Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

Active substance (s)

Dazatinibas

Strength

140 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	140 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
108352	94456	1094456	lizdinė plokštelė	N30		Receptinis	EU/1/21/1540/021	Netiekiama	-	-	No	-	-
108353	94457	1094457	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/022	Netiekiama	-	-	No	-	-
108354	94458	1094458	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/21/1540/023	Netiekiama	-	-	No	-	-
108355	94459	1094459	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/024	Netiekiama	-	-	No	-	-

Stadijos

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