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 17/05/2022

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
13
Date of issue of marketing authorisation valid throughout the European Union
24/02/2013
Contact address

Ottiliavej 9
DK-2500 Valby
Denmark

Product information

16/05/2022 Selincro - EMEA/H/C/002583 - IB/0028

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

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

Changes since initial authorisation of medicine

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