Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Exjade   
Auth. number : EU/1/06/356
INN : deferasirox
Orphan status based on designation EU/3/02/092 added on 31/08/2006
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AC - Iron chelating agents
Chemical substance: V03AC03 - Deferasirox
(See WHO ATC Index)
Indication:

Treatment of chronic iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.

Treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:

  • in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) aged 2 to 5 years,
  • in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older,
  • in patients with other anaemias aged 2 years and older. Treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

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 continues to be 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
30/08/2006 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/670 (2006)3942 of 28/08/2006
31/08/2006 Centralised - Authorisation EMEA/H/C/670 (2006)3943 of 28/08/2006
02/03/2007 Centralised - Variation EMEA/H/C/670/N/1
Updated with Decision(2007)3303 of 02/07/2007
05/07/2007 Centralised - Variation EMEA/H/C/670/II/2 (2007)3303 of 02/07/2007
21/05/2008 Centralised - Variation EMEA/H/C/670/IA/4
25/07/2008 Centralised - Variation EMEA/H/C/670/II/3 (2008)4026 of 23/07/2008
05/09/2008 Centralised - Variation EMEA/H/C/670/IB/6
Updated with Decision(2008)8809 of 17/12/2008
05/09/2008 Centralised - Variation EMEA/H/C/670/IB/5
Updated with Decision(2008)8809 of 17/12/2008
05/09/2008 Centralised - Variation EMEA/H/C/670/IB/7
Updated with Decision(2008)8809 of 17/12/2008
18/09/2008 Centralised - Variation EMEA/H/C/670/IB/8
25/09/2008 Centralised - Variation EMEA/H/C/670/IA/12
25/09/2008 Centralised - Variation EMEA/H/C/670/IA/11
25/09/2008 Centralised - Variation EMEA/H/C/670/IA/13
22/12/2008 Centralised - Variation EMEA/H/C/670/II/10 (2008)8809 of 17/12/2008
27/03/2009 Centralised - Variation EMEA/H/C/670/II/15 (2009)2316 of 25/03/2009
06/07/2009 Centralised - Variation EMEA/H/C/670/II/14
16/07/2009 Centralised - Variation EMEA/H/C/670/II/17 (2009)5763 of 14/07/2009
25/11/2009 Centralised - Variation EMEA/H/C/670/II/9, 18 (2009)9447 of 23/11/2009
13/01/2010 Centralised - Variation EMEA/H/C/670/II/16
17/03/2010 Centralised - Variation EMEA/H/C/670/II/19 (2010)1815 of 15/03/2010
23/12/2010 Centralised - Variation EMEA/H/C/670/II/20 (2010)9610 of 20/12/2010
21/01/2011 Centralised - Variation EMEA/H/C/670/IG/32/G
01/08/2011 Centralised - Renewal EMEA/H/C/670/R/21 (2011)5596 of 27/07/2011
21/12/2011 Centralised - Variation EMEA/H/C/670/II/22 (2011)9957 of 19/12/2011
26/10/2012 Centralised - Variation EMEA/H/C/670/II/31 (2012)7666 of 24/10/2012
02/01/2013 Centralised - Variation EMEA/H/C/670/II/26 (2012)9940 of 20/12/2012
25/04/2013 Centralised - Variation EMEA/H/C/670/II/25
19/09/2013 Centralised - Variation EMEA/H/C/670/II/36/G