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  • Ovaleap®▼(follitropin alfa)  from Teva


    (follitropin alfa)

Prescribing Ovaleap®

Ovaleap® (follitropin alfa) : 300IU/0.5mL, 450IU/0.75mL and 900IU/1.5mL.1

Therapeutic indications

Ovaleap® (follitropin alfa) is indicated:

In adult women:

  • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate
  • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer
  • Ovaleap® in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2IU/L1

In adult men:

  • Ovaleap® is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy1

About Ovaleap®

Each mL of the solution contains 600IU (equivalent to 44mcg) follitropin alfa. Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR) via recombinant DNA technology.1

Each cartridge contains either 300IU, 450IU or 900IU of Ovaleap® for injection.1

Ovaleap® is a clear, colourless solution intended for subcutaneous administration with a pH of 6.8-7.2.1

As the Ovaleap® multi-dose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multi-dose presentation.

The Ovaleap® cartridge is designed for use in conjunction with the Ovaleap® Pen® only, available separately.1

Marketing Authorisation

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Marketing Authorisation Number(s)

  • EU/1/13/871/001-003

Resources for Ovaleap®

You can ask a question, request to see a representative from Teva, or report a side effect.

Ask a Question Request a Rep Report Suspected Side Effect
Medicine supporting documentation for Ovaleap®
  • Summary of Product Characteristics - Ovaleap® 300IU/0.5ml_450iu/0.75ml_900IU/1.5ml
    View Document >
  • Patient Information Leaflet - Ovaleap® 300IU/0.5ml_450iu/0.75ml_900IU/1.5ml
    View Document >
  • Material Safety Data Sheet
    View Document >

1 Ovaleap® (follitropin alfa) Summary of Product Characteristics.

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