Byfavo
remimazolam
Table of contents
Overview
Byfavo is a sedative medicine given to adults before a medical test or procedure to make them feel relaxed and sleepy (sedated).
Byfavo is also used in adults to bring about and maintain general anaesthesia (state of controlled unconsciousness to prevent pain during surgery).
Byfavo contains the active substance remimazolam.
-
List item
Byfavo : EPAR - Medicine overview (PDF/126.39 KB)
First published: 20/04/2021
Last updated: 18/04/2023 -
-
List item
Byfavo : EPAR - Risk-management-plan summary (PDF/102.96 KB)
First published: 20/04/2021
Last updated: 18/04/2023
Authorisation details
Product details | |
---|---|
Name |
Byfavo
|
Agency product number |
EMEA/H/C/005246
|
Active substance |
remimazolam besilate
|
International non-proprietary name (INN) or common name |
remimazolam
|
Therapeutic area (MeSH) |
Conscious Sedation
|
Anatomical therapeutic chemical (ATC) code |
N05CD14
|
Additional 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 |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
26/03/2021
|
Contact address |
Heussstraße 25 |
Product information
15/06/2023 Byfavo - EMEA/H/C/005246 - IB/0014/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.