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.
GONAL-f : EPAR - Summary for the public (PDF/61.46 KB)
First published: 31/08/2006
Last updated: 28/09/2010
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
02/08/2018 GONAL-f - EMEA/H/C/000071 - T/0140
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Sex hormones and modulators of the genital system
- 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.