Vyxeos liposomal [Vyxeos]

Medicinal product

(Invented) name

Vyxeos liposomal [Vyxeos]

Active substance (s)

Daunorubicinas/Citarabinas

Strength

44 mg/100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XY01, cytarabine and daunorubicin

Marketing authorisation holder

Jazz Pharmaceuticals Ireland Ltd., Airija

Date of authorisation

2018-08-23

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 infusion	1 vnt.
Daunorubicinas	44 mg
Citarabinas	100 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
100102	86210	1086210	flakonas	N1		Receptinis	EU/1/18/1308/001	Tiekiama	2025-06-16	-	No	-	-
100103	86211	1086211	flakonas	N2		Receptinis	EU/1/18/1308/002	Netiekiama	-	-	No	-	-
100104	86212	1086212	flakonas	N3		Receptinis	EU/1/18/1308/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-23	Registruotas