Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Betaferon   
Auth. number : EU/1/95/003
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: Betaferon 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 (see section 5.1).- 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: Bayer Pharma AG
D-13342 Berlin, Deutschland

  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
06/12/1995 Centralised - Authorisation EMEA/H/C/81 (95)2955 of 30/11/1995
22/11/1996 Centralised - Authorisation EMEA/H/C/81/II/1 (96)3372 of 21/11/1996
04/04/1997 Centralised - Variation EMEA/H/C/81/II/3 (97)923 of 02/04/1997
23/05/1997 Centralised - Variation EMEA/H/C/81/I/7 (97)1428 of 22/05/1997
23/05/1997 Centralised - Variation EMEA/H/C/81/I/6 (97)1428 of 22/05/1997
10/07/1997 Centralised - Annual reassessment EMEA/H/C/81/RA/ (97)2144 of 09/07/1997
10/02/1998 Centralised - Variation EMEA/H/C/81/II/9 (1998)252 of 05/02/1998
10/07/1998 Centralised - Annual reassessment EMEA/H/C/81/RA/2 (1998)1865 of 08/07/1998
16/11/1998 Centralised - Variation EMEA/H/C/81/II/13 (1998)3498 of 11/11/1998
28/01/1999 Centralised - Variation EMEA/H/C/81/II/14 (1999)152 of 26/01/1999
31/05/1999 Centralised - Annual reassessment EMEA/H/C/81/S/16 (1999)1292 of 11/05/1999
17/09/1999 Centralised - Variation EMEA/H/C/81/II/18 (1999)2963 of 14/09/1999
09/02/2000 Centralised - Authorisation EMEA/H/C/81/X/17 (2000)173 of 03/02/2000
15/05/2000 Centralised - Annual reassessment EMEA/H/C/81/S/19 (2000)1199 of 11/05/2000
29/05/2000 Centralised - Variation EMEA/H/C/81/I/20
02/08/2000 Centralised - Variation EMEA/H/C/81/II/21
30/01/2001 Centralised - Variation EMEA/H/C/81/II/22 (2001)97 of 29/01/2001
05/04/2001 Centralised - Renewal EMEA/H/C/81/R/23, 24 (2001)826 of 03/04/2001
06/04/2001 Centralised - Variation EMEA/H/C/81/I/26
02/10/2001 Centralised - Variation EMEA/H/C/81/I/27
20/11/2001 Centralised - Variation EMEA/H/C/81/II/25 (2001)3557 of 19/11/2001
13/01/2003 Centralised - Variation EMEA/H/C/81/I/28 (2003)260 of 09/01/2003
28/07/2003 Centralised - Variation EMEA/H/C/81/II/29
24/11/2003 Centralised - Variation EMEA/H/C/81/II/30
14/07/2004 Centralised - Variation EMEA/H/C/81/II/32 (2004)2785 of 12/07/2004
02/08/2004 Centralised - Variation EMEA/H/C/81/II/33
14/06/2005 Centralised - Variation EMEA/H/C/81/N/34
Updated with Decision(2005)4295 of 27/10/2005
31/10/2005 Centralised - Variation EMEA/H/C/81/II/34 (2005)4295 of 27/10/2005
02/02/2006 Centralised - Renewal EMEA/H/C/81/R/37 (2006)300 of 31/01/2006
06/06/2006 Centralised - Variation EMEA/H/C/81/II/36, 38 (2006)2250 of 01/06/2006
06/09/2006 Centralised - Variation EMEA/H/C/81/II/40 (2006)4060 of 01/09/2006
12/02/2007 Centralised - Variation EMEA/H/C/81/N/42
Updated with Decision(2007)1536 of 29/03/2007
28/03/2007 Centralised - Variation EMEA/H/C/81/IA/44
Updated with Decision(2007)5554 of 13/11/2007
02/04/2007 Centralised - Variation EMEA/H/C/81/II/41 (2007)1536 of 29/03/2007
21/06/2007 Centralised - Variation EMEA/H/C/81/IA/47
11/09/2007 Corrigendum EMEA/H/C/81/II/40 (2006)4060 corr of 04/09/2007
05/10/2007 Centralised - Variation EMEA/H/C/81/N/49
Updated with Decision(2007)6755 of 18/12/2007
05/11/2007 Centralised - Variation EMEA/H/C/81/IA/52
Updated with Decision(2007)6755 of 18/12/2007
15/11/2007 Centralised - Variation (2007)5554 of 13/11/2007
21/11/2007 Centralised - Variation EMEA/H/C/81/II/45
20/12/2007 Centralised - Variation EMEA/H/C/81/II/48 (2007)6755 of 18/12/2007
04/07/2008 Centralised - Variation EMEA/H/C/81/IA/58
07/07/2008 Centralised - Variation EMEA/H/C/81/IA/56
Updated with Decision(2008)6533 of 29/10/2008
01/08/2008 Centralised - Variation EMEA/H/C/81/IB/59
Updated with Decision(2008)6533 of 29/10/2008
02/10/2008 Centralised - Variation EMEA/H/C/81/II/54
31/10/2008 Centralised - Variation EMEA/H/C/81/II/55 (2008)6533 of 29/10/2008
10/02/2009 Centralised - Variation EMEA/H/C/81/IA/61
Updated with Decision(2009)6747 of 31/08/2009
17/02/2009 Centralised - Variation EMEA/H/C/81/IA/62
Updated with Decision(2009)6747 of 31/08/2009
04/03/2009 Centralised - Variation EMEA/H/C/81/II/60
02/09/2009 Centralised - Variation (2009)6747 of 31/08/2009
16/11/2009 Centralised - Variation EMEA/H/C/81/IA/65
Updated with Decision(2010)525 of 25/01/2010
27/01/2010 Centralised - Variation EMEA/H/C/81/II/64 (2010)525 of 25/01/2010
07/04/2010 Centralised - Variation EMEA/H/C/81/IA/66
28/07/2010 Centralised - Variation EMEA/H/C/81/IA/69
13/10/2010 Centralised - Variation EMEA/H/C/81/IA/70/G
14/12/2010 Centralised - Variation EMEA/H/C/81/N/71
Updated with Decision(2011)5385 of 20/07/2011
12/01/2011 Centralised - Variation EMEA/H/C/81/IA/72/G
Updated with Decision(2011)5385 of 20/07/2011
04/02/2011 Centralised - Variation EMEA/H/C/81/II/68/G
04/02/2011 Centralised - Variation EMEA/H/C/81/II/67/G
16/03/2011 Centralised - Variation EMEA/H/C/81/IA/73
25/07/2011 Centralised - Variation (2011)5385 of 20/07/2011
24/08/2011 Centralised - Variation EMEA/H/C/81/IA/81/G
Updated with Decision(2012)3567 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/81/II/78 (2012)3567 of 25/05/2012
27/03/2014 Centralised - Variation EMEA/H/C/81/N/93
25/04/2014 Centralised - Variation EMEA/H/C/81/II/91