Defitelio

Medicinal product

(Invented) name

Defitelio

Active substance (s)

Defibrotidas

Strength

80 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)

B01AX01, Defibrotide

Marketing authorisation holder

Gentium S.r.l , Italija

Date of authorisation

2013-10-18

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
Defibrotidas	80 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
57639	71758	1071758	flakonas	2,5 ml N10		Receptinis	EU/1/13/878/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-10-18	Registruotas