Kisplyx

Medicinal product

(Invented) name

Kisplyx

Active substance (s)

Lenvatinibas

Strength

10 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)

L01EX08, Lenvatinib

Marketing authorisation holder

Eisai GmbH, Vokietija

Date of authorisation

2016-08-25

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

Capsule, hard	1 vnt.
Lenvatinibas	10 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
66343	80868	1080868	lizdinė plokštelė	N30		Receptinis	EU/1/16/1128/002	Netiekiama	-	-	No	-	-
102811	88912	1088912	lizdinė plokštelė	N60		Receptinis	EU/1/16/1128/005	Netiekiama	-	-	No	-	-
102812	88913	1088913	lizdinė plokštelė	N90		Receptinis	EU/1/16/1128/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-25	Registruotas