Selincro (nalmefene)
- Region
- 🇪🇺 EU
- Active substance
- nalmefene
- Company
- H. Lundbeck A/S
- Status
- Authorised
- Therapeutic area
- Alcohol-Related Disorders
- EU approval
- Sun 24 Feb 2013
- Application
- EMEA/H/C/002583
- ATC
- N07BB05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.