Puregon

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follitropin beta

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

Overview

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).

This EPAR was last updated on 13/11/2018

Authorisation details

Product details
Name
Puregon
Agency product number
EMEA/H/C/000086
Active substance
follitropin beta
International non-proprietary name (INN) or common name
follitropin beta
Therapeutic area (MeSH)
  • Infertility
  • Hypogonadism
Anatomical therapeutic chemical (ATC) code
G03GA06
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
02/05/1996
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

26/09/2018 Puregon - EMEA/H/C/000086 - IG/0968

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

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

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