Puregon

follitropin beta

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Puregon?

Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.

What is Puregon used for?

Puregon is used to treat infertility in women in the following situations:

  • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);
  • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time.

Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).

Puregon can only be obtained with a prescription.

How is Puregon used?

Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems. Puregon is given as a ‘subcutaneous’ injection (under the skin) or into a muscle. The powder should be mixed with the solvent provided just before use. The patient or their partner may carry out the injections. Puregon should only be administered by people who have been trained by the doctor and have access to expert advice. The dose and frequency of administration of Puregon depend on its use (see above) and the patient’s response to treatment. For a full description of the doses, please see the package leaflet.

How does Puregon work?

The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH). In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles. Previously, the FSH used as a medicine was extracted from urine. The follitropin beta in Puregon 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 Puregon been studied?

Puregon’s use in women undergoing fertility treatment has been studied in 981 patients. The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness. Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate. In men, Puregon was studied to see its effect on sperm production in 49 patients. In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine.

What benefit has Puregon shown during the studies?

Puregon was as effective as the comparator in all of the studies. Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.

What is the risk associated with Puregon?

The most common side effects reported are a reaction and pain at the injection site. In 4% of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment. Doctors and patients must be aware of this possibility. For a full list of all side effects reported with Puregon, see the package leaflet.

Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients. Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus. It must not be used in men with testicular failure. In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding. For the full list of restrictions, see the package leaflet.

Why has Puregon been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon’s benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism. The Committee recommended that Puregon be given marketing authorisation.

Other information about Puregon

The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996. The marketing authorisation holder is N.V. Organon. The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.

Name Language First published Last updated
Puregon : EPAR - Summary for the public BG = bălgarski 2009-07-31  
Puregon : EPAR - Summary for the public ES = español 2009-07-31  
Puregon : EPAR - Summary for the public CS = čeština 2009-07-31  
Puregon : EPAR - Summary for the public DA = dansk 2009-07-31  
Puregon : EPAR - Summary for the public DE = Deutsch 2009-07-31  
Puregon : EPAR - Summary for the public ET = eesti keel 2009-07-31  
Puregon : EPAR - Summary for the public EL = elliniká 2009-07-31  
Puregon : EPAR - Summary for the public EN = English 2009-07-31  
Puregon : EPAR - Summary for the public FR = français 2009-07-31  
Puregon : EPAR - Summary for the public IT = italiano 2009-07-31  
Puregon : EPAR - Summary for the public LV = latviešu valoda 2009-07-31  
Puregon : EPAR - Summary for the public LT = lietuvių kalba 2009-07-31  
Puregon : EPAR - Summary for the public HU = magyar 2009-07-31  
Puregon : EPAR - Summary for the public MT = Malti 2009-07-31  
Puregon : EPAR - Summary for the public NL = Nederlands 2009-07-31  
Puregon : EPAR - Summary for the public PL = polski 2009-07-31  
Puregon : EPAR - Summary for the public PT = português 2009-07-31  
Puregon : EPAR - Summary for the public RO = română 2009-07-31  
Puregon : EPAR - Summary for the public SK = slovenčina 2009-07-31  
Puregon : EPAR - Summary for the public SL = slovenščina 2009-07-31  
Puregon : EPAR - Summary for the public FI = suomi 2009-07-31  
Puregon : EPAR - Summary for the public SV = svenska 2009-07-31  

This EPAR was last updated on 06/04/2017 .

Authorisation details

Product details

Product details for Puregon
NamePuregon
Agency product numberEMEA/H/C/000086
Active substance

follitropin beta

International non-proprietary name (INN) or common name

follitropin beta

Therapeutic area InfertilityHypogonadism
Anatomical therapeutic chemical (ATC) code G03GA06

Publication details

Publication details for Puregon
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision24
Date of issue of marketing authorisation valid throughout the European Union03/05/1996

Contact address:

Merck Sharp & Dohme Limited
Herford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Product information

Product information

02/03/2017  Puregon -EMEA/H/C/000086 -N/0093

Name Language First published Last updated
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06
Puregon : EPAR - Product Information SV = svenska 2009-07-31 2017-04-06

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
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14
Puregon : EPAR - All Authorised presentations SV = svenska 2008-08-31 2016-06-14

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

In the female:

Puregon is indicated for the treatment of female infertility in the following clinical situations:

  • anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate;
  • controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).

In the male:

  • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Puregon : EPAR - Procedural steps taken before authorisation SV = svenska 2008-08-31  
Puregon : EPAR - Scientific Discussion SV = svenska 2008-08-31  

Authorised

This medicine is approved for use in the European Union