Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

Active substance (s)

Dazatinibas

Strength

20 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	20 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
108332	94436	1094436	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/001	Netiekiama	-	-	No	-	-
108333	94437	1094437	lizdinė plokštelė	N60		Receptinis	EU/1/21/1540/002	Netiekiama	-	-	No	-	-
108334	94438	1094438	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/003	Netiekiama	-	-	No	-	-
108335	94439	1094439	dalomoji lizdinė plokštelė	N60×1		Receptinis	EU/1/21/1540/004	Netiekiama	-	-	No	-	-

Stadijos

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