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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
N07BB05
ATC Item
nalmefene
Pharmacotherapeutic Group
Drugs used in alcohol dependence
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Nalmefene hydrochloride dihydrate | N/A | nalmefene hydrochloride dihydrate |
| nalmefene hydrochloride dihydrate | N/A | nalmefene hydrochloride dihydrate |
EMA Name
Selincro
Medicine Name
Selincro
Aliases
N/ANo risk management plan link.
