LUMYKRAS

Medicinal product

(Invented) name

LUMYKRAS

Active substance (s)

Sotorasibas

Strength

120 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

Film-coated tablet	1 vnt.
Sotorasibas	120 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
107829	93934	1093934	lizdinė plokštelė	N240		Receptinis	EU/1/21/1603/001	Netiekiama	-	-	No	-	-
107830	93935	1093935	lizdinė plokštelė	N720 (3×240)		Receptinis	EU/1/21/1603/002	Netiekiama	-	-	No	-	-
107831	93936	1093936	buteliukas	N240 (2×120)		Receptinis	EU/1/21/1603/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-06	Registruotas