This is a summary of the European public assessment report (EPAR) for Zubsolv. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zubsolv. For practical information about using Zubsolv, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
N07BC51
ATC Item
buprenorphine, combinations
Pharmacotherapeutic Group
Other nervous system drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| buprenorphine hydrochloride | N/A | 丁丙诺啡 |
| naloxone hydrochloride dihydrate | N/A | Naloxone Hydrochloride/Pentazocine Hydrochloride |
| Buprenorphine hydrochloride | N/A | 丁丙诺啡 |
| Naloxone hydrochloride dihydrate | N/A | Naloxone Hydrochloride/Pentazocine Hydrochloride |
EMA Name
Zubsolv
Medicine Name
Zubsolv
Aliases
N/ANo risk management plan link.
