Product class: Authorized package
Medicinal product class: For human use
Package code: 1846076
Name of medicinal product: BYFAVO
Active substances:
Estonian, English, Latin
ATC code: N05CD14
Dosage form: powder for solution for injection
Route of administration: intravenous use
Strengh: 20mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Remimazolam is indicated in adults for procedural sedation
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: 12 April 2024
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: PAION Deutschland GmbH 
Marketing authorization number: EU/1/20/1505 
Marketing authorization issued on: 26 March 2021 
Marketing authorization expires on: 29 March 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Ravi alustamisel kehtib koguseline piirang 30 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml
Korduval väljakirjutamisel kehtib koguseline piirang 60 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml
Entry/Changing date: 10 January 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription