Byfavo

Medicinal product

(Invented) name

Byfavo

Active substance (s)

Remimazolamas

Strength

50 mg

Pharmaceutical form

milteliai injekcinio ar infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CD14, remimazolam

Marketing authorisation holder

PAION Pharma GmbH, Vokietija

Date of authorisation

2021-03-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for injection or infusion	1 vnt.
Remimazolamas	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
110843	96954	1096954	flakonas	N10		Receptinis	EU/1/20/1505/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas