CHMP recommends Byfavo for procedural sedation .- Paion AG.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Byfavo, intended for procedural sedation. The applicant for this medicinal product is PAION Netherlands B.V. Byfavo will be available as a powder for solution for injection (20 mg). The active substance of Byfavo is remimazolam, an ultra-short acting benzodiazepine sedative (ATC code: N05CD14). The benefits with Byfavo are its ability to induce sedation during diagnostic or therapeutic procedures. The most common side effects are hypotension, hypoxia and bradycardia.