Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Avonex   
Auth. number : EU/1/97/033
INN : Interferon Beta - 1a
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: L03AB07 - Interferon beta-1a
(See WHO ATC Index)
Indication: AVONEX is indicated for the treatment of- Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.- 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
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
13/03/1997 Centralised - Authorisation EMEA/H/C/102 (97)712 of 13/03/1997
28/08/1997 Centralised - Variation EMEA/H/C/102/I/1 (97)2748 of 27/08/1997
28/08/1997 Centralised - Notification EMEA/H/C/102/N/2 (97)2755 of 27/08/1997
18/08/1998 Centralised - Variation EMEA/H/C/102/II/6 (1998)2525 of 17/08/1998
28/10/1998 Centralised - Variation EMEA/H/C/102/II/6 (1998)3283 of 23/10/1998
12/11/1998 Centralised - Variation EMEA/H/C/102/I/9 (1998)3495 of 06/11/1998
08/02/1999 Centralised - Annual reassessment EMEA/H/C/102/S/14 (1998)279 of 03/02/1999
30/06/1999 Centralised - Variation EMEA/H/C/102/II/13 (1999)1655 of 18/06/1999
23/02/2000 Centralised - Annual reassessment EMEA/H/C/102/S/15 (2000)420 of 21/02/2000
14/03/2000 Centralised - Variation EMEA/H/C/102/II/16 (2000)606 of 09/03/2000
04/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/18
02/08/2000 Centralised - Variation EMEA/H/C/102/I/19 (2000)2336 of 27/07/2000
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/23
02/01/2001 Centralised - Annual reassessment EMEA/H/C/102/S/21 (2000)4296 of 28/12/2000
24/01/2001 Centralised - Variation EMEA/H/C/102/II/20 (2001)80 of 22/01/2001
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/25
13/06/2001 Centralised - Variation EMEA/H/C/102/II/24 (2001)1279 of 08/06/2001
03/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/26
05/12/2001 Centralised - Variation EMEA/H/C/102/II/27 (2001)3897 of 03/12/2001
12/03/2002 Centralised - Annual reassessment EMEA/H/C/102/S/29 (2002)1021 of 08/03/2002
13/05/2002 Centralised - Variation EMEA/H/C/102/II/22 (2002)1893 of 07/05/2002
13/05/2002 Centralised - Renewal EMEA/H/C/102/R/30 (2002)1896 of 07/05/2002
31/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/32
08/08/2002 Centralised - Notification EMEA/H/C/102/N/33 (2002)3085 of 06/08/2002
14/01/2003 Centralised - Annual reassessment EMEA/H/C/102/S/34 (2003)263 of 10/01/2003
03/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/35
26/06/2003 Centralised - Variation EMEA/H/C/102/X/31 (2003)2035 of 24/06/2003
01/08/2003 Centralised - Variation EMEA/H/C/102/II/36 (2003)2843 of 30/07/2003
10/10/2003 Centralised - Variation EMEA/H/C/102/I/37 (2003)3725 of 08/10/2003
15/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/40
14/11/2003 Centralised - Variation EMEA/H/C/102/X/28 (2003)4303 of 12/11/2003
14/01/2004 Centralised - Annual reassessment EMEA/H/C/102/S/38 (2004)66 of 12/01/2004
15/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/44
15/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/43
15/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/41
03/02/2004 Centralised - Variation EMEA/H/C/102/II/39 (2004)300 of 30/01/2004
07/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/47
21/06/2004 Centralised - Notification EMEA/H/C/102/N/51
Updated with Decision(2004)3651 of 27/09/2004
02/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/49
04/08/2004 Centralised - Variation EMEA/H/C/102/IA/46
Updated with Decision(2004)3651 of 27/09/2004
22/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/50
30/09/2004 Centralised - Variation EMEA/H/C/102/II/45 (2004)3651 of 27/09/2004
22/10/2004 Centralised - Annual reassessment EMEA/H/C/102/S/52
10/11/2004 Centralised - Variation EMEA/H/C/102/IA/54
Updated with Decision(2005)384 of 14/02/2005
23/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/53
29/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/55
15/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/57
16/02/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/102/T/56 (2005)384 of 14/02/2005
01/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/58
24/06/2005 Centralised - Notification EMEA/H/C/102/N/64
Updated with Decision(2005)3397 of 31/08/2005
