Gefitinib Norameda

Medicinal product

(Invented) name

Gefitinib Norameda

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

UAB Norameda, Lietuva

Date of authorisation

2018-09-10

Date of renewal

2022-12-19

Documents

4254 Gefitinib Norameda PCS 2023 03 22.docx

4254_pakuotes lapelis_2022-12-19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4100/001/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
100066	86174	1086174	lizdinė plokštelė	N30		Receptinis	LT/1/18/4254/001	Tiekiama	-	-	No	-	-	Download
100067	86175	1086175	lizdinė plokštelė	N30x1		Receptinis	LT/1/18/4254/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-19	Perregistruotas
2018-09-10	Registruotas