Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

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

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	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
108344	94448	1094448	lizdinė plokštelė	N30		Receptinis	EU/1/21/1540/013	Netiekiama	-	-	No	-	-
108345	94449	1094449	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/014	Netiekiama	-	-	No	-	-
108346	94450	1094450	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/21/1540/015	Netiekiama	-	-	No	-	-
108347	94451	1094451	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/016	Netiekiama	-	-	No	-	-

Stadijos

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