follitropin alfa / lutropin alfa
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.
Pergoveris : EPAR - Summary for the public (PDF/76.11 KB)
First published: 22/06/2009
Last updated: 17/05/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
Gustav Mahlerplein 102
17/08/2022 Pergoveris - EMEA/H/C/000714 - N/0081
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Sex hormones and modulators of the genital system
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.