Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: MabCampath
Auth. number : EU/1/01/193
INN : Alemtuzumab
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: L01XC04 - Alemtuzumab
(See WHO ATC Index)
Indication: MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland

  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
10/07/2001 Centralised - Authorisation EMEA/H/C/353 (2001)1392 of 06/07/2001
01/05/2002 Centralised - Variation EMEA/H/C/353/I/1 (2002)1823 of 29/04/2002
12/11/2002 Centralised - Notification EMEA/H/C/353/N/2 (2002)4433 of 07/11/2002
24/12/2002 Centralised - Annual reassessment EMEA/H/C/353/S/3 (2002)5433 of 18/12/2002
27/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/I/6
13/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/I/8
10/04/2003 Centralised - Notification EMEA/H/C/353/N/4 (2003)1246 of 08/04/2003
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/I/5
27/06/2003 Centralised - Variation EMEA/H/C/353/II/7 (2003)2085 of 25/06/2003
09/12/2003 Centralised - Variation EMEA/H/C/353/II/10 (2003)4691 of 04/12/2003
14/01/2004 Centralised - Annual reassessment EMEA/H/C/353/S/12 (2004)58 of 09/01/2004
22/01/2004 Centralised - Variation EMEA/H/C/353/II/11 (2004)140 of 20/01/2004
21/09/2004 Centralised - Annual reassessment EMEA/H/C/353/S/14
05/11/2004 Centralised - Variation EMEA/H/C/353/X/13 (2004)4327 of 29/10/2004
18/02/2005 Centralised - Variation EMEA/H/C/353/IB/16
Updated with Decision(2005)3224 of 16/08/2005
27/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/17
18/08/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/353/T/18 (2005)3224 of 16/08/2005
23/01/2006 Corrigendum EMEA/H/C/353/T/18
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/21
08/06/2006 Centralised - Notification EMEA/H/C/353/N/20
Updated with Decision(2006)3562 of 28/07/2006
03/08/2006 Centralised - Renewal EMEA/H/C/353/R/22 (2006)3562 of 28/07/2006
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/26
26/03/2007 Centralised - Annual reassessment EMEA/H/C/353/S/27
24/04/2007 Centralised - Variation EMEA/H/C/353/IA/33
Updated with Decision(2007)6771 of 19/12/2007
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/IB/31
23/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/28
20/12/2007 Centralised - Variation EMEA/H/C/353/II/30 (2007)6770 of 19/12/2007
21/12/2007 Centralised - Variation EMEA/H/C/353/II/30 (2007)6771 of 19/12/2007
18/02/2008 Centralised - Notification EMEA/H/C/353/N/34
Updated with Decision(2008)3502 of 04/07/2008
05/03/2008 Centralised - Notification EMEA/H/C/353/N/36
Updated with Decision(2008)3502 of 04/07/2008
07/03/2008 Corrigendum EMEA/H/C/353/II/30
07/03/2008 Corrigendum EMEA/H/C/353/II/30
09/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/IA/38
04/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/IB/39
08/07/2008 Centralised - Annual reassessment EMEA/H/C/353/S/35 (2008)3502 of 04/07/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/37
09/12/2008 Centralised - Variation EMEA/H/C/353/II/40 (2008)8245 of 05/12/2008
12/05/2009 Centralised - Notification EMEA/H/C/353/N/42
Updated with Decision(2009)9336 of 20/11/2009
25/06/2009 Centralised - Variation EMEA/H/C/353/IA/44
Updated with Decision(2009)9336 of 20/11/2009
25/06/2009 Centralised - Variation EMEA/H/C/353/IA/45
Updated with Decision(2009)9336 of 20/11/2009
13/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/IA/46
28/07/2009 Centralised - Notification EMEA/H/C/353/N/43
Updated with Decision(2009)9336 of 20/11/2009
20/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/IA/51
24/11/2009 Centralised - Variation EMEA/H/C/353/II/48 (2009)9336 of 20/11/2009
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/47
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/49
11/12/2009 Centralised - Notification EMEA/H/C/353/N/50
Updated with Decision(2011)3444 of 12/05/2011
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/52
05/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/353/II/53
16/05/2011 Centralised - Renewal EMEA/H/C/353/R/54 (2011)3444 of 12/05/2011
20/06/2012 Centralised - Notification EMEA/H/C/353/N/55
10/08/2012 Centralised - Withdrawal (2012)5761 of 08/08/2012