Glivec

Medicinal product

(Invented) name

Glivec

Active substance (s)

Imatinibas

Strength

400 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)

L01EA01, imatinib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2003-11-11

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.
Imatinibas	400 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
26082	28671	1028671	lizdinė plokštelė	N10 (PVDC/alu)		Receptinis	EU/1/01/198/009	Netiekiama	-	-	No	-	-
26083	28672	1028672	lizdinė plokštelė	N30 (PVDC/alu)		Receptinis	EU/1/01/198/010	Netiekiama	-	-	No	-	-
26084	28673	1028673	lizdinė plokštelė	N90 (PVDC/alu)		Receptinis	EU/1/01/198/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-11-11	Registruotas