SELINCRO

Main information

  • Trade name:
  • SELINCRO nalmefene (as hydrochloride dihydrate) 18 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SELINCRO nalmefene (as hydrochloride dihydrate) 18 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215784
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215784

SELINCRO nalmefene (as hydrochloride dihydrate) 18 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Lundbeck Australia Pty Ltd

Postal Address

PO Box 1973,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

17/06/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SELINCRO nalmefene (as hydrochloride dihydrate) 18 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SELINCRO is indicated for the reduction of alcohol consumption in adult patients with alcohol use disorder who have an average daily consumption of

alcohol of more than 60 g for men and more than 40 g for women.,SELINCRO should be prescribed only if the patient has failed to achieve an adequate

response following psychosocial intervention for at least 2 weeks.,SELINCRO should be prescribed in conjunction with continuing psychosocial support

focused on treatment adherence and reducing alcohol consumption. SELINCRO is not suitable for patients with physical withdrawal syndrome or who

require immediate detoxification.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

98 film-coated tablets (trade pack)

(S4) Prescription Only Medicine

7 film-coated tablets (starter pack)

(S4) Prescription Only Medicine

4 film-coated tablets (starter pack)

(S4) Prescription Only Medicine

14 film-coated tablets (trade pack)

(S4) Prescription Only Medicine

28 film-coated tablets (trade pack)

(S4) Prescription Only Medicine

7 film-coated tablets (trade pack)

(S4) Prescription Only Medicine

42 film-coated tablets (trade pack)

(S4) Prescription Only Medicine

Components

1. SELINCRO nalmefene (as hydrochloride dihydrate) 18 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval, biconvex, 6.0 x 8.75mm film-coated tablet engraved with "S" on

one side

Active Ingredients

nalmefene

18 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:10:26 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information