Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tysabri   
Auth. number : EU/1/06/346
INN : Natalizumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA23 - Natalizumab
(See WHO ATC Index)
Indication: Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:Adult patients aged 18 years and over with high disease activity despite treatment with a beta-interferon.
  • These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2 hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
or
  • Adult patients aged 18 years and over with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Marketing Authorisation Holder: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, 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
28/06/2006 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/603 (2006)3045 of 27/06/2006
30/06/2006 Centralised - Authorisation EMEA/H/C/603 (2006)3046 of 27/06/2006
13/10/2006 Centralised - Variation EMEA/H/C/603/IA/4
Updated with Decision(2006)5917 of 28/11/2006
27/11/2006 Centralised - Variation EMEA/H/C/603/II/3
27/11/2006 Centralised - Variation EMEA/H/C/603/II/1
04/12/2006 Centralised - Variation EMEA/H/C/603/II/7 (2006)5917 of 28/11/2006
22/12/2006 Centralised - Variation EMEA/H/C/603/N/5
Updated with Decision(2008)1744 of 25/04/2008
27/02/2007 Centralised - Variation EMEA/H/C/603/II/6
22/03/2007 Centralised - Variation EMEA/H/C/603/IA/8
28/03/2007 Centralised - Variation EMEA/H/C/603/II/7
07/07/2007 Centralised - Variation EMEA/H/C/603/IA/11
09/07/2007 Centralised - Variation EMEA/H/C/603/IA/12
30/07/2007 Centralised - Variation EMEA/H/C/603/IA/14
17/09/2007 Centralised - Variation EMEA/H/C/603/N/15
Updated with Decision(2008)1744 of 25/04/2008
24/10/2007 Centralised - Variation EMEA/H/C/603/II/13
26/02/2008 Centralised - Variation EMEA/H/C/603/II/16
31/03/2008 Centralised - Variation EMEA/H/C/603/II/18
30/04/2008 Centralised - Variation EMEA/H/C/603/II/17 (2008)1744 of 25/04/2008
26/06/2008 Centralised - Variation EMEA/H/C/603/II/21 (2008)3156 of 20/06/2008
28/07/2008 Centralised - Variation EMEA/H/C/603/II/19
08/09/2008 Centralised - Variation EMEA/H/C/603/II/20 (2008)4982 of 03/09/2008
02/10/2008 Centralised - Variation EMEA/H/C/603/II/23
02/10/2008 Centralised - Variation EMEA/H/C/603/II/22
04/11/2008 Centralised - Variation EMEA/H/C/603/II/25 (2008)6604 of 30/10/2008
23/12/2008 Centralised - Variation EMEA/H/C/603/II/24 (2008)8927 of 19/12/2008
27/01/2009 Centralised - Variation EMEA/H/C/603/II/26 (2009)534 of 23/01/2009
28/05/2009 Centralised - Variation EMEA/H/C/603/II/27 (2009)4219 of 26/05/2009
17/12/2009 Centralised - Variation EMEA/H/C/603/IA/30
11/05/2010 Referral EMEA/H/C/603/A-20/29 (2010)3156 of 10/05/2010
12/05/2010 Referral EMEA/H/C/603/A-20/29 (2010)3157 of 10/05/2010
21/09/2010 Centralised - Variation EMEA/H/C/603/IA/33/G
Updated with Decision(2010)8636 of 29/11/2010
21/09/2010 Centralised - Variation EMEA/H/C/603/IB/34
23/09/2010 Centralised - Variation EMEA/H/C/603/IA/35
Updated with Decision(2010)8636 of 29/11/2010
09/11/2010 Centralised - Variation EMEA/H/C/603/IB/32/G
02/12/2010 Centralised - Variation EMEA/H/C/603/II/31 (2010)8636 of 29/11/2010
06/01/2011 Centralised - Variation EMEA/H/C/603/IA/39
23/02/2011 Centralised - Variation EMEA/H/C/603/II/37 (2011)1190 of 21/02/2011
27/04/2011 Centralised - Variation EMEA/H/C/603/II/38 (2011)2940 of 20/04/2011
20/06/2011 Centralised - Variation EMEA/H/C/603/H/C/II/41 (2011)4402 of 16/06/2011
21/06/2011 Centralised - Variation EMEA/H/C/603/II/41 (2011)4401 of 16/06/2011
23/06/2011 Centralised - Renewal EMEA/H/C/603/R/40 (2011)4472 of 17/06/2011
09/11/2011 Centralised - Variation EMEA/H/C/603/IA/43
Updated with Decision(2012)3605 of 25/05/2012
15/11/2011 Centralised - Variation EMEA/H/C/603/N/42
Updated with Decision(2012)3605 of 25/05/2012
31/05/2012 Centralised - Variation EMEA/H/C/603/II/54 (2012)3605 of 25/05/2012
23/11/2012 Centralised - Variation EMEA/H/C/603/II/56, 57 (2012)8596 of 19/11/2012
17/01/2013 Centralised - Variation EMEA/H/C/603/II/58
Updated with Decision(2013)3819 of 13/06/2013
17/06/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/603/T/61 (2013)3819 of 13/06/2013
11/07/2013 Centralised - Variation EMEA/H/C/603/II/59/G (2013)4447 of 09/07/2013
29/08/2013 Centralised - Modification EMEA/H/C/603/II/60, EMEA/H/C/603/PSUR/II/60 (2013)5610 of 26/08/2013
26/11/2013 Centralised - Variation EMEA/H/C/603/IA/63