Buprenorphine Neuraxpharm (buprenorphine)
- Region
- 🇪🇺 EU
- Active substance
- buprenorphine
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Opioid-Related Disorders
- CHMP opinion
- Thu 17 Oct 2024
- EU approval
- Thu 19 Dec 2024
- Application
- EMEA/H/C/006188
- ATC
- N07BC01
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Suboxone Withdrawn · Indivior Europe Limited
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- 🇪🇺 Sixmo Withdrawn · L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
- 🇪🇺 Buvidal Authorised · Camurus AB
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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.