuvant treatment of Stage III/IV melanoma in patients who have undergone complete resection.

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 29/08/2017

Lapse Date: 28/02/2018

Registration date: 23/02/2018

Medicine Name: emicizumab

For routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with haemophilia A (congenital factor Vlll deficiency) with factor Vlll inhibitors. HEMLIBRA can be used in all age groups.

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