Zevalin

Medicinal product

(Invented) name

Zevalin

Active substance (s)

Ibritumomabas tiuksetanas

Strength

1,6 mg/ml

Pharmaceutical form

rinkinys radiofarmaciniam preparatui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V10XX02, Ibritumomab tiuxetan(90Y)

Marketing authorisation holder

Ceft Biopharma s.r.o., Čekija

Date of authorisation

2004-01-16

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

Kit for radiopharmaceutical preparation for infusion	1 ml
Ibritumomabas tiuksetanas	1,6 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
28976	31487	1031487	flakonas	natrio acetato tirpalas (2 ml), buferinis tirpalas (10 ml), tuščias reakcijos flakonas (10 ml) N1		Receptinis	EU/1/03/264/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2004-01-16	Registruotas