Erlotinib Viatris [Erlotinib Mylan]

Medicinal product

(Invented) name

Erlotinib Viatris [Erlotinib Mylan]

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

Viatris Limited, Airija

Date of authorisation

2017-09-05

Date of renewal

2024-03-25

Documents

4124 Erlotinib Viatris PCS PL 2024 04 19.docx

4124 Pakuotės lapelis 2024 04 19.docx

Stage

Sustabdytas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0461/003/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
97670	83765	1083765	lizdinė plokštelė	N30		Receptinis	LT/1/17/4124/001	Netiekiama	-	-	No	-	-	Download
97671	83766	1083766	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/17/4124/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-11	Sustabdytas
2024-03-25	Perregistruotas
2017-09-05	Registruotas