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Prescription medicines determination and designation notices

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

ANSTO t/a ANSTO Health

Designation/determination: Orphan Drug

Effective Date: 16/01/2019

Lapse Date: 17/07/2019

Medicine Name: lutetium-177 non-carrier added supplied as 177LuCl3

For the treatment of neuroendocrine tumours

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Designation/determination: Orphan drug

Effective Date: 20/12/2018

Lapse Date: 20/06/2019

Medicine Name: methotrexate

Dosage Form(s): Oral liquid, solution

For the treatment of Acute Lymphoblastic Leukaemia (ALL)

Vertex Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 05/12/2018

Lapse Date: 05/06/2019

Medicine Name: tezacaftor/ivacaftor

Dosage Form(s): Tablet, film-coated

For the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

Boehringer Ingelheim Pty Ltd

Designation/determination: Orphan drug

Effective Date: 19/11/2018

Lapse Date: 19/05/2019

Medicine Name: nintedanib

Dosage Form(s): capsule, soft

Nintedanib is indicated for the treatment of Systemic Sclerosis (SSc)

Therapeutic area: Immunology

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

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

Therapeutic area: Allergen

Abbvie Pty Ltd

Designation/determination: Provisional approval

Effective Date: 29/10/2018

Lapse Date: 29/04/2019

Medicine Name: venetoclax

Therapeutic area: Haematology

Abbvie Pty Ltd

Designation/determination: Orphan drug

Effective Date: 29/10/2018

Lapse Date: 29/04/2019

Medicine Name: venetoclax

Dosage Form(s): Tablet, film-coated

Venetoclax is indicated for the treatment of patients with acute myeloid leukaemia (AML)

Therapeutic area: Haematology

Alexion Pharmaceuticals Australasia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 11/10/2018

Lapse Date: 11/04/2019

Medicine Name: ravulizumab

Dosage Form(s): Injection, intravenous infusion

For the treatment of paroxysmal nocturnal haemoglobinuria (PNH)

Therapeutic area: Haematology

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 05/10/2018

Lapse Date: 05/04/2019

Medicine Name: ranibizumab

Dosage Form(s): Injection solution

For the treatment of preterm infants with retinopathy of prematurity (ROP)

Therapeutic area: Ophthalmology

Roche Products Pty Limited

Designation/determination: Orphan drug

Effective Date: 27/09/2018

Lapse Date: 27/03/2019

Medicine Name: atezolizumab

Dosage Form(s): Tablet

Treatment of small cell lung cancer

Therapeutic area: Oncology

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