Dasatinib Accordpharma

Medicinal product

(Invented) name

Dasatinib Accordpharma

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
108320	94424	1094424	lizdinė plokštelė	N30		Receptinis	EU/1/21/1541/013	Netiekiama	-	-	No	-	-
108321	94425	1094425	lizdinė plokštelė	N56		Receptinis	EU/1/21/1541/014	Netiekiama	-	-	No	-	-
108322	94426	1094426	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/21/1541/015	Netiekiama	-	-	No	-	-
108323	94427	1094427	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1541/016	Netiekiama	-	-	No	-	-

Stadijos

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