Xolair

Medicinal product

(Invented) name

Xolair

Active substance (s)

Omalizumabas

Strength

150 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	150 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
28911	31423	1031423	flakonas	N1 ir ampulė (2 ml) injekcinio vandens		Receptinis	EU/1/05/319/002	Netiekiama	-	-	No	-	-
28912	31424	1031424	flakonas	N4 (4×1) ir ampulės (2 ml) injekcinio vandens		Receptinis	EU/1/05/319/003	Netiekiama	-	-	No	-	-
28913	31425	1031425	flakonas	N10 (10×1) ir ampulės (2 ml) injekcinio vandens		Receptinis	EU/1/05/319/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-10-25	Registruotas