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EMA Product

Puregon

Product approved by European Medicines Agency (EU)

Basic Information

Puregon

Regulatory Information

EMEA/H/C/000086

Authorised

May 2, 1996

December 20, 1995

35

November 28, 2024

Company Information

Netherlands

Kloosterstraat 6 5349 AB, Oss

Organon NV

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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).

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