Luveris

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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 06/09/2022

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
21
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

23/06/2022 Luveris - EMEA/H/C/000292 - II/0091

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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.

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

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