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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

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 13/11/2019

Lapse Date: 13/05/2020

Medicine Name: onasemnogene abeparvovec

Therapeutic area: Neurology

Treatment of patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the SMN1 gene

Clinuvel Pharmaceuticals Ltd

Designation/determination: Priority review

Effective Date: 23/10/2019

Lapse Date: 23/04/2020

Medicine Name: afamelanotide

Dosage Form(s): Suspension for intravenous infusion

Therapeutic area: Haematology

For the prevention of phototoxicity in adult patients with erythropoietic protoporphyria

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 22/10/2019

Lapse Date: 22/04/2020

Medicine Name: crizanlizumab

Dosage Form(s): Concentrate solution for Infusion

Therapeutic area: Haematology

For the prevention of vaso-occlusive crises in sickle cell disease patients

Dr Reddy's Laboratories Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 09/10/2019

Lapse Date: 09/04/2020

Medicine Name: trientine hydrochloride

Dosage Form(s): capsule

Therapeutic area: Inherited metabollic disorders

Treatment of Wilson's Disease

AstraZeneca Pty Ltd

Designation/determination: Orphan drug

Effective Date: 25/09/2019

Lapse Date: 25/03/2020

Medicine Name: moxetumomab pasudotox

Dosage Form(s): Powder for injection

Therapeutic area: Haematology

Treatment of hairy cell leukaemia

Abbvie Pty Ltd

Designation/determination: Orphan drug

Effective Date: 25/09/2019

Lapse Date: 25/03/2020

Medicine Name: venetoclax

Dosage Form(s): Film-coated tablet

Therapeutic area: Haematology

Treatment of patients with Acute Myeloid Leukaemia (AML)

Abbvie Pty Ltd

Designation/determination: Provisional approval

Effective Date: 17/09/2019

Lapse Date: 17/03/2020

Medicine Name: venetoclax

Therapeutic area: Haematology

Alexion Pharmaceuticals Australasia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 16/09/2019

Lapse Date: 16/03/2020

Medicine Name: eculizimab (Soliris)

Dosage Form(s): solution for intravenous infusion

Therapeutic area: Neurology

Treatment of patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti aquaporin 4 antibody positive

Roche Products Pty Limited

Designation/determination: Orphan drug

Effective Date: 12/09/2019

Lapse Date: 12/03/2020

Medicine Name: satralizumab

Dosage Form(s): Solution for subcutaneous Injection

Therapeutic area: Haematology

Treatment of patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti aquaporin 4 antibody positive

Recordati Rare Diseases Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 15/08/2019

Lapse Date: 15/02/2020

Medicine Name: chlormethine (as chlormethine hydrochloride)

Dosage Form(s): Topical gel

Therapeutic area: Haematology

For the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL)

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