Erlotinib Actavis

Medicinal product

(Invented) name

Erlotinib Actavis

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)

L01XE03, Erlotinib

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

2017-06-13

Date of renewal

Documents

4088_1-3 Erlotinib_Actavis_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2591/002/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
63745	78188	1078188	lizdinė plokštelė	N30		Receptinis	LT/1/17/4088/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-12-05	Išregistruotas
2017-06-13	Registruotas