Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

Active substance (s)

Dazatinibas

Strength

50 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	50 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
108336	94440	1094440	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/005	Netiekiama	-	-	No	-	-
108337	94441	1094441	lizdinė plokštelė	N60		Receptinis	EU/1/21/1540/006	Netiekiama	-	-	No	-	-
108338	94442	1094442	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/007	Netiekiama	-	-	No	-	-
108339	94443	1094443	dalomoji lizdinė plokštelė	N60×1		Receptinis	EU/1/21/1540/008	Netiekiama	-	-	No	-	-

Stadijos

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