Gefitinib Zentiva [Gefitinib Alvogen]

Medicinal product

(Invented) name

Gefitinib Zentiva [Gefitinib Alvogen]

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

Zentiva k.s., Čekija

Date of authorisation

2018-10-08

Date of renewal

Documents

4278 Gefitinib Zentiva RPP 2021 09 22.docx

4278 Pakuotės lapelis 2021 09 22.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0271/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
100268	86377	1086377	lizdinė plokštelė	N30		Receptinis	LT/1/18/4278/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-29	Išregistruotas
2018-10-08	Registruotas