Selincro

RSS

nalmefene

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

Overview

This is a summary of the European public assessment report (EPAR) for Selincro. 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 Selincro.

This EPAR was last updated on 15/12/2017

Authorisation details

Product details
Name
Selincro
Agency product number
EMEA/H/C/002583
Active substance
Nalmefene hydrochloride dihydrate
International non-proprietary name (INN) or common name
nalmefene
Therapeutic area (MeSH)
Alcohol-Related Disorders
Anatomical therapeutic chemical (ATC) code
N07BB05
Publication details
Marketing-authorisation holder
H. Lundbeck A/S
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
25/02/2013
Contact address
Ottiliavej 9
DK-2500 Valby
Denmark

Product information

08/12/2017 Selincro - EMEA/H/C/002583 - PSUSA/00010120/201702

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

Drugs used in alcohol dependence

Therapeutic indication

Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.

Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.

Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Assessment history

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