buprenorphine / naloxone

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 17/01/2023

Authorisation details

Product details
Agency product number
Active substance
  • buprenorphine
  • naloxone
International non-proprietary name (INN) or common name
  • buprenorphine
  • naloxone
Therapeutic area (MeSH)
Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Indivior Europe Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address
27 Windsor Place
Dublin 2

Product information

16/01/2023 Suboxone - EMEA/H/C/000697 - IB/0055

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Product information documents contain:

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.

Assessment history

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