Kisplyx

Medicinal product

(Invented) name

Kisplyx

Active substance (s)

Lenvatinibas

Strength

4 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	4 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
66342	80867	1080867	lizdinė plokštelė	N30		Receptinis	EU/1/16/1128/001	Netiekiama	-	-	No	-	-
102809	88910	1088910	lizdinė plokštelė	N60		Receptinis	EU/1/16/1128/003	Netiekiama	-	-	No	-	-
102810	88911	1088911	lizdinė plokštelė	N90		Receptinis	EU/1/16/1128/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-25	Registruotas