Luveris
lutropin alfa
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
G03GA07
|
Publication details | |
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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 |
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
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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.