Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 15 August 2018

Indication(s)

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 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
• 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.

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More information

Category Value
Agency product number EMEA/H/C/000071
Orphan designation No
Date First Approved 20-10-1995
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Merck Europe B.V.