Ovaleap (follitropin alfa)
- Region
- 🇪🇺 EU
- Active substance
- follitropin alfa
- Company
- Theramex Ireland Limited
- Status
- Authorised
- Therapeutic area
- Anovulation
- EU approval
- Fri 27 Sep 2013
- Designations
- Biosimilar
- Application
- EMEA/H/C/002608
- ATC
- G03GA05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 GONAL-f Authorised · Merck Europe B.V.
- 🇪🇺 Bemfola Authorised · Gedeon Richter Plc.
- 🇪🇺 Elonva Authorised · Organon N.V.
- 🇪🇺 Pergoveris Authorised · Merck Europe B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.