MabThera

Medicinal product

(Invented) name

MabThera

Active substance (s)

Rituksimabas

Strength

1600 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FA01, Rituximab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

1998-06-02

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

Solution for injection	13.4 ml
Rituksimabas	1600 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
66306	80831	1080831	flakonas	13,4 ml N1		Receptinis	EU/1/98/067/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-06-02	Registruotas