29/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/60
10/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/62
02/09/2005 Centralised - Variation EMEA/H/C/102/II/61 (2005)3396 of 31/08/2005
02/09/2005 Centralised - Variation EMEA/H/C/102/II/59 (2005)3397 of 31/08/2005
11/09/2005 Centralised - Notification EMEA/H/C/102/N/67
Updated with Decision(2006)1040 of 22/03/2006
26/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/65
26/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/63
15/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IB/69
02/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IB/72
06/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/70
24/03/2006 Centralised - Annual reassessment EMEA/H/C/102/S/66 (2006)1040 of 22/03/2006
04/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/76
04/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/74
16/08/2006 Centralised - Notification EMEA/H/C/102/N/75
Updated with Decision(2006)4127 of 07/09/2006
31/08/2006 Centralised - Variation EMEA/H/C/102/IA/80
Updated with Decision(2006)5117 of 20/10/2006
12/09/2006 Centralised - Variation EMEA/H/C/102/II/77 (2006)4127 of 07/09/2006
24/10/2006 Centralised - Variation EMEA/H/C/102/II/78 (2006)5117 of 20/10/2006
04/01/2007 Centralised - Variation EMEA/H/C/102/IB/83
Updated with Decision(2007)3400 of 09/07/2007
02/02/2007 Centralised - Variation EMEA/H/C/102/II/82 (2007)368 of 31/01/2007
23/02/2007 Centralised - Renewal EMEA/H/C/102/R/81 (2007)626 of 21/02/2007
25/04/2007 Centralised - Notification EMEA/H/C/102/N/88
Updated with Decision(2007)3400 of 09/07/2007
03/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/87
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/I/A89
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/90
21/06/2007 Centralised - Variation EMEA/H/C/102/IA/93
Updated with Decision(2007)3400 of 09/07/2007
11/07/2007 Centralised - Variation (2007)3400 of 09/07/2007
30/07/2007 Centralised - Notification EMEA/H/C/102/N/92
Updated with Decision(2008)899 of 03/03/2008
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/91
10/08/2007 Centralised - Notification EMEA/H/C/102/N/94
Updated with Decision(2008)899 of 03/03/2008
14/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/95
05/03/2008 Centralised - Variation EMEA/H/C/102/II/96 (2008)899 of 03/03/2008
30/04/2008 Centralised - Variation EMEA/H/C/102/IB/99
Updated with Decision(2008)7610 of 25/11/2008
24/06/2008 Centralised - Variation EMEA/H/C/102/II/98 (2008)3196 of 20/06/2008
30/06/2008 Centralised - Variation EMEA/H/C/102/IA/101
Updated with Decision(2008)7610 of 25/11/2008
02/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/12
08/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IB/100
24/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/104
27/11/2008 Centralised - Variation (2008)7610 of 25/11/2008
22/12/2008 Centralised - Variation EMEA/H/C/102/II/103 (2008)8808 of 17/12/2008
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/106
17/03/2010 Centralised - Variation EMEA/H/C/102/II/108 (2010)1809 of 15/03/2010
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/II/109/G
11/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/102/IA/111
19/05/2011 Centralised - Variation EMEA/H/C/102/IA/114
Updated with Decision(2011)7783 of 24/10/2011
01/06/2011 Centralised - Variation EMEA/H/C/102/II/110/G (2011)3873 of 27/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/102/II/115 (2011)7783 of 24/10/2011
15/12/2011 Centralised - Notification EMEA/H/C/102/N/22
Updated with Decision(2012)5277 of 20/07/2012
24/07/2012 Centralised - Variation EMEA/H/C/102/II/125 (2012)5277 of 20/07/2012
29/10/2012 Centralised - Notification EMEA/H/C/102/N/133
Updated with Decision(2014)6172 of 26/08/2014
07/08/2013 Centralised - Notification EMEA/H/C/102/N/137
Updated with Decision(2014)6172 of 26/08/2014
25/04/2014 Centralised - Variation EMEA/H/C/102/II/141
Updated with Decision(2014)6172 of 26/08/2014
09/05/2014 Centralised - Variation EMEA/H/C/102/IB/142
Updated with Decision(2014)6172 of 26/08/2014
28/08/2014 Centralised - 2-Monthly update EMEA/H/C/102/II/143 (2014)6172 of 26/08/2014