Evoltra

Medicinal product

(Invented) name

Evoltra

Active substance (s)

Klofarabinas

Strength

1 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BB06, Clofarabine

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2006-05-29

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

Concentrate for solution for infusion	1 ml
Klofarabinas	1 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
25444	28052	1028052	flakonas	20 ml N3		Receptinis	EU/1/06/334/001	Netiekiama	-	-	No	-	-
25445	28053	1028053	flakonas	20 ml N4		Receptinis	EU/1/06/334/002	Netiekiama	-	-	No	-	-
25446	28054	1028054	flakonas	20 ml N10		Receptinis	EU/1/06/334/003	Netiekiama	-	-	No	-	-
25447	28055	1028055	flakonas	20 ml N20		Receptinis	EU/1/06/334/004	Netiekiama	-	-	No	-	-
40807	54544	1054544	flakonas	20 ml N1		Receptinis	EU/1/06/334/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-05-29	Registruotas