Is Remimazolam approved by the US FDA?

Drugs@FDA lists 1 application product line for Remimazolam, including BYFAVO (Prescription).

Is Remimazolam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Remimazolam: Byfavo.

Are there safety signals or safety updates for Remimazolam?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-05-07).

Active substance

Remimazolam

US FDA 1
EMA 1
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BYFAVO	EQ 20MG BASE/VIAL	powder · intravenous	ACACIA	Prescription	2 Jul 2020

EMA European Union — centrally authorised medicines

Byfavo Paion Pharma GmbH · Authorised · authorised 26 Mar 2021 · ATC N05CD14

Therapeutic indication (EMA)

Remimazolam is indicated in adults for procedural sedation. Remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Safety signals and safety-related labeling changes

EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
US FDA 13 Jan 2023 BYFAVO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for remimazolam →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.