GONAL-f (follitropin alfa)
- Region
- 🇪🇺 EU
- Active substance
- follitropin alfa
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
- EU approval
- Fri 20 Oct 1995
- Application
- EMEA/H/C/000071
- ATC
- G03GA05
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Bemfola Authorised · Gedeon Richter Plc.
- 🇪🇺 Elonva Authorised · Organon N.V.
- 🇪🇺 Pergoveris Authorised · Merck Europe B.V.
- 🇪🇺 Ovaleap Authorised · Theramex Ireland Limited
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