Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BYFAVO
Active substances:
Remimazolam
Estonian, English, Latin
ATC code: N05CD14
Dosage form: powder for solution for injection
Strength: 20mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Remimazolam is indicated in adults for procedural sedation
Safety features: Yes
: 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: March 26, 2021 
Marketing authorization expires on: March 29, 2026 
Marketing authorization procedure type: Centralised 
Assessment report:   
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
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1846076  BYFAVO  powder for solution for injection  20mg 10TK  Prescription      12.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere