Suboxone (buprenorphine;naloxone)
- Region
- 🇪🇺 EU
- Active substance
- buprenorphine;naloxone
- Company
- Indivior Europe Limited
- Status
- Withdrawn
- Therapeutic area
- Opioid-Related Disorders
- CHMP opinion
- Thu 27 Jul 2006
- EU approval
- Tue 26 Sep 2006
- Application
- EMEA/H/C/000697
- ATC
- N07BC51
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zubsolv Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.