Qarziba

Medicinal product

(Invented) name

Qarziba

Active substance (s)

Dinutuksimabas beta

Strength

4,5 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

Recordati Netherlands B.V., Nyderlandai

Date of authorisation

2017-05-08

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
Dinutuksimabas beta	4,5 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
68332	82908	1082908	flakonas	4,5 ml N1		Receptinis	EU/1/17/1191/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-05-08	Registruotas