Cladribine Zentiva

Medicinal product

(Invented) name

Cladribine Zentiva

Active substance (s)

Kladribinas

Strength

10 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AA40, cladribine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2026-10-02

Date of renewal

Documents

6161_Cladribine Zentiva.docx

6161_pakuotes lapelis_2026-10-02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6516/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Kladribinas	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
122458	108568	1108568	lizdinė plokštelė	N1		Receptinis	LT/1/26/6161/001	Netiekiama	-	-	No	-	-
122459	108569	1108569	lizdinė plokštelė	N4		Receptinis	LT/1/26/6161/002	Netiekiama	-	-	No	-	-
122460	108570	1108570	lizdinė plokštelė	N6		Receptinis	LT/1/26/6161/003	Netiekiama	-	-	No	-	-
122461	108571	1108571	lizdinė plokštelė	N10		Receptinis	LT/1/26/6161/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-10-02	Registruotas