Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BYFAVO
Active substances:
Estonian, English, Latin
ATC code: N05CD14
Dosage form: powder for concentrate for solution for injection/infusion
Strength: 50mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Indication: Remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.
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
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Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
3041716  BYFAVO  powder for concentrate for solution for injection/infusion  50mg 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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