Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: CellCept   
Auth. number : EU/1/96/005
INN : Mycophenolate mofetil
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA06 - Mycophenolic acid
(See WHO ATC Index)
Indication: CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
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
15/02/1996 Centralised - Authorisation EMEA/H/C/82 (96)355 of 14/02/1996
06/05/1997 Centralised - Variation EMEA/H/C/82/I/3 (97)1280 of 02/05/1997
14/05/1997 Centralised - Authorisation EMEA/H/C/82/II/2 (97)1329 of 13/05/1997
15/07/1997 Centralised - Variation EMEA/H/C/82/I/5 (97)2185 of 14/07/1997
18/08/1998 Centralised - Variation EMEA/H/C/82/II/10 (1998)2185 of 17/08/1998
22/09/1998 Centralised - Variation EMEA/H/C/82/II/20 (1998)2696 of 18/09/1998
23/10/1998 Centralised - Authorisation EMEA/H/C/82/X/13 (1998)3183 of 20/10/1998
24/12/1998 Centralised - Variation EMEA/H/C/82/I/19 (1998)4499 of 17/12/1998
05/03/1999 Centralised - Authorisation EMEA/H/C/82/X/14 (1999)454 of 26/02/1999
15/12/1999 Centralised - Variation EMEA/H/C/82/II/22 (1999)4185 of 08/12/1999
30/03/2000 Centralised - Variation EMEA/H/C/82/I/25
06/07/2000 Centralised - Variation EMEA/H/C/82/II/26
13/11/2000 Centralised - Variation EMEA/H/C/82/II/24 (2000)3200 of 09/11/2000
30/04/2001 Centralised - Variation EMEA/H/C/82/II/31 (2001)871 of 27/04/2001
04/05/2001 Centralised - Variation EMEA/H/C/82/II/29
08/05/2001 Centralised - Renewal EMEA/H/C/82/R/30 (2001)913 of 03/05/2001
23/05/2001 Centralised - Variation EMEA/H/C/82/I/33
17/07/2001 Centralised - Variation EMEA/H/C/82/II/27 (2001)2018 of 16/07/2001
17/07/2001 Centralised - Variation EMEA/H/C/82/II/32 (2001)2017 of 16/07/2001
14/11/2001 Centralised - Variation EMEA/H/C/82/N/35 (2001)3527 of 12/11/2001
28/11/2001 Centralised - Variation EMEA/H/C/82/I/38, 40, 45
28/11/2001 Centralised - Variation EMEA/H/C/82/I/47
28/11/2001 Centralised - Variation EMEA/H/C/82/I/41, 44
10/12/2001 Centralised - Variation EMEA/H/C/82/I/48, 49
10/12/2001 Centralised - Variation EMEA/H/C/82/II/34 (2001)4044 of 06/12/2001
10/12/2001 Centralised - Variation EMEA/H/C/82/I/50
21/12/2001 Centralised - Variation EMEA/H/C/82/II/37
08/02/2002 Centralised - Variation EMEA/H/C/82/I/39 (2002)485 of 06/02/2002
08/02/2002 Centralised - Variation EMEA/H/C/82/I/46 (2002)481 of 05/02/2002
13/02/2002 Centralised - Variation EMEA/H/C/82/I/51
17/05/2002 Centralised - Variation EMEA/H/C/82/II/36 (2002)1936 of 15/05/2002
10/09/2002 Centralised - Variation EMEA/H/C/82/I/54
10/09/2002 Centralised - Variation EMEA/H/C/82/I/53
10/09/2002 Centralised - Variation EMEA/H/C/82/I/56
22/10/2002 Centralised - Variation EMEA/H/C/82/II/55 (2002)4083 of 18/10/2002
04/12/2002 Centralised - Variation EMEA/H/C/82/I/57 (2002)4901 of 02/12/2002
28/07/2003 Centralised - Variation EMEA/H/C/82/II/58
29/06/2004 Centralised - Variation EMEA/H/C/82/IA/60
29/06/2004 Centralised - Variation EMEA/H/C/82/IA/61
