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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 - 10 of 196

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

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Orphan drug

Effective Date: 08/09/2021

Lapse Date: 08/03/2022

Medicine Name: pembrolizumab

Dosage Form(s): Powder for injection

Therapeutic area: Oncology

For the treatment of cervical cancer

Dr Reddy's Laboratories Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 08/09/2021

Lapse Date: 08/03/2022

Medicine Name: carboprost trometamol

Dosage Form(s): Solution for injection

Therapeutic area: Obstetrics and Gynaecology

For the treatment of postpartum haemorrhage due to uterine atony following failure of conventional treatments.

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.

Adjutor Healthcare Pty Ltd

Designation/determination: Orphan drug

Effective Date: 30/08/2021

Lapse Date: 02/03/2022

Medicine Name: tebentafusp

Dosage Form(s): concentrated solution for infusion

Therapeutic area: Oncology

For the treatment of uveal melanoma

Amicus Therapeutics Pty Ltd

Designation/determination: Orphan drug

Effective Date: 27/08/2021

Lapse Date: 27/02/2022

Medicine Name: migalastat

Dosage Form(s): Hard capsule

Therapeutic area: Inherited metabolic disorders

Indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.

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.

Roche Products Pty Limited

Designation/determination: Provisional approval

Effective Date: 20/08/2021

Lapse Date: 20/02/2022

Medicine Name: casirivimab and imdevimab

Therapeutic area: Infectious diseases

For treatment of confirmed COVID-19 in patients aged 12 years and older and weighing at least 40 kg that do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. For the prevention of COVID-19 in individuals aged 12 years and older and weighing at least 40 kg who meet one or more of the following criteria: have been exposed or are at high risk of exposure to SARS-CoV-2 have a medical condition making them unlikely to respond to or be protected by vaccination.

Celltrion Healthcare Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 20/08/2021

Lapse Date: 20/02/2022

Medicine Name: regdanvimab

Therapeutic area: Infectious diseases

For treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult patients who are confirmed to be infected with SARS-CoV-2

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