Indication
Indicated in combination with other chemotherapy medicinal products as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT)
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.
Displaying 1 - 10 of 157
Designation/determination: Orphan drug
Effective Date: 07/01/2021
Lapse Date: 07/07/2021
Medicine Name: thiotepa
Dosage Form(s): Powder for injection
Therapeutic area: Oncogoly
Designation/determination: Provisional approval
Effective Date: 07/01/2021
Lapse Date: 07/07/2021
Medicine Name: human papillomavirus 9-valent vaccine
Therapeutic area: Infectious diseases
Designation/determination: Provisional approval
Effective Date: 07/01/2021
Lapse Date: 07/07/2021
Medicine Name: sotorasib
Therapeutic area: Oncology
Designation/determination: Orphan drug
Effective Date: 21/12/2020
Lapse Date: 21/06/2021
Medicine Name: ruxolitinib (as phosphate)
Dosage Form(s): tablets
Therapeutic area: Immunology
Designation/determination: Priority review
Effective Date: 21/12/2020
Lapse Date: 21/06/2021
Medicine Name: ruxolitinib (as phosphate)
Therapeutic area: Immunology
Designation/determination: Priority review
Effective Date: 04/12/2020
Lapse Date: 04/06/2021
Medicine Name: PSMA-HBEC-CC
Therapeutic area: Oncology
Designation/determination: Priority review
Effective Date: 04/12/2020
Lapse Date: 04/06/2021
Medicine Name: sacituzumab govitecan
Therapeutic area: Oncology
Designation/determination: Provisional approval
Effective Date: 16/11/2020
Lapse Date: 16/05/2021
Medicine Name: Ad26.COV2.S
Therapeutic area: Infectious diseases
Designation/determination: Priority review
Effective Date: 13/11/2020
Lapse Date: 13/05/2021
Medicine Name: dapagliflozin (as propanediol monohydrate)
Designation/determination: Orphan drug
Effective Date: 10/11/2020
Lapse Date: 10/05/2021
Medicine Name: pembrolizumab
Dosage Form(s): Concentrated injection/Powder for Injection
Therapeutic area: Oncology