Scemblix

Medicinal product

(Invented) name

Scemblix

Active substance (s)

Asciminibas

Strength

40 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)

L01EA06, asciminib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2022-08-25

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.
Asciminibas	40 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
109308	95414	1095414	lizdinė plokštelė	N20		Receptinis	EU/1/22/1670/003	Netiekiama	-	-	No	-	-
109309	95415	1095415	lizdinė plokštelė	N60		Receptinis	EU/1/22/1670/004	Netiekiama	-	-	No	-	-
109968	96078	1096078	lizdinė plokštelė	N180 (3×60)		Receptinis	EU/1/22/1670/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-25	Registruotas