Dasatinib Zentiva

Medicinal product

(Invented) name

Dasatinib Zentiva

Active substance (s)

Dazatinibas

Strength

50 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

2024-02-14

Documents

4709_Dasatan Zentiva_perr2024-02-14.docx

4709_pakuotes lapelis_2024-02-14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4593/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Dazatinibas	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
106167	92268	1092268	lizdinė plokštelė	N60		Receptinis	LT/1/21/4709/001	Netiekiama	2025-09-08	2025-11-30	Yes	2025-09-10	2025-11-30	Download
106168	92269	1092269	dalomoji lizdinė plokštelė	N60x1		Receptinis	LT/1/21/4709/002	Netiekiama	-	-	No	-	-
106169	92270	1092270	talpyklė	N60		Receptinis	LT/1/21/4709/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-14	Perregistruotas
2021-03-18	Registruotas