Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mabthera   
Auth. number : EU/1/98/067
INN : Rituximab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC02 - Rituximab
(See WHO ATC Index)
Indication: Mabthera is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Mabthera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Mabthera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Mabthera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Mabthera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Chronic lymphocytic leukaemia (CLL)
Mabthera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
Rheumatoid arthritis
Mabthera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Mabthera has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.
Granulomatosis with polyangiitis and Microscopic polyangiitis
Mabthera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active Granulomatosis with polyangiitis (Wegener’s) (GPA) and Microscopic polyangiitis (MPA).
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
03/06/1998 Centralised - Authorisation EMEA/H/C/165 (1998)1464 of 02/06/1998
30/06/1999 Centralised - Variation EMEA/H/C/165/II/2 (1999)1653 of 18/06/1999
14/09/1999 Centralised - Variation EMEA/H/C/165/II/3 (1999)2873 of 09/09/1999
10/02/2000 Centralised - Variation EMEA/H/C/165/II/5 (2000)177 of 08/02/2000
08/05/2000 Centralised - Notification EMEA/H/C/165/N/8 (2000)1185 of 03/05/2000
24/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/7
24/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/6
24/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/9
24/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/10
27/06/2001 Centralised - Variation EMEA/H/C/165/II/12 (2001)1361 of 27/06/2001
04/10/2001 Centralised - Notification EMEA/H/C/165/N/13 (2001)2765 of 03/10/2001
21/02/2002 Centralised - Variation EMEA/H/C/165/I/15 (2002)650 of 19/02/2002
25/03/2002 Centralised - Variation EMEA/H/C/165/II/14 (2002)1269 of 21/03/2002
03/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/11
17/07/2002 Centralised - Variation EMEA/H/C/165/II/16 (2002)2793 of 15/07/2002
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/18, 21
25/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/22
01/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/23
30/07/2003 Centralised - Renewal EMEA/H/C/165/R/17 (2003)2824 of 28/07/2003
26/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/I/26
16/01/2004 Centralised - Variation EMEA/H/C/165/II/25 (2004)84 of 14/01/2004
05/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/27
23/03/2004 Centralised - Variation EMEA/H/C/165/II/28 (2004)1046 of 19/03/2004
11/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/30
02/07/2004 Centralised - Notification EMEA/H/C/165/N/32
Updated with Decision(2004)3054 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/165/II/31 (2004)3054 of 02/08/2004
09/03/2005 Centralised - Variation EMEA/H/C/165/II/33 (2005)662 of 07/03/2005
22/04/2005 Centralised - Variation EMEA/H/C/165/IA/36
Updated with Decision(2005)4503 of 15/11/2005
29/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IA/38
27/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IB/37
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/34, 35
17/10/2005 Centralised - Variation EMEA/H/C/165/IA/42
Updated with Decision(2005)4503 of 15/11/2005
18/11/2005 Centralised - Variation (2005)4503 of 15/11/2005
22/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/41
22/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/40
24/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IA/45
22/03/2006 Centralised - Variation EMEA/H/C/165/II/43 (2006)962 of 20/03/2006
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/46
10/07/2006 Centralised - Variation EMEA/H/C/165/II/39, 44 (2006)3177 of 06/07/2006
13/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IA/47
13/10/2006 Centralised - Variation EMEA/H/C/165/IA/49
Updated with Decision(2007)155 of 12/01/2007
16/01/2007 Centralised - Variation EMEA/H/C/165/II/51 (2007)155 of 12/01/2007
29/03/2007 Centralised - Variation EMEA/H/C/165/II/48 (2007)1491 of 27/03/2007
31/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/50
06/09/2007 Centralised - Variation EMEA/H/C/165/II/52 (2007)4192 of 03/09/2007
23/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/54
21/11/2007 Centralised - Variation EMEA/H/C/165/II/55 (2007)5658 of 19/11/2007
22/01/2008 Centralised - Variation EMEA/H/C/165/II/53 (2008)308 of 18/01/2008
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/56
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/II/57
22/05/2008 Centralised - Renewal EMEA/H/C/165/R/58 (2008)2157 of 20/05/2008
08/07/2008 Centralised - Variation EMEA/H/C/165/II/59 (2008)3536 of 04/07/2008
26/11/2008 Centralised - Variation EMEA/H/C/165/II/62 (2008)7497 of 24/11/2008
25/02/2009 Centralised - Variation EMEA/H/C/165/II/60 (2009)1314 of 23/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/165/II/63 (2009)2292 of 25/03/2009
25/08/2009 Centralised - Variation EMEA/H/C/165/II/64 (2009)6619 of 21/08/2009
10/09/2009 Centralised - Variation EMEA/H/C/165/IA/66
Updated with Decision(2010)1999 of 23/03/2010
11/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IA/67
25/03/2010 Centralised - Variation EMEA/H/C/165/II/68 (2010)1999 of 23/03/2010
27/10/2010 Centralised - Variation EMEA/H/C/165/II/65, 69 (2010)7549 of 25/10/2010
19/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/165/IB/71
23/12/2010 Centralised - Variation EMEA/H/C/165/II/70/G (2010)9614 of 20/12/2010
27/06/2011 Centralised - Variation EMEA/H/C/165/II/72 (2011)4622 of 23/06/2011
19/12/2011 Centralised - Variation EMEA/H/C/165/II/76 (2011)9754 of 14/12/2011
19/12/2011 Centralised - Variation EMEA/H/C/165/IB/75
Updated with Decision(2011)9754 of 14/12/2011
30/05/2012 Centralised - Variation EMEA/H/C/165/II/77/G (2012)3558 of 25/05/2012
07/08/2012 Referral EMEA/H/C/165/A-20/78 (2012)5684 of 03/08/2012
21/02/2013 Centralised - Variation EMEA/H/C/165/II/80/G
Updated with Decision(2013)2401 of 22/04/2013
21/03/2013 Centralised - Variation EMEA/H/C/165/II/79
Updated with Decision(2013)2401 of 22/04/2013
24/04/2013 Centralised - 2-Monthly update EMEA/H/C/165/II/84 (2013)2401 of 22/04/2013
27/06/2013 Centralised - Variation EMEA/H/C/165/II/85
Updated with Decision(2013)8334 of 20/11/2013
10/07/2013 Centralised - Variation EMEA/H/C/165/IA/86
Updated with Decision(2013)8334 of 20/11/2013
25/11/2013 Centralised - 2-Monthly update EMEA/H/C/165/II/87 (2013)8334 of 20/11/2013
26/03/2014 Centralised - Variation EMEA/H/C/165/X/83 (2014)2048 of 21/03/2014
25/04/2014 Centralised - Variation EMEA/H/C/165/II/92
Updated with Decision(2014)3622 of 23/05/2014
25/04/2014 Centralised - Variation EMEA/H/C/165/II/90
Updated with Decision(2014)3622 of 23/05/2014
27/05/2014 Centralised - 2-Monthly update EMEA/H/C/165/II/89 (2014)3622 of 23/05/2014
25/09/2014 Centralised - Variation EMEA/H/C/165/II/97