Follitropin Alfa
Gonadotropins
Sold as Bemfola · Ovaleap · GONAL-f · PERGOVERIS · GONAL-F PEN
- Drug class
- Gonadotropins
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 33
Overview
Follitropin Alfa is an active pharmaceutical ingredient in the Gonadotropins group (G03GA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 23 | May 22, 2026 |
| CA Canada | Health Canada | 6 | May 27, 2026 |
| EU European Union | EMA | 4 | March 25, 2026 |
GBUnited Kingdom· MHRA
23 products
Uses
In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene 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.
• GONAL-f in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men • GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
How to take
CACanada· Health Canada
6 products
Uses
GONAL-f® (Follitropin alfa for Injection) is indicated for: • GONAL-f® is indicated for the stimulation of multiple follicular development in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization.
To complete follicular maturation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) is given. • GONAL-f® is also indicated for the stimulation of follicular development in patients with hypothalamic-pituitary dysfunction who present either oligomenorrhoea or amenorrhoea (WHO Group II).
To complete follicular maturation and effect ovulation, hCG is given. 1 Pediatrics (< 18 years) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
EUEuropean Union· EMA
4 products
Uses
In adult women 3 • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene 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.
• Follitropin alfa in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. 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 gonadotropin (hCG) therapy.
Sources & citations
- [1]MHRA (UK) · PLGB116480265 · revised October 17, 2025
- [2]Health Canada (DPD) · 02270382 · revised April 16, 2026
- [3]European Medicines Agency · EMEA/H/C/002615 · revised March 25, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.