Ovaleap
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 January 2020 |
| First round evaluation completed | 30 June 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 4 September 2020 |
| Second round evaluation completed | 1 October 2020 |
| Delegate's overall benefit-risk assessment | 23 January 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 9 March 2021 |
| Completion of administrative activities and registration on ARTG | 10 March 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 187 |
*Statutory timeframe for standard applications is 255 working days
Treatment with Ovaleap should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
The injection site should be alternated daily to prevent lipoatrophy. Self-administration of Ovaleap should only be performed by patients who are well motivated, adequately trained and who have access to expert advice. Ovaleap cartridge should only be administered using the Ovaleap Pen, which is separately available.
The recommended dosage of Ovaleap depends on multiple factors, including the condition being treated and the individual patient's response to treatment.
For further information refer to the Product Information.
Ovaleap (follitropin alfa) was approved for the following therapeutic use:
- The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.
- For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.
- Ovaleap is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.
- Post marketing reports are to be prepared annually until the period covered by such reports is not less than three years from the date of the approval letter. No fewer than three annual reports are to be prepared. The reports are to at least meet the requirements for periodic safety update reports (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. Reports are to be submitted to the TGA only when requested in writing by the TGA. When requested, reports must be provided to the TGA within ten (10) calendar days. Preparation of the report must be completed within ninety calendar days of the data lock point for that report. An annual report may be made up of two PSURs each covering six months. Note that submission of a PSUR does not constitute an application to vary the registration.
- Laboratory testing and compliance with Certified Product Details
- All batches of:
- Ovaleap 450 IU/0.75 mL follitropin alfa (rch) solution for injection- cartridge;
- Ovaleap 900 IU/1.5 mL follitropin alfa (rch) solution for injection- cartridge;
- Ovaleap 300 IU/0.5 mL follitropin alfa (rch) solution for injection- cartridge
supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (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.
- All batches of:
- 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.
- For all injectable products the Product Information must be included with the product as a package insert