Tabrecta

Medicinal product

(Invented) name

Tabrecta

Active substance (s)

Kapmatinibas

Strength

200 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)

L01EX17, capmatinib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2022-06-20

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

Film-coated tablet	1 vnt.
Kapmatinibas	200 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
108913	95019	1095019	lizdinė plokštelė	N60		Receptinis	EU/1/22/1650/003	Netiekiama	-	-	No	-	-
108914	95020	1095020	lizdinė plokštelė	N120		Receptinis	EU/1/22/1650/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-20	Registruotas