Sixmo (buprenorphine)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- buprenorphine
- Company
- L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
- Status
- Withdrawn
- Therapeutic area
- Opioid-Related Disorders
- CHMP opinion
- Fri 26 Apr 2019
- EU approval
- Wed 19 Jun 2019
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004743
- ATC
- N07BC01
- Official record
- www.ema.europa.eu
Indication
Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Suboxone Withdrawn · Indivior Europe Limited
- 🇪🇺 Zubsolv Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Buprenorphine Neuraxpharm Authorised · Neuraxpharm Pharmaceuticals S.L.
- 🇪🇺 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.