Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced
|
2 May 2022 |
|
First round evaluation completed |
26 July 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
14 November 2022 |
|
Second round evaluation completed |
16 December 2022 |
|
Delegate’s Overall benefit-risk assessment |
10 February 2023 |
|
Sponsor’s pre-Advisory Committee response |
Not applicable |
|
Advisory Committee meeting |
Not applicable |
|
Registration decision (Outcome) |
21 March 2023 |
|
Completion of administrative activities and registration on ARTG |
6 April 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
171 |
*Statutory timeframe for standard applications is 255 working days
This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Cresol, glacial acetic acid, hydrochloric acid, mannitol, sodium acetate, sodium hydroxide, water for injections
Each dose of 80 microlitres contains 20 micrograms of teriparatide.
The recommended dose of Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen.
For further information refer to the Product Information.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) was approved for the following therapeutic use:
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) 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.
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.
- Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) are to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL EU [European Union]-risk management plan (RMP) (version 3.0, dated 19 June 2020, data lock point 16 July 2018), with Australia specific annex (version 0.3, dated 14 November 2022), included with Submission PM-2021-03753-1-5, and any subsequent revisions, as agreed with the 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 (revision 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- Any changes to which the sponsor has agreed should be included in a revised RMP and ASA. However, irrespective of whether or not they are included in the currently available version of the RMP document, the agreed changes become part of the risk management system.
- For all injectable products the Product Information must be included with the product as a package insert.