This is a summary of the European public assessment report (EPAR) for GONAL-f. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for GONAL-f.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
G03GA05
ATC Item
follitropin alfa
Pharmacotherapeutic Group
Sex hormones and modulators of the genital system
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| follitropin alfa | N/A | 重组人促卵泡激素 |
EMA Name
GONAL-f
Medicine Name
GONAL-f
Aliases
N/ANo risk management plan link.
