Lazcluze

Medicinal product

(Invented) name

Lazcluze

Active substance (s)

Lazertinibas

Strength

240 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	240 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
116353	102455	1102455	lizdinė plokštelė	N14		Receptinis	EU/1/24/1886/004	Netiekiama	-	-	No	-	-
116354	102456	1102456	lizdinė plokštelė	N28		Receptinis	EU/1/24/1886/005	Netiekiama	-	-	No	-	-
116358	102459	1102459	buteliukas	N30		Receptinis	EU/1/24/1886/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-20	Registruotas