Byfavo (remimazolam)
- Region
- 🇪🇺 EU
- Active substance
- remimazolam
- Company
- Paion Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Conscious Sedation
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Fri 26 Mar 2021
- Application
- EMEA/H/C/005246
- ATC
- N05CD14
- Official record
- www.ema.europa.eu
Indication
Remimazolam is indicated in adults for procedural sedation. Remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.
Regulatory milestones
No milestones recorded in the last year.
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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.