This is a summary of the European public assessment report (EPAR) for Ovaleap. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ovaleap. For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication **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 < 1.2 IU/L. **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) therapy.
Therapeutic Area (MeSH)
N/AATC Code
G03GA05
ATC Item
follitropin alfa
Pharmacotherapeutic Group
Sex hormones and modulators of the genital system
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| follitropin alfa | N/A | 重组人促卵泡激素 |
EMA Name
Ovaleap
Medicine Name
Ovaleap
Aliases
N/ANo risk management plan link.
