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EMA Product

Pergoveris

Product approved by European Medicines Agency (EU)

Basic Information

Pergoveris

Regulatory Information

EMEA/H/C/000714

Authorised

June 25, 2007

16

October 11, 2024

Company Information

the netherlands

Gustav Mahlerplein 102 Ito Toren 1082 MA Amsterdam

Merck Europe BV

Active Substances Detail

follitropin alfalutropin alfa

Detailed Information

Therapeutic Indication

### Therapeutic indication Pergoveris is indicated for the stimulation of follicular development in women with severe luteinising-hormone (LH) and follicle-stimulating-hormone 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 Pergoveris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pergoveris. For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist.

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