Litak

Medicinal product

(Invented) name

Litak

Active substance (s)

Kladribinas

Strength

2 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BB04, Cladribine

Marketing authorisation holder

Lipomed GmbH, Vokietija

Date of authorisation

2004-04-14

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

solution for injection	1 ml
Kladribinas	2 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
26856	29421	1029421	flakonas	5 ml N1		Receptinis	EU/1/04/275/001	Tiekiama	-	-	No	-	-
26857	29422	1029422	flakonas	5 ml N5		Receptinis	EU/1/04/275/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-04-14	Registruotas