Lazcluze

Medicinal product

(Invented) name

Lazcluze

Active substance (s)

Lazertinibas

Strength

80 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)

L01EB09, lazertinib

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2025-01-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Lazertinibas	80 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
116352	102454	1102454	lizdinė plokštelė	N56		Receptinis	EU/1/24/1886/001	Netiekiama	-	-	No	-	-
116356	102457	1102457	buteliukas	N60		Receptinis	EU/1/24/1886/002	Netiekiama	-	-	No	-	-
116357	102458	1102458	buteliukas	N90		Receptinis	EU/1/24/1886/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-20	Registruotas