Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Extavia   
Auth. number : EU/1/08/454
INN : Interferon beta-1b
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AB - Interferons
Chemical substance: L03AB08 - Interferon beta-1b
(See WHO ATC Index)
Indication: Extavia is indicated for the treatment of:
• Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis
• Patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years.
• Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
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
22/05/2008 Centralised - Authorisation EMEA/H/C/933 (2008)2155 of 20/05/2008
11/06/2008 Centralised - Variation EMEA/H/C/933/IA/1
Updated with Decision(2009)968 of 06/02/2009
10/10/2008 Centralised - Variation EMEA/H/C/933/N/2
Updated with Decision(2009)968 of 06/02/2009
22/10/2008 Centralised - Variation EMEA/H/C/933/IA/4
27/11/2008 Centralised - Variation EMEA/H/C/933/II/3
12/12/2008 Centralised - Variation EMEA/H/C/933/IA/5
Updated with Decision(2009)968 of 06/02/2009
17/12/2008 Centralised - Variation EMEA/H/C/933/IA/9
17/12/2008 Centralised - Variation EMEA/H/C/933/IA/10
17/12/2008 Centralised - Variation EMEA/H/C/933/IA/11
15/01/2009 Centralised - Variation EMEA/H/C/933/IA/12
Updated with Decision(2009)2295 of 25/03/2009
26/01/2009 Centralised - Variation EMEA/H/C/933/IA/14, 15, 16
10/02/2009 Centralised - Variation EMEA/H/C/933/IA/17
10/02/2009 Centralised - Variation (2009)968 of 06/02/2009
26/02/2009 Centralised - Variation EMEA/H/C/933/II/7
27/03/2009 Centralised - Variation EMEA/H/C/933/II/8, 13 (2009)2295 of 25/03/2009
16/06/2009 Centralised - Variation EMEA/H/C/933/IA/19
20/07/2009 Centralised - Variation EMEA/H/C/933/IA/20
06/11/2009 Centralised - Variation EMEA/H/C/933/IA/21
Updated with Decision(2010)2257 of 30/03/2010
08/02/2010 Centralised - Variation EMEA/H/C/933/IA/23
Updated with Decision(2010)2257 of 30/03/2010
08/02/2010 Centralised - Variation EMEA/H/C/933/IA/22
Updated with Decision(2010)2257 of 30/03/2010
01/04/2010 Centralised - Variation EMEA/H/C/933/II/24 (2010)2257 of 30/03/2010
07/04/2010 Centralised - Variation EMEA/H/C/933/IA/25
09/06/2010 Centralised - Variation EMEA/H/C/933/N/26
Updated with Decision(2011)3440 of 12/05/2011
03/08/2010 Centralised - Variation EMEA/H/C/933/IA/29
08/09/2010 Centralised - Variation EMEA/H/C/933/IA/30/G
22/12/2010 Centralised - Variation EMEA/H/C/933/IA/32/G
Updated with Decision(2011)3440 of 12/05/2011
25/01/2011 Centralised - Variation EMEA/H/C/933/II/28/G
31/01/2011 Centralised - Variation EMEA/H/C/933/II/27/G
16/05/2011 Centralised - Variation (2011)3440 of 12/05/2011
30/05/2012 Centralised - Variation EMEA/H/C/933/II/36 (2012)3559 of 25/05/2012
13/12/2012 Centralised - Variation EMEA/H/C/933/II/50/G
Updated with Decision(2013)9717 of 18/12/2013
21/12/2012 Centralised - Renewal EMEA/H/C/933/R/51 (2012)9937 of 20/12/2012
02/01/2013 Centralised - Variation EMEA/H/C/933/IAin/47/G
Updated with Decision(2012)9937 of 20/12/2012
05/04/2013 Centralised - Variation EMEA/H/C/933/IAin/55/G
Updated with Decision(2013)9717 of 18/12/2013
16/08/2013 Centralised - Variation EMEA/H/C/933/N/58
Updated with Decision(2013)9717 of 18/12/2013
26/09/2013 Centralised - Variation EMEA/H/C/933/N/59
Updated with Decision(2013)9717 of 18/12/2013
20/12/2013 Centralised - Variation (2013)9717 of 18/12/2013
25/04/2014 Centralised - Variation EMEA/H/C/933/II/61
Updated with Decision(2014)6359 of 04/09/2014
08/09/2014 Centralised - Variation EMEA/H/C/933/II/64 (2014)6359 of 04/09/2014