Unituxin

Medicinal product

(Invented) name

Unituxin

Active substance (s)

Dinutuksimabas

Strength

3,5 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)

L01FX06, Dinutuximab beta

Marketing authorisation holder

United Therapeutics Europe, Ltd., Jungtinė Karalystė

Date of authorisation

2015-08-14

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Dinutuksimabas	3,5 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
63419	77858	1077858	flakonas	5 ml N1		Receptinis	EU/1/15/1022/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-20	Išregistruotas
2015-08-14	Registruotas