Dasatinib Zentiva

Medicinal product

(Invented) name

Dasatinib Zentiva

Active substance (s)

Dazatinibas

Strength

100 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)

L01EA02, dasatinib

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2021-03-18

Date of renewal

Documents

4709_4710 Dasatinib Zentiva PCS PL 2022 05 27.docx

4709_4710 Pakuotės lapelis 2022 05 27.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4593/005/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dazatinibas	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
106170	92271	1092271	lizdinė plokštelė	N30		Receptinis	LT/1/21/4710/001	Netiekiama	-	-	No	-	-
106171	92272	1092272	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/21/4710/002	Netiekiama	-	-	No	-	-
106172	92273	1092273	talpyklė	N30		Receptinis	LT/1/21/4710/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-30	Išregistruotas
2021-03-18	Registruotas