Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Selincro   
Auth. number : EU/1/12/815
Active substance : nalmefene
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07B - Drugs used in addictive disorders
Chemical subgroup: N07BB - Drugs used in alcohol dependence
Chemical substance: N07BB05 - Nalmefene
(See WHO ATC Index)
Indication: Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [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 DRL two weeks after initial assessment.
Marketing Authorisation Holder: H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/02/2013 Centralised - Authorisation EMEA/H/C/2583 (2013)1188 of 25/02/2013
30/05/2013 Centralised - Variation EMEA/H/C/IAin/2/G
Updated with Decision(2014)3534 of 22/05/2014
24/07/2013 Centralised - Variation EMEA/H/C/2538/IB/3/G
Updated with Decision(2014)3534 of 22/05/2014
27/09/2013 Centralised - Variation EMEA/H/C/2583/IA/4
Updated with Decision(2014)3534 of 22/05/2014
13/12/2013 Centralised - Notification EMEA/H/C/2538/N/7
Updated with Decision(2014)3534 of 22/05/2014
27/05/2014 Centralised - Yearly update (2014)3534 of 22/05/2014
19/12/2014 Centralised - Variation EMEA/H/C/2583/IAIN/12
Updated with Decision(2015)3664 of 27/05/2015
19/12/2014 Centralised - Variation EMEA/H/C/2583/IAIN/11/G
Updated with Decision(2015)3664 of 27/05/2015
29/05/2015 PSUSA - Modification EMEA/H/C/PSUSA/10120/201408 (2015)3664 of 27/05/2015