VANFLYTA

Medicinal product

(Invented) name

VANFLYTA

Active substance (s)

Kvizartinibas

Strength

26,5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX11, quizartinib

Marketing authorisation holder

Daiichi Sankyo Europe GmbH, Vokietija

Date of authorisation

2023-11-06

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

Film-coated tablet	1 vnt.
Kvizartinibas	26,5 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
111933	98048	1098048	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/23/1768/003	Netiekiama	-	-	No	-	-
111934	98049	1098049	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/23/1768/004	Netiekiama	-	-	No	-	-
111935	98050	1098050	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/23/1768/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-06	Registruotas