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 | |
---|---|
Marketing-authorisation holder |
Indivior Europe Limited
|
Revision |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
26/09/2006
|
Contact address |
27 Windsor Place
Dublin 2 Ireland |
Product information
16/01/2023 Suboxone - EMEA/H/C/000697 - IB/0055
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.