buprenorphine/naloxone
Suboxone, Zubsolv · ATC code N07BC51
Also known as: Buprenorphin/Naloxon, Buprenorphine / Naloxone · Brand names: Suboxone, Zubsolv, Bupensan Duo, Bowielone, Bulnexo, Bupensanduo, Buprenorphin/Naloxon G.L. Pharma
- Key facts
- Active substance
- buprenorphine/naloxone (INN: buprenorphine / naloxone)
- ATC code
- N07BC51
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Suboxone 2 mg/0.5 mg sublingual tablets / Suboxone 8 mg/2 mg sublingual tablets / Suboxone 16 mg/4 mg sublingual tablets · Suboxone 2 mg/0.5 mg sublingual film / Suboxone 4 mg/1 mg sublingual film / Suboxone 8 mg/2 mg sublingual film · Zubsolv 0.7 mg/0.18 mg sublingual tablets / Zubsolv 1.4 mg/0.36 mg sublingual tablets / Zubsolv 2.9 mg/0.71 mg sublingual tablets
- Marketing authorisation holder
- Indivior Europe Limited, Accord Healthcare S.L.U.
- Information as of
- 2026-10-27
Key facts
Buprenorphine/naloxone combines a partial opioid agonist with an opioid antagonist for substitution treatment of opioid dependence; naloxone is intended to deter intravenous misuse.
What it is used for
- Substitution treatment for opioid drug dependence within a framework of medical, social and psychological treatment
- Adults and adolescents over 15 years of age who have agreed to be treated for addiction
Dosing
- Under supervision of a physician experienced in addiction; induction only when clear signs of withdrawal are evident
- Heroin/short-acting opioids: first dose not less than 6 hours after last use; methadone: reduce to max 30 mg/day first, first dose not less than 24 hours after last methadone
- Suboxone: starting dose 4 mg/1 mg, repeatable up to 12 mg/3 mg on day 1; maximum single daily dose 24 mg buprenorphine
- Suboxone: after stabilisation, dosing every other day at twice the daily dose or 3 times a week may be possible
- Zubsolv: starting dose 1.4 mg/0.36 mg or 2.9 mg/0.71 mg a day; not interchangeable with other buprenorphine products (different bioavailability)
- Sublingual use; further schemes in the full text
Contraindications
- Hypersensitivity to the active substances or any excipient
- Severe respiratory insufficiency; severe hepatic impairment
- Acute alcoholism or delirium tremens
- Concomitant opioid antagonists (naltrexone, nalmefene) for alcohol or opioid dependence
Important warnings
- Misuse, abuse and diversion: risks include overdose, infections, respiratory depression and hepatic injury
- Underdosing may lead to self-medication with opioids, alcohol or benzodiazepines
- Buprenorphine may precipitate withdrawal in methadone-dependent patients
- Precautions against misuse, e.g. avoiding multiple refills early in treatment and regular follow-up
Side effects
- Most common: constipation and withdrawal-type symptoms such as insomnia, headache, nausea, hyperhidrosis and pain
- Considered serious: seizure, vomiting, diarrhoea and elevated liver function tests
- Film: oral hypoesthesia (sublingual) or oral mucosal erythema (buccal)
Interactions
- Not to be taken with alcohol or alcohol-containing medicines (increased sedation)
- Benzodiazepines and other sedatives: increased risk of sedation, respiratory depression, coma and death; dose and duration limited
Pregnancy and breastfeeding
- No or limited data in pregnancy; towards the end of pregnancy, respiratory depression in the newborn is possible
- Long-term use during the last three months may cause a neonatal withdrawal syndrome
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Austria
- Bupensan DuoG.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- BowieloneEthypharm · 1 register entry
- BulnexoAlkaloid-Int D.O.O. · 1 register entry
- BupensanduoG.L. Pharma Gmbh · 1 register entry
- Buprenorphin/Naloxon G.L. PharmaG.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- SuboxoneLİBA LABORATUARLARI A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 26 more European countries
- Belgium
- Libroxar
- Bulgaria
- Булнексо
- Croatia
- Bulnexo, Bunalict, Bupensanduo
- Cyprus
- Libroxar
- Czechia
- Bupensanduo, Libroxar
- Denmark
- Bunalict, Buprenorphin/Naloxon G.L. Pharma, Buprenorphin/Naloxon Viatris
- Estonia
- Bupensanduo
- Finland
- Bunalict, Buprenorphine/Naloxone G.L. Pharma, Buprenorphine/Naloxone Viatris
- France
- Buprenorphine / Naloxone Viatris, Buprenorphine/Naloxone Arrow, Buprenorphine/Naloxone G.L. Pharma, Buprenorphine/Naloxone Viatris
- Greece
- Libroxar
- Hungary
- Bulnexo
- Iceland
- Suboxone, Zubsolv
- Ireland
- Bulexin, Buprenorphine/Naloxone Pinewood
- Italy
- Bunamol, Buprenorfina E Naloxone Ethypharm, Buprenorfina E Naloxone G.L. Pharma, Buprenorfina E Naloxone Mylan Pharma
- Latvia
- Bupensanduo
- Liechtenstein
- Suboxone, Zubsolv
- Lithuania
- Bupensanduo
- Luxembourg
- Libroxar
- Malta
- Libroxar
- Netherlands
- Bunalict, Buprenorfine/Naloxon Viatris, Buprenorphine Hydrochloride/Naloxon Hydrochloride Dihydrate Aurobindo, Libroxar
- Norway
- Bunalict, Suboxone, Zubsolv
- Portugal
- Buprenorfina + Naloxona Generis
- Slovakia
- Bupensanduo
- Slovenia
- Bulnexo
- Spain
- Buprenorfina/Naloxona Aurovitas
- Sweden
- Bunalict, Buprenorphine/Naloxone G.L. Pharma, Buprenorphine/Naloxone Viatris
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Suboxone – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/suboxone-epar-product-information_en.pdf
- European Medicines Agency. Zubsolv – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zubsolv-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.