Bemfola (follitropin alfa)
- Region
- 🇪🇺 EU
- Active substance
- follitropin alfa
- Company
- Gedeon Richter Plc.
- Status
- Authorised
- Therapeutic area
- Anovulation
- CHMP opinion
- Wed 22 Jan 2014
- EU approval
- Wed 26 Mar 2014
- Designations
- Biosimilar
- Application
- EMEA/H/C/002615
- ATC
- G03GA05
- Official record
- www.ema.europa.eu
Indication
In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa 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: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 GONAL-f Authorised · Merck Europe B.V.
- 🇪🇺 Elonva Authorised · Organon N.V.
- 🇪🇺 Pergoveris Authorised · Merck Europe B.V.
- 🇪🇺 Ovaleap Authorised · Theramex Ireland Limited
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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.