Iressa

Medicinal product

(Invented) name

Iressa

Active substance (s)

Gefitinibas

Strength

250 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)

L01EB01, gefitinib

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2009-06-24

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.
Gefitinibas	250 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
36974	50586	1050586	lizdinė plokštelė	N30 (3x10, perforuota)		Receptinis	EU/1/09/526/001	Netiekiama	-	-	No	-	-
50148	64024	1064024	lizdinė plokštelė	N30		Receptinis	EU/1/09/526/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-06-24	Registruotas