Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rebif   
Auth. number : EU/1/98/063
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: Rebif is indicated for the treatment of relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.
Marketing Authorisation Holder: Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, 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
05/05/1998 Centralised - Authorisation EMEA/H/C/136 (1998)1164 of 04/05/1998
02/04/1999 Centralised - Variation EMEA/H/C/136/II/2 (1999)193 of 01/02/1999
08/04/1999 Centralised - Authorisation EMEA/H/C/136 (1999)838 of 29/03/1999
07/12/1999 Centralised - Annual reassessment EMEA/H/C/136/S/3 (1999)4138 of 03/12/1999
15/12/1999 Centralised - Variation EMEA/H/C/136/II/8 (1999)4364 of 14/12/1999
25/01/2000 Centralised - Variation EMEA/H/C/136/I/10 (2000)112 of 20/01/2000
11/04/2000 Centralised - Variation EMEA/H/C/136/I/12
12/09/2000 Centralised - Variation EMEA/H/C/136/I/18
13/10/2000 Centralised - Variation EMEA/H/C/136/II/17
16/10/2000 Centralised - Variation EMEA/H/C/136/I/16
11/12/2000 Centralised - Annual reassessment EMEA/H/C/136/S/14 (2000)3501 of 08/12/2000
20/12/2000 Centralised - Variation EMEA/H/C/136/I/19
24/01/2001 Centralised - Variation EMEA/H/C/136/II/13 (2001)82 of 22/01/2001
13/03/2001 Centralised - Variation EMEA/H/C/136/I/18
29/03/2001 Centralised - Variation EMEA/H/C/136/I/15 (2001)567 of 20/03/2001
20/07/2001 Centralised - Variation EMEA/H/C/136/I/21 (2001)2027 of 19/07/2001
07/09/2001 Centralised - Variation EMEA/H/C/136/I/25
07/09/2001 Centralised - Variation EMEA/H/C/136/I/27
21/09/2001 Centralised - Variation EMEA/H/C/136/I/26 (2001)2711 of 18/09/2001
04/10/2001 Centralised - Variation EMEA/H/C/136/N/24 (2001)2767 of 03/10/2001
08/10/2001 Centralised - Variation EMEA/H/C/136/I/28
23/11/2001 Centralised - Variation EMEA/H/C/136/II/11 (2001)3591 of 21/11/2001
28/11/2001 Centralised - Variation EMEA/H/C/136/II/29
11/02/2002 Centralised - Variation EMEA/H/C/136/I/31
04/04/2002 Centralised - Variation EMEA/H/C/136/N/32 (2002)1388 of 02/04/2002
22/05/2002 Centralised - Variation EMEA/H/C/136/II/30 (2002)1954 of 17/05/2002
31/07/2002 Centralised - Variation EMEA/H/C/136/I/33
31/07/2002 Centralised - Variation EMEA/H/C/136/I/34
10/09/2002 Centralised - Variation EMEA/H/C/136/I/36
10/09/2002 Centralised - Variation EMEA/H/C/136/I/35
16/12/2002 Centralised - Variation EMEA/H/C/136/I/37
20/01/2003 Centralised - Variation EMEA/H/C/136/X/22 (2003)331 of 16/01/2003
06/03/2003 Centralised - Variation EMEA/H/C/136/N/39 (2003)754 of 04/03/2003
27/05/2003 Centralised - Variation EMEA/H/C/136/II/42
06/06/2003 Centralised - Renewal EMEA/H/C/136/R/40 (2003)1836 of 04/06/2003
27/06/2003 Centralised - Variation EMEA/H/C/136/II/38 (2003)2078 of 25/06/2003
18/09/2003 Centralised - Variation EMEA/H/C/136/I/43
22/10/2003 Centralised - Variation EMEA/H/C/136/I/48
30/10/2003 Centralised - Variation EMEA/H/C/136/II/44
01/12/2003 Centralised - Variation EMEA/H/C/136/I/45
02/12/2003 Centralised - Variation EMEA/H/C/136/I/46
