Terrosa
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 3 January 2020 |
| First round evaluation completed | 10 July 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 10 August 2020 |
| Second round evaluation completed | 28 August 2020 |
| Delegate's overall benefit-risk assessment | 12 November 2020 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 24 November 2020 |
| Completion of administrative activities and registration on ARTG | 1 December 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 195 |
*Statutory timeframe for standard applications is 255 working days
The recommended dose of Terrosa is 20 µg administered once daily by subcutaneous injection in the thigh or abdomen.
Terrosa should be prescribed to patients with a full explanation and their informed consent on the lifetime duration of 24 months treatment.
For further information refer to the Product Information.
Terrosa (teriparatide) was approved for the following therapeutic use:
Terrosa is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.
Terrosa is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture
- The Terrosa European Union (EU)-Risk Management Plan (RMP) (version 2.1, dated 18 June 2020; data lock point (DLP) 10 June 2020), with Australian Specific Annex (version 2.0, dated 24 June 2020), included with submission PM-2019-05333-1-5, and any subsequent revisions, as agreed with the Therapeutic Goods Administration (TGA) will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Terrosa supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the CPD.
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
- Certified Product Details
- The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change. The CPD should be emailed to Biochemistry.Testing@health.gov.au as a single PDF document.
- For all injectable products the Product Information must be included with the product as package insert.