Sprycel

Medicinal product

(Invented) name

Sprycel

Active substance (s)

Dazatinibas

Strength

100 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	100 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
34170	36525	1036525	buteliukas	N30		Receptinis	EU/1/06/363/010	Netiekiama	-	-	No	-	-
34171	36526	1036526	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/06/363/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-11-20	Registruotas