Sprycel

Medicinal product

(Invented) name

Sprycel

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

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2006-11-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

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
43035	56804	1056804	buteliukas	N30		Receptinis	EU/1/06/363/012	Netiekiama	-	-	No	-	-
43036	56805	1056805	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/06/363/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-11-20	Registruotas