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 19/11/2021

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
N.V. Organon
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
02/05/1996
Contact address

Kloosterstraat 6
5349 AB, Oss
Netherlands

Product information

27/10/2021 Puregon - EMEA/H/C/000086 - N/0123

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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