remimazolam
Byfavo · ATC code N05CD14
- Key facts
- Active substance
- remimazolam
- Drug class
- Benzodiazepine drug
- ATC code
- N05CD14
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Byfavo 20 mg powder for solution for injection · Byfavo 50 mg powder for concentrate for solution for injection/infusion
- Marketing authorisation holder
- Paion Pharma GmbH
- Information as of
- 2026-10-28
Key facts
Remimazolam (Byfavo) is a short-acting intravenous benzodiazepine used for procedural sedation and for induction and maintenance of general anaesthesia in adults.
What it is used for
- Byfavo 20 mg: procedural sedation in adults.
- Byfavo 50 mg: intravenous induction and maintenance of general anaesthesia in adults.
Dosing
- Byfavo 20 mg, sedation with opioid (under 65 years): initial dose 5 mg over 1 min, then 2.5 mg over 15 sec as needed, at least 2 minutes apart; without opioid initial dose 7 mg. Elderly (≥ 65 years), ASA-PS III-IV or under 50 kg: 2.5-5 mg, top-ups 1.25-2.5 mg.
- Byfavo 50 mg, induction: infusion at 6 mg/min, up-titrated to a maximum of 12 mg/min if needed; most adults require 10-40 mg.
- Byfavo 50 mg, maintenance: start at 1 mg/min (range 0.1-2.5 mg/min); additional boluses of 6 mg possible, maximum three within 60 min.
- No dose adjustment in renal impairment; in severe hepatic impairment effects may be more pronounced and last longer.
- Only by staff experienced in sedation or anaesthesia with continuous monitoring; flumazenil must be available.
Contraindications
- Hypersensitivity to the active substance, other benzodiazepines or any excipient.
- Unstable myasthenia gravis.
Important warnings
- Cardiorespiratory reactions: respiratory depression, bradycardia and hypotension; special attention in elderly patients and impaired cardiac or respiratory function.
- Concomitant opioids may cause profound sedation, respiratory depression, coma and death.
- Avoid alcohol and other CNS depressants.
- Potential for abuse and dependence.
- Contains dextran, which can cause anaphylactic reactions.
Side effects
- Sedation (Byfavo 20 mg): most frequent are hypotension (37.2%), respiratory depression (13.1%) and bradycardia (6.8%).
- General anaesthesia (Byfavo 50 mg): most frequent are hypotension (51%), nausea (22.1%), vomiting (15.2%) and bradycardia (12.8%).
- Common: headache, dizziness; anaphylactic reaction (frequency not known).
Interactions
- Opioids and other CNS depressants (e.g. antipsychotics, other benzodiazepines, barbiturates, propofol, ketamine, sedative antidepressants, alcohol) enhance sedation and cardiorespiratory depression.
Pregnancy and breastfeeding
- As a precaution, preferably avoid during pregnancy.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ByfavoPaion Pharma GmbH · EMEA/H/C/005246
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Byfavo
- Liechtenstein
- Byfavo
- Norway
- Byfavo
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Byfavo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/byfavo-epar-product-information_en.pdf
- Wikidata (CC0): ATC N05CD.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.