Xolair

Medicinal product

(Invented) name

Xolair

Active substance (s)

Omalizumabas

Strength

75 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DX05, Omalizumab

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2005-10-25

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

Powder and solvent for solution for injection	1 vnt.
Omalizumabas	75 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
28910	31422	1031422	flakonas	N1 ir ampulė (2 ml) injekcinio vandens		Receptinis	EU/1/05/319/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-10-25	Registruotas