Luveris

RSS

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 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.

This EPAR was last updated on 23/02/2021

Authorisation details

Product details
Name
Luveris
Agency product number
EMEA/H/C/000292
Active substance
lutropin alfa
International non-proprietary name (INN) or common name
lutropin alfa
Therapeutic area (MeSH)
  • Ovulation Induction
  • Infertility, Female
Anatomical therapeutic chemical (ATC) code
G03GA07
Publication details
Marketing-authorisation holder
Merck Europe B.V. 
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
29/11/2000
Contact address

Gustav Mahlerplein 102
Ito Toren
1082 MA Amsterdam
The Netherlands

Product information

07/01/2021 Luveris - EMEA/H/C/000292 - IB/0087

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

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.

Assessment history

How useful was this page?

Add your rating