EPARs human use - GONAL-f//Recombinant human follicle stimulating hormone

FICHA FARMACOLÓGICA de Recombinant human follicle stimulating hormone . Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. AGOSTO 09, 2009.-

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EPARs for authorised medicinal products for human use - GONAL-f

Active Substance
Recombinant human follicle stimulating hormone
International Nonproprietary Name or Common Name
Follitropin alfa
Pharmaco-therapeutic Group
Gonadotropins
ATC Code
GO3GA05

Therapeutic Indication:
(i) Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.

(ii) 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).

(iii) 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.

(iv) 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.

Date of issue of Marketing Authorisation valid throughout the European Union
20 October 1995

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use