Byfavo

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remimazolam

Authorised
This medicine is authorised for use in the European Union.

Overview

Byfavo is a sedative medicine given to adults before a medical test or procedure to make them feel relaxed and sleepy (sedated).

Byfavo contains the active substance remimazolam.

This EPAR was last updated on 06/01/2023

Authorisation details

Product details
Name
Byfavo
Agency product number
EMEA/H/C/005246
Active substance
remimazolam
International non-proprietary name (INN) or common name
remimazolam
Therapeutic area (MeSH)
Conscious Sedation
Anatomical therapeutic chemical (ATC) code
N05CD
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
PAION Deutschland GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Heussstraße 25
52078 Aachen
Germany

Product information

21/11/2022 Byfavo - EMEA/H/C/005246 - PSUSA/00010924/202201

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Remimazolam is indicated in adults for procedural sedation.

Assessment history

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