Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xolair   
Auth. number : EU/1/05/319
INN : omalizumab
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03D - Other anti-asthmatics for systemic use
Chemical subgroup: R03DX - Other anti-asthmatics for systemic use
Chemical substance: R03DX05 - Omalizumab
(See WHO ATC Index)
Indication: Xolair is indicated in adults, adolescents and children (6 to <12 years of age).

Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and older)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to <12 years of age)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/10/2005 Centralised - Authorisation EMEA/H/C/606 (2005)4255 of 25/10/2005
22/02/2006 Centralised - Variation EMEA/H/C/606/IB/6
Updated with Decision(2006)1748 of 24/04/2006
31/03/2006 Centralised - Variation EMEA/H/C/606/II/4
31/03/2006 Centralised - Variation EMEA/H/C/606/II/5
31/03/2006 Centralised - Variation EMEA/H/C/606/II/1
26/04/2006 Centralised - Variation EMEA/H/C/606/II/2 (2006)1748 of 24/04/2006
04/05/2006 Centralised - Variation EMEA/H/C/606/II/3
01/06/2007 Centralised - Variation EMEA/H/C/606/II/7 (2007)2342 of 30/05/2007
25/02/2008 Centralised - Variation EMEA/H/C/606/II/10
25/02/2008 Centralised - Variation EMEA/H/C/606/II/9
25/02/2008 Centralised - Variation EMEA/H/C/606/II/12
25/02/2008 Centralised - Variation EMEA/H/C/606/II/8
30/04/2008 Centralised - Variation EMEA/H/C/606/II/11
30/04/2008 Centralised - Variation EMEA/H/C/606/II/13
29/07/2008 Centralised - Variation EMEA/H/C/606/II/16
29/07/2008 Centralised - Variation EMEA/H/C/606/II/15
09/01/2009 Centralised - Variation EMEA/H/C/606/II/17 (2009)49 of 07/01/2009
12/02/2009 Centralised - Variation EMEA/H/C/606/X/18 (2009)1023 of 10/02/2009
30/07/2009 Centralised - Variation EMEA/H/C/606/II/18 (2009)6111 of 27/07/2009
27/11/2009 Centralised - Variation EMEA/H/C/606/II/20
12/01/2010 Centralised - Variation EMEA/H/C/606/II/22, 23, 25
27/01/2010 Centralised - Variation EMEA/H/C/606/II/19 (2010)515 of 25/01/2010
11/03/2010 Centralised - Variation EMEA/H/C/606/II/24
31/03/2010 Centralised - Variation EMEA/H/C/606/II/26 (2010)2264 of 30/03/2010
08/09/2010 Centralised - Renewal EMEA/H/C/606/R/27 (2010)6231 of 06/09/2010
16/11/2010 Centralised - Variation EMEA/H/C/606/II/21 (2010)8127 of 12/11/2010
21/01/2011 Centralised - Variation EMEA/H/C/606/IG/32/G
Updated with Decision(2011)4466 of 17/06/2011
30/03/2011 Centralised - Variation EMEA/H/C/606/II/28
23/06/2011 Centralised - Variation EMEA/H/C/606/II/29, 31, 30, 32 (2011)4466 of 17/06/2011
02/02/2012 Centralised - Variation EMEA/H/C/606/IB/38
Updated with Decision(2012)3553 of 25/05/2012
21/02/2012 Centralised - Variation EMEA/H/C/606/IA/40
Updated with Decision(2012)3553 of 25/05/2012
20/03/2012 Centralised - Variation EMEA/H/C/606/IB/39
Updated with Decision(2012)3553 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/606/II/37 (2012)3553 of 25/05/2012
24/10/2013 Centralised - Variation EMEA/H/C/606/II/46
Updated with Decision(2014)1463 of 28/02/2014
04/03/2014 Centralised - Variation EMEA/H/C/606/II/48 (2014)1463 of 28/02/2014
24/07/2014 Centralised - Variation EMEA/H/C/606/II/54