Sprycel

Medicinal product

(Invented) name

Sprycel

Active substance (s)

Dazatinibas

Strength

10 mg/ml

Pharmaceutical form

milteliai geriamajai suspensijai

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

Powder for oral suspension	1 ml
Dazatinibas	10 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
101377	87480	1087480	buteliukas	milteliai (33 g), buteliuko adaperis ir geriamasis švirkštas N1		Receptinis	EU/1/06/363/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-11-20	Registruotas