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.
Selincro : EPAR - Summary for the public (PDF/77.4 KB)
First published: 13/03/2013
Last updated: 13/03/2013
|Agency product number||
Nalmefene hydrochloride dihydrate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
H. Lundbeck A/S
|Date of issue of marketing authorisation valid throughout the European Union||
08/12/2017 Selincro - EMEA/H/C/002583 - PSUSA/00010120/201702
- 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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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.