Xolair

Medicinal product

(Invented) name

Xolair

Active substance (s)

Omalizumabas

Strength

150 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

Užpildytame švirkštiklyje (1 ml tirpalo) yra	1 ml
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
111951	98066	1098066	užpildytas švirkštiklis	N1		Receptinis	EU/1/05/319/027	Tiekiama	-	-	No	-	-
111952	98067	1098067	užpildytas švirkštiklis	N3 (3×1)		Receptinis	EU/1/05/319/028	Netiekiama	-	-	No	-	-
111953	98068	1098068	užpildytas švirkštiklis	N6 (6×1)		Receptinis	EU/1/05/319/029	Netiekiama	-	-	No	-	-
117664	103767	1103767	užpildytas švirkštiklis	N10 (10×1)		Receptinis	EU/1/05/319/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-10-25	Registruotas