Remimazolam (1) – Byfavo®
Procedural sedation
Characteristics
| Start date | 01.01.2026 – Marketing authorisation: 26.03.2021 |
|---|---|
| Resolution | 18.06.2026 |
| INN | Remimazolam |
| Brand name | Byfavo® |
| Pharm. company | Paion Pharma GmbH |
| G-BA Procedure ID | D-1288 |
| ATC code | N05CD14 Benzodiazepine derivatives (N05CD) |
| Therapeutic area | Other diseases |
| Reason for procedure | Initial assessment |
Studies and Results
Adults requiring procedural sedation
- An additional benefit is not proven.
- The pharmaceutical manufacturer has not provided any data to assess the additional benefit of remimazolam compared with the appropriate comparator therapy.
- Overall, an additional benefit is not proven for remimazolam in procedural sedation in adults.
- Overall assessment
- The additional benefit of remimazolam for procedural sedation in adults is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Remimazolam (2) | Byfavo® | Paion Pharma GmbH | Induction and maintenance of general anaesthesia | 12,000,000 | 100% additional benefit not proven | |
| Remimazolam (1) | Byfavo® | Paion Pharma GmbH | Procedural sedation | 2,620,000–2,730,000 | 100% additional benefit not proven |
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