29/07/2004 Centralised - Variation EMEA/H/C/82/IB/62
29/07/2004 Centralised - Variation EMEA/H/C/82/IB/63
04/08/2004 Centralised - Variation EMEA/H/C/82/II/59 (2004)3050 of 02/08/2004
27/09/2004 Centralised - Variation EMEA/H/C/82/IB/64
29/04/2005 Centralised - Variation EMEA/H/C/82/II/65 (2005)1392 of 27/04/2005
12/09/2005 Centralised - Variation EMEA/H/C/82/IA/67
11/10/2005 Centralised - Variation EMEA/H/C/82/IA/68
Updated with Decision(2005)4486 of 15/11/2005
18/11/2005 Centralised - Variation EMEA/H/C/82/II/66 (2005)4486 of 15/11/2005
15/03/2006 Centralised - Renewal EMEA/H/C/82/R/69 (2006)847 of 13/03/2006
05/05/2006 Centralised - Variation EMEA/H/C/82/IB/70
27/11/2006 Centralised - Variation EMEA/H/C/82/IB/73
27/11/2006 Centralised - Variation EMEA/H/C/82/IB/72
27/11/2006 Centralised - Variation EMEA/H/C/82/IB/74
15/12/2006 Centralised - Variation EMEA/H/C/82/IA/75
Updated with Decision(2007)3301 of 02/07/2007
22/03/2007 Centralised - Variation EMEA/H/C/82/IB/78
16/04/2007 Centralised - Variation EMEA/H/C/82/N/76
Updated with Decision(2007)3301 of 02/07/2007
11/05/2007 Centralised - Variation EMEA/H/C/82/IB/80
05/07/2007 Centralised - Variation (2007)3301 of 02/07/2007
14/08/2007 Centralised - Variation EMEA/H/C/82/II/77 (2007)3922 of 10/08/2007
05/10/2007 Centralised - Variation EMEA/H/C/82/IA/81
23/10/2007 Centralised - Variation EMEA/H/C/82/II/79 (2007)5232 of 19/10/2007
03/03/2008 Centralised - Variation EMEA/H/C/82/II/82, 83 (2008)843 of 28/02/2008
27/10/2008 Centralised - Variation EMEA/H/C/82/II/84 (2008)6307 of 23/10/2008
10/11/2008 Centralised - Variation EMEA/H/C/82/IA/85
22/04/2009 Centralised - Variation EMEA/H/C/82/IA/89
23/04/2009 Centralised - Variation EMEA/H/C/82/IA/91
27/04/2009 Centralised - Variation EMEA/H/C/82/IA/90
29/04/2009 Centralised - Variation EMEA/H/C/82/IB/92
06/05/2009 Centralised - Variation EMEA/H/C/82/IB/88
06/05/2009 Centralised - Variation EMEA/H/C/82/IB/87
03/06/2009 Centralised - Variation EMEA/H/C/82/II/86 (2009)4344 of 29/05/2009
29/09/2009 Centralised - Variation EMEA/H/C/82/IA/94
29/09/2009 Centralised - Variation EMEA/H/C/82/IA/96
29/09/2009 Centralised - Variation EMEA/H/C/82/IA/95
15/10/2009 Centralised - Variation EMEA/H/C/82/II/93 (2009)7962 of 13/10/2009
21/01/2010 Centralised - Variation EMEA/H/C/82/IB/98
23/02/2010 Centralised - Variation EMEA/H/C/82/II/97
15/09/2010 Centralised - Variation EMEA/H/C/82/IA/99/G
20/10/2010 Centralised - Variation EMEA/H/C/82/IB/100
Updated with Decision(2011)3876 of 27/05/2011
08/12/2010 Centralised - Variation EMEA/H/C/82/IA/101/G
04/03/2011 Centralised - Variation EMEA/H/C/82/IB/102/G
31/05/2011 Centralised - Variation (2011)3876 of 27/05/2011
22/07/2012 Centralised - Variation EMEA/H/C/82/II/106 (2012)5281 of 20/07/2012
25/07/2013 Centralised - Variation EMEA/H/C/82/II/111
Updated with Decision(2014)5243 of 18/07/2014
22/07/2014 Centralised - Variation (2014)5243 of 18/07/2014