26/02/2004 Centralised - Variation EMEA/H/C/136/II/49 (2004)630 of 23/02/2004
23/07/2004 Centralised - Variation EMEA/H/C/136/II/47 (2004)2898 of 20/07/2004
22/11/2004 Centralised - Variation EMEA/H/C/136/N/56
Updated with Decision(2006)127 of 19/01/2006
24/01/2006 Centralised - Variation EMEA/H/C/136/X/51 (2006)127 of 19/01/2006
02/06/2006 Centralised - Variation EMEA/H/C/136/II/52 (2006)2227 of 31/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/136/N/53
Updated with Decision(2006)4052 of 01/09/2006
07/09/2006 Centralised - Variation EMEA/H/C/136/II/56, 57 (2006)4052 of 01/09/2006
30/03/2007 Centralised - Variation EMEA/H/C/136/II/59 (2007)1513 of 28/03/2007
14/08/2007 Centralised - Variation EMEA/H/C/136/II/54 (2007)3923 of 10/08/2007
18/12/2007 Centralised - Variation EMEA/H/C/136/II/60 (2007)6679 of 14/12/2007
27/05/2008 Centralised - Renewal EMEA/H/C/136/R/61 (2008)2024 of 20/05/2008
28/05/2008 Centralised - Variation EMEA/H/C/136/IA/62
05/06/2008 Centralised - Variation EMEA/H/C/136/IA/63
22/10/2008 Centralised - Variation EMEA/H/C/136/IA/68
Updated with Decision(2009)234 of 16/01/2009
20/01/2009 Centralised - Variation EMEA/H/C/136/X/64 (2009)234 of 16/01/2009
10/03/2009 Centralised - Variation EMEA/H/C/136/IA/71
Updated with Decision(2009)3187 of 22/04/2009
24/04/2009 Centralised - Variation EMEA/H/C/136/II/70 (2009)3187 of 22/04/2009
03/07/2009 Centralised - Variation EMEA/H/C/136/II/72 (2009)5405 of 01/07/2009
24/07/2009 Centralised - Variation EMEA/H/C/136/IA/75
Updated with Decision(2009)8404 of 23/10/2009
29/07/2009 Centralised - Variation EMEA/H/C/136/N/73
Updated with Decision(2009)8404 of 23/10/2009
16/09/2009 Centralised - Variation EMEA/H/C/136/N/76
Updated with Decision(2009)8404 of 23/10/2009
27/10/2009 Centralised - Variation EMEA/H/C/136/II/74 (2009)8404 of 23/10/2009
02/02/2010 Centralised - Variation EMEA/H/C/136/II/77
02/02/2010 Centralised - Variation EMEA/H/C/136/II/78
31/03/2010 Centralised - Variation EMEA/H/C/136/N/83
Updated with Decision(2010)3647 of 02/06/2010
04/06/2010 Centralised - Variation EMEA/H/C/136/II/79, 80, 82 (2010)3647 of 02/06/2010
10/08/2010 Centralised - Variation EMEA/H/C/136/II/81 (2010)5595 of 06/08/2010
28/02/2011 Centralised - Variation EMEA/H/C/136/II/85/G
07/05/2011 Centralised - Variation EMEA/H/C/136/N/86
Updated with Decision(2012)423 of 20/01/2012
08/08/2011 Centralised - Variation EMEA/H/C/136/IB/87
Updated with Decision(2012)423 of 20/01/2012
25/01/2012 Centralised - Variation EMEA/H/C/136/II/88/G (2012)423 of 20/01/2012
29/06/2012 Centralised - Variation EMEA/H/C/136/II/91 (2012)4479 of 27/06/2012
21/02/2013 Centralised - Variation EMEA/H/C/136/II/93
Updated with Decision(2014)1471 of 28/02/2014
09/10/2013 Centralised - Variation EMEA/H/C/136/N/102
Updated with Decision(2014)1471 of 28/02/2014
18/12/2013 Centralised - Variation EMEA/H/C/136/II/103
Updated with Decision(2014)1471 of 28/02/2014
04/03/2014 Centralised - Variation (2014)1471 of 28/02/2014
25/04/2014 Centralised - Variation EMEA/H/C/136/II/105
25/04/2014 Centralised - Variation EMEA/H/C/136/II/104