Pergoveris

RSS

follitropin alfa / lutropin alfa

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

Overview

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.

This EPAR was last updated on 29/11/2021

Authorisation details

Product details
Name
Pergoveris
Agency product number
EMEA/H/C/000714
Active substance
  • follitropin alfa
  • lutropin alfa
International non-proprietary name (INN) or common name
  • follitropin alfa
  • lutropin alfa
Therapeutic area (MeSH)
Infertility, Female
Anatomical therapeutic chemical (ATC) code
G03GA30
Publication details
Marketing-authorisation holder
Merck Europe B.V. 
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
25/06/2007
Contact address

Gustav Mahlerplein 102
Ito Toren
1082 MA Amsterdam
The Netherlands

Product information

14/10/2021 Pergoveris - EMEA/H/C/000714 - II/0075

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

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.

Assessment history

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