Truxima

Medicinal product

(Invented) name

Truxima

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

2017-02-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename flakone yra	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
67807	82365	1082365	flakonas	50 ml N1		Receptinis	EU/1/16/1167/001	Netiekiama	-	-	No	-	-
117703	103807	1103807	flakonas	50 ml N2 (2×1)		Receptinis	EU/1/16/1167/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-17	Registruotas