Gefitinib Mylan

Medicinal product

(Invented) name

Gefitinib Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2018-09-27

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
100299	86408	1086408	lizdinė plokštelė	N30		Receptinis	EU/1/18/1321/001	Netiekiama	-	-	No	-	-
100300	86409	1086409	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/18/1321/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-27	Išregistruotas
2018-09-27	Registruotas