Tabrecta

Medicinal product

(Invented) name

Tabrecta

Active substance (s)

Kapmatinibas

Strength

150 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	150 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
108911	95017	1095017	lizdinė plokštelė	N60		Receptinis	EU/1/22/1650/001	Netiekiama	-	-	No	-	-
108912	95018	1095018	lizdinė plokštelė	N120		Receptinis	EU/1/22/1650/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-20	Registruotas