Nextstellis
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 September 2020 |
| First round evaluation completed | 6 May 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 1 June 2021 |
| Second round evaluation completed | 16 June 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 30 August 2021 |
| Sponsor's pre-Advisory Committee response | 14 September 2021 |
| Advisory Committee meeting | 30 September and 1 October 2021 |
| Registration decision (Outcome) | 10 November 2021 |
| Completion of administrative activities and registration on ARTG | 26 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 200 |
*Statutory timeframe for standard applications is 255 working days
Lactose monohydrate, maize starch, magnesium stearate, hypromellose, hyprolose, purified talc, hydrogenated cottonseed oil, titanium dioxide (for both the active and inactive tablets)
Sodium starch glycollate type A, povidone and iron oxide red (for the active tablet only)
Nextstellis should be started using instructions for starting or switching (under Section 4.2 Dose and method of administration of the Product Information). Women with no current use of hormonal contraception should consider the possibility of pregnancy prior to initiation of this product.
Nextstellis (pink active and white inactive tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days. Once established on Nextstellis, the administration cycle will involve 24 active pink tablets taken consecutively followed by 4 inactive white tablets. This may be across different blister packs. Tablets must be taken every day at about the same time of the day so that the interval between consecutive tablets is the same.
For further information refer to the Product Information.
Nextstellis (estetrol (as monohydrate)/drospirenone) was approved for the following therapeutic use:
Nextstellis is indicated for use by women of reproductive potential to prevent pregnancy.
- Nextstellis (estetrol monohydrate/drospirenone) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Nextstellis 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 Nextstellis European Union (EU)-risk management plan (RMP) (version 0.7, dated 17 March 2021, data lock point 31 October 2019), with Australian specific annex (version 0.2, dated 28 April 2021), included with Submission PM-2020-04185-1-5, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of RMP 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.