Varlota

Medicinal product

(Invented) name

Varlota

Active substance (s)

Erlotinibas

Strength

50 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

Alvogen Pharma Trading Europe EOOD, Bulgarija

Date of authorisation

2016-10-11

Date of renewal

Documents

3981 Varlota PCS PL 2021 12 23.docx

3981 Pakuotės lapelis 2021 12 23.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0432/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Erlotinibas	50 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
63800	78244	1078244	lizdinė plokštelė	N30		Receptinis	LT/1/16/3981/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-28	Išregistruotas
2016-10-11	Registruotas