GONAL-f

follitropin alfa

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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.

What is GONAL-f?

GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.

What is GONAL-f used for?

GONAL-f is used to treat the following groups:

  • adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
  • adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. GONAL-f is given to stimulate the ovaries to produce more than one egg at a time;
  • adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). GONAL-f is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
  • adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.

The medicine can only be obtained with a prescription.

How is GONAL-f used?

Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems.

GONAL-f is given by injection under the skin once a day. If the powder is being used, it should be mixed with the solvent provided just before use. The dose of GONAL-f and how often it is given depend on why it is being used and on the patient’s response to treatment. After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.

For more information, see the package leaflet.

How does GONAL-f work?

The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH. In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.

Previously, the FSH used in medicines was extracted from urine. The follitropin alfa in GONAL-f is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.

How has GONAL-f been studied?

GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate. It has also been studied as part of assisted reproductive techniques in 470 women. In these studies, GONAL-f was compared with human FSH that had been extracted from urine.

GONAL-f, in combination with LH, has also been studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism. Because these conditions are rare, GONAL-f was not compared with any other treatments in these studies, and the low number of patients in the studies was considered to be acceptable.

In the studies of women, the main measures of effectiveness were the number of eggs collected, the number of women who released eggs and the number of follicles produced in the ovaries (small sacs that hold the eggs). In men, the studies looked at the number of men who started to produce sperm within the first 18 months of treatment.

What benefit has GONAL-f shown during the studies?

GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH. GONAL-f was also as effective as human FSH at stimulating the ovaries during assisted reproductive techniques.

GONAL-f was effective in triggering egg development in women with severe LH and FSH deficiency. In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm.

What is the risk associated with GONAL-f?

The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with GONAL-f, see the package leaflet.

GONAL-f should not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons. In women, GONAL-f must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.

In some women, the ovaries can over-respond to stimulation. This is called ‘ovarian hyperstimulation syndrome’. Doctors and patients must be aware of this possibility.

Why has GONAL-f been approved?

The CHMP decided that GONAL-f’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about GONAL-f

The European Commission granted a marketing authorisation valid throughout the European Union for GONAL-f to Merck Serono Europe Ltd. on 20 October 1995. The marketing authorisation is valid for an unlimited period.

For more information about treatment with GONAL-f, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
GONAL-f : EPAR - Summary for the public BG = bălgarski 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public ES = español 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public CS = čeština 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public DA = dansk 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public DE = Deutsch 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public ET = eesti keel 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public EL = elliniká 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public EN = English 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public FR = français 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public IT = italiano 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public LV = latviešu valoda 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public LT = lietuvių kalba 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public HU = magyar 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public MT = Malti 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public NL = Nederlands 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public PL = polski 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public PT = português 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public RO = română 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public SK = slovenčina 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public SL = slovenščina 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public FI = suomi 31/08/2006 28/09/2010
GONAL-f : EPAR - Summary for the public SV = svenska 31/08/2006 28/09/2010

This EPAR was last updated on 19/03/2014 .

Authorisation details

Product details

Product details for GONAL-f
NameGONAL-f
Agency product numberEMEA/H/C/000071
Active substance

follitropin alfa

International non-proprietary name (INN) or common name

follitropin alfa

Therapeutic area Infertility, FemaleReproductive Techniques, AssistedAnovulationHypogonadism
Anatomical therapeutic chemical (ATC) code G03GA05

Publication details

Publication details for GONAL-f
Marketing-authorisation holder

Merck Serono Europe Ltd.

Revision17
Date of issue of marketing authorisation valid throughout the European Union20/10/1995

Contact address:

Merck Serono Europe Ltd.
56 Marsh Wall
London 
E14 9TP
United Kingdom

Product information

Product information

28/10/2013  GONAL-f -EMEA/H/C/000071 -N/0118

Name Language First published Last updated
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014
GONAL-f : EPAR - Product Information SV = svenska 07/08/2009 19/03/2014

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.


Name Language First published Last updated
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011
GONAL-f : EPAR - All Authorised presentations SV = svenska 31/08/2006 04/07/2011

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
GONAL-f : EPAR - Procedural steps taken before authorisation SV = svenska 31/08/2006  
GONAL-f : EPAR - Scientific Discussion SV = svenska 31/08/2006  

Authorised

This medicine is approved for use in the European Union