Buvidal (buprenorphine)
- Region
- 🇪🇺 EU
- Active substance
- buprenorphine
- Company
- Camurus AB
- Status
- Authorised
- Therapeutic area
- Opioid-Related Disorders
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Tue 20 Nov 2018
- Application
- EMEA/H/C/004651
- ATC
- N07BC01
- Official record
- www.ema.europa.eu
Indication
Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
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- 🇪🇺 Suboxone Withdrawn · Indivior Europe Limited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.
- 🇪🇺 Sixmo Withdrawn · L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
- 🇪🇺 Buprenorphine Neuraxpharm Authorised · Neuraxpharm Pharmaceuticals S.L.
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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.