LUMYKRAS

Medicinal product

(Invented) name

LUMYKRAS

Active substance (s)

Sotorasibas

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)

L01XX73, sotorasib

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2022-01-06

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

Kiekvienoje plėvele dengtoje tabletėje yra	1 vnt.
Sotorasibas	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
113753	99870	1099870	lizdinė plokštelė	N120		Receptinis	EU/1/21/1603/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-06	Registruotas