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EMA Product

Luveris

Product approved by European Medicines Agency (EU)

Basic Information

Luveris

Regulatory Information

EMEA/H/C/000292

Authorised

November 29, 2000

22

July 22, 2024

Company Information

the netherlands

Gustav Mahlerplein 102 Ito Toren 1082 MA Amsterdam

Merck Europe BV

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level <1.2 IU/l.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Luveris. 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 Luveris.

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