MabThera

Medicinal product

(Invented) name

MabThera

Active substance (s)

Rituksimabas

Strength

1400 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 subcutaneous injection	15 ml
Rituksimabas	1400 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
59824	74075	1074075	flakonas	15 ml N1		Receptinis	EU/1/98/067/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-06-02	Registruotas