Varlota

Medicinal product

(Invented) name

Varlota

Active substance (s)

Erlotinibas

Strength

100 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)

L01EB02, erlotinib

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2016-10-11

Date of renewal

2024-03-14

Documents

3981_pakuotes lapelis_2024-03-14.docx

3981_Varlota_perr2024-03-14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0432/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Erlotinibas	100 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
63801	78245	1078245	lizdinė plokštelė	N30		Receptinis	LT/1/16/3981/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-03-14	Perregistruotas
2016-10-11	Registruotas