SELINCRO Film-coated tablet Ref.[9788] Active ingredients: Nalmefene

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: H. Lundbeck A/S, Ottiliavej 9, DK-2500, Valby, Denmark

Product name and form

Selincro 18 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White, oval, biconvex, 6.0 × 8.75 mm film-coated tablet engraved with “S” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate).

Excipient with known effect: Each film-coated tablet contains 60.68 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nalmefene

Nalmefene is an opioid system modulator with a distinct ÎŒ, ÎŽ, and Îș receptor profile. Nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence, without physical withdrawal symptoms and who do not require immediate detoxification.
List of Excipients

Tablet core:

Microcrystalline cellulose
Lactose, anhydrous
Crospovidone, type A
Magnesium stearate

Tablet coating:

Hypromellose
Macrogol 400
Titanium dioxide (E171)

Pack sizes and marketing

Blister: Clear PVC/PVdC-aluminium blisters in cardboard boxes. Pack sizes of 7, 14, 28, 42, 49 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

H. Lundbeck A/S, Ottiliavej 9, DK-2500, Valby, Denmark

Marketing authorization dates and numbers

EU/1/12/815/001 7 tablets
EU/1/12/815/002 14 tablets
EU/1/12/815/003 28 tablets
EU/1/12/815/004 42 tablets
EU/1/12/815/005 98 tablets
EU/1/12/815/006 49 tablets

Date of first authorisation: 25 February 2013
Date of latest renewal: 10 November 2017

Drugs

Drug Countries
SELINCRO Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