Anpheros Search · Treatment

Follitropin alfa

Also known as: GONAL-f · Ovaleap · Bemfola

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In short

In the European Union, follitropin alfa is indicated for anovulation, including polycystic ovarian disease, in women who have not responded to clomiphene citrate, and for stimulating multifollicular development in patients undergoing assisted reproductive technologies such as in-vitro fertilisation, gamete intra-fallopian transfer, and zygote intra-fallopian transfer. In the European Union, it is also indicated in association with a luteinising hormone preparation for stimulating follicular development in women with severe luteinising hormone and follicle-stimulating hormone deficiency, and for stimulating spermatogenesis in men with congenital or acquired hypogonadotrophic hypogonadism alongside human chorionic gonadotrophin therapy. In the United States, follitropin alfa is indicated for the induction of ovulation and pregnancy in oligo-anovulatory infertile women with functional infertility, the development of multiple follicles in ovulatory infertile women during assisted reproductive technology cycles, and the induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism. Follitropin alfa is listed by the cited source as having an approved use for female infertility.

From: Source: European Medicines Agency (EMA), GONAL-f — EPAR, 09/01/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
386938 follitropin alfa
EMA
EMEA/H/C/000071, EMEA/H/C/002608, EMEA/H/C/002615

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) GONAL-f

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). GONAL-f 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. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.

Source: European Medicines Agency (EMA), GONAL-f — EPAR, 09/01/2025. © European Medicines Agency.

Document date: 09/01/2025 · Official document →

FDA (USA) Gonal-f

1 INDICATIONS AND USAGE GONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. ( 1.1 ) Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles. ( 1.2 ) Men: Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure. ( 1.3 ) 1.1 Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. 1.2 Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle. 1.3 Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure.

Data provided by the U.S. Food and Drug Administration.

Document date: 20250902 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Follitropin alfa approved for in the European Union?

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). GONAL-f 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. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy. (Source: European Medicines Agency (EMA), GONAL-f — EPAR, 09/01/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), GONAL-f — EPAR, 09/01/2025. © European Medicines Agency.

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