Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-03-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
108348	94452	1094452	lizdinė plokštelė	N30		Receptinis	EU/1/21/1540/017	Netiekiama	-	-	No	-	-
108349	94453	1094453	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/018	Netiekiama	-	-	No	-	-
108350	94454	1094454	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/21/1540/019	Netiekiama	-	-	No	-	-
108351	94455	1094455	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-25	Išregistruotas
2022-03-24	Registruotas