XALKORI

Medicinal product

(Invented) name

XALKORI

Active substance (s)

Krizotinibas

Strength

200 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01ED01, crizotinib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2012-10-23

Date of renewal

Documents

Xalkori paciento kortele.pdf

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

Capsule, hard	1 vnt.
Krizotinibas	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
54271	68261	1068261	lizdinė plokštelė	N60		Receptinis	EU/1/12/793/001	Netiekiama	-	-	No	-	-
54272	68262	1068262	buteliukas	N60		Receptinis	EU/1/12/793/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-10-23	Registruotas