Dasatinib Viatris [Dasatinib Mylan]

Medicinal product

(Invented) name

Dasatinib Viatris [Dasatinib Mylan]

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

Viatris Limited, Airija

Date of authorisation

2019-11-22

Date of renewal

2025-01-31

Documents

4489__Dasat_Viatris_perr2025-01-31.docx

4489_pakuotes lapelis_2025-01-31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4595/002/DC

Marketing authorisation procedure

Decentralizuota 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
102860	88961	1088961	lizdinė plokštelė	N60		Receptinis	LT/1/19/4489/001	Netiekiama	-	-	No	-	-	Download
102861	88962	1088962	dalomoji lizdinė plokštelė	N60x1		Receptinis	LT/1/19/4489/002	Netiekiama	-	-	No	-	-
102862	88963	1088963	talpyklė	N60		Receptinis	LT/1/19/4489/003	Netiekiama	-	-	No	-	-
104994	91096	1091096	lizdinė plokštelė	N56		Receptinis	LT/1/19/4489/004	Netiekiama	-	-	No	-	-
104995	91097	1091097	dalomoji lizdinė plokštelė	N56x1		Receptinis	LT/1/19/4489/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-31	Perregistruotas
2019-11-22	Registruotas