In adult women

• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.

• Stimulation of multi-follicular 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 to stimulate 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 stimulating spermatogenesis in men with congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.

• hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• tumours of the hypothalamus or pituitary gland
• ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
• gynaecological haemorrhages of unknown aetiology
• ovarian, uterine or mammary carcinoma

GONAL-f must not be used when an effective response cannot be obtained, such as:

• primary ovarian failure
• malformations of sexual organs incompatible with pregnancy
• fibroid tumours of the uterus incompatible with pregnancy
• primary testicular insufficiency