Dasatinib Krka

Medicinal product

(Invented) name

Dasatinib Krka

Active substance (s)

Dazatinibas

Strength

80 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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2019-10-01

Date of renewal

2024-11-21

Documents

4436-41_Dasatinib Krka_perr2024-11-21.docx

4436-41_pakuotes lapelis_2024-11-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4594/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dazatinibas	80 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
102446	88547	1088547	lizdinė plokštelė	N30		Receptinis	LT/1/19/4439/001	Netiekiama	-	-	No	-	-
102447	88548	1088548	lizdinė plokštelė	N60		Receptinis	LT/1/19/4439/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-21	Perregistruotas
2019-10-01	Registruotas