GONAL-f

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follitropin alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/08/2018

Authorisation details

Product details
Name
GONAL-f
Agency product number
EMEA/H/C/000071
Active substance
follitropin alfa
International non-proprietary name (INN) or common name
follitropin alfa
Therapeutic area (MeSH)
  • Anovulation
  • Reproductive Techniques, Assisted
  • Infertility, Female
  • Hypogonadism
Anatomical therapeutic chemical (ATC) code
G03GA05
Publication details
Marketing-authorisation holder
Merck Europe B.V.
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
20/10/1995
Contact address
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

02/08/2018 GONAL-f - EMEA/H/C/000071 - T/0140

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

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.

Assessment history

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