Sprycel

Medicinal product

(Invented) name

Sprycel

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

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	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
28321	30851	1030851	buteliukas	N60		Receptinis	EU/1/06/363/002	Tiekiama	-	2025-05-31	No	-	-
28322	30852	1030852	lizdinė plokštelė	N56		Receptinis	EU/1/06/363/005	Netiekiama	-	-	No	-	-
28323	30853	1030853	dalomoji lizdinė plokštelė	N60x1		Receptinis	EU/1/06/363/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-11-20	Registruotas