Erlotinib Krka

Medicinal product

(Invented) name

Erlotinib Krka

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2020-03-12

Date of renewal

Documents

4525_4527 Pakuotės lapelis 2023 02 02.docx

4525_4527 Erlotinib Krka PCS PL 2023 02 02.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0842/002/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
103421	89523	1089523	lizdinė plokštelė	N30		Receptinis	LT/1/20/4526/001	Netiekiama	-	-	No	-	-
103422	89524	1089524	lizdinė plokštelė	N60		Receptinis	LT/1/20/4526/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-28	Išregistruotas
2020-03-12	Registruotas