Gefitinib Teva

Medicinal product

(Invented) name

Gefitinib Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2018-12-14

Date of renewal

2023-07-26

Documents

4304_ Gefitinib Teva_perr2023-07-26.docx

4304_ pakuotes lapelis_2023-07-26.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4152/001/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
100672	86782	1086782	lizdinė plokštelė	N30		Receptinis	LT/1/18/4304/001	Netiekiama	-	-	No	-	-	Download
100673	86783	1086783	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/18/4304/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2023-07-26	Perregistruotas
2018-12-14	Registruotas