Rituzena

Medicinal product

(Invented) name

Rituzena

Active substance (s)

Rituksimabas

Strength

500 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)

L01FA01, Rituximab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2017-07-13

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	50 ml
Rituksimabas	500 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
68826	83423	1083423	flakonas	50 ml N1		Receptinis	EU/1/17/1206/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-12	Išregistruotas
2017-07-13	Registruotas