Suboxone
buprenorphine / naloxone
Table of contents
Overview
Suboxone is a medicine to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.
Suboxone is contains two active substances, buprenorphine and naloxone.
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List item
Suboxone : EPAR - Medicine overview (PDF/114.64 KB)
First published: 19/10/2006
Last updated: 28/07/2020
EMA/305684/2020 -
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List item
Suboxone : EPAR - Risk-management-plan summary (PDF/59.79 KB)
First published: 28/07/2020
Authorisation details
Product details | |
---|---|
Name |
Suboxone
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Agency product number |
EMEA/H/C/000697
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Opioid-Related Disorders
|
Anatomical therapeutic chemical (ATC) code |
N07BC51
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Publication details | |
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Marketing-authorisation holder |
Indivior Europe Limited
|
Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
26/09/2006
|
Contact address |
27 Windsor Place
Dublin 2 Ireland |
Product information
08/02/2021 Suboxone - EMEA/H/C/000697 - IA/0051
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Other nervous system drugs
Therapeutic indication
Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.