Gazyvaro

Medicinal product

(Invented) name

Gazyvaro

Active substance (s)

Obinutuzumabas

Strength

1000 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)

L01FA03, Obinutuzumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2014-07-23

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

Concentrate for solution for infusion	40 ml
Obinutuzumabas	1000 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
59723	73957	1073957	flakonas	N1		Receptinis	EU/1/14/937/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-07-23	Registruotas