Xolair

Medicinal product

(Invented) name

Xolair

Active substance (s)

Omalizumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Solution for injection in pre-filled pen	2 ml
Omalizumabas	300 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
111957	98072	1098072	užpildytas švirkštas	N1		Receptinis	EU/1/05/319/012	Netiekiama	-	-	No	-	-
111958	98073	1098073	užpildytas švirkštas	N3 (3×1)		Receptinis	EU/1/05/319/013	Netiekiama	-	-	No	-	-
111959	98074	1098074	užpildytas švirkštas	N6 (6×1)		Receptinis	EU/1/05/319/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-10-25	Registruotas