Arzerra

Medicinal product

(Invented) name

Arzerra

Active substance (s)

Ofatumumabas

Strength

100 mg

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)

L01FA02, Ofatumumab

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2010-04-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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	5 ml
Ofatumumabas	100 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
40780	54517	1054517	flakonas	N3		Receptinis	EU/1/10/625/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-27	Išregistruotas
2010-04-19	Registruotas