buprenorphine / naloxone
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.
Suboxone : EPAR - Medicine overview (PDF/114.64 KB)
First published: 19/10/2006
Last updated: 28/07/2020
Suboxone : EPAR - Risk-management-plan summary (PDF/59.79 KB)
First published: 28/07/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Indivior Europe Limited
|Date of issue of marketing authorisation valid throughout the European Union||
27 Windsor Place
08/02/2021 Suboxone - EMEA/H/C/000697 - IA/0051
- 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
Please note that the size of the above document can exceed 50 pages.
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Other nervous system drugs
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.