Veoza (fezolinetant)
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 8 February 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 31 October 2023 |
Advisory Committee meeting | 30 November and 1 December 2023 |
Registration decision (Outcome) | 22 February 2024 |
Completion of administrative activities and registration on ARTG | 26 February 2024 |
Number of working days from submission dossier acceptance to registration decision* | 206 |
*Statutory timeframe for standard applications is 255 working days
The recommended dose of Veoza is 45 mg once daily.
The benefit and duration of treatment with Veoza should be periodically assessed based on the natural history and course of the vasomotor symptoms (VMS) associated with menopause. No clinical data beyond a treatment period of 12 months are available (see Product Information section 5.1 Pharmacodynamic Properties – Clinical Trials).
A baseline and subsequent periodic evaluation of liver function is recommended (see Product Information section 4.4 Special warnings and precautions for use).
For more 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. The pregnancy database 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.
Veoza (fezolinetant) was approved for the following therapeutic use:
Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
- Veoza (fezolinetant) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Veoza 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 Veoza EU [European Union]-risk management plan (RMP) (version 1.0, dated 3 August 2022, data lock point 21 January 2022), with Australia-specific annex (version 2.0, dated July 2023), included with Submission PM-2022-05510-1-5, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.