Anpheros Search · Treatment

Buprenorphine

Also known as: Buvidal · Buprenorphine Neuraxpharm · BRIXADI · Butrans · SUBLOCADE · buprenorphine transdermal system

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In short

In the European Union, buprenorphine is indicated for the substitution treatment of opioid drug dependence within a comprehensive framework of medical, social, and psychological treatment, intended for adults and adolescents aged 15 or 16 years and older who agree to be treated. In the United States, it is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine is listed by the cited source as having an approved use for unspecified disorders due to the use of opioids.

From: Source: European Medicines Agency (EMA), Buprenorphine Neuraxpharm — EPAR, 16/05/2025. © European Medicines Agency. · Source: European Medicines Agency (EMA), Buvidal — EPAR, 21/03/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1819 buprenorphine
EMA
EMEA/H/C/004651, EMEA/H/C/006188

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Buprenorphine Neuraxpharm

Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.

Source: European Medicines Agency (EMA), Buprenorphine Neuraxpharm — EPAR, 16/05/2025. © European Medicines Agency.

Document date: 16/05/2025 · Official document →

EMA (EU) Buvidal

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

Source: European Medicines Agency (EMA), Buvidal — EPAR, 21/03/2025. © European Medicines Agency.

Document date: 21/03/2025 · Official document →

FDA (USA) SUBLOCADE

1 INDICATIONS AND USAGE SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBLOCADE contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. ( 1 ) SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support. ( 1 )

Data provided by the U.S. Food and Drug Administration.

Document date: 20260727 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Buprenorphine approved for in the European Union?

Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction. (Source: European Medicines Agency (EMA), Buprenorphine Neuraxpharm — EPAR, 16/05/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Buprenorphine Neuraxpharm — EPAR, 16/05/2025. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Buvidal — EPAR, 21/03/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →