Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rapamune   
Auth. number : EU/1/01/171
INN : sirolimus
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: L04AA10 - Sirolimus
(See WHO ATC Index)
Indication: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
15/03/2001 Centralised - Authorisation EMEA/H/C/273 (2001)523 of 13/03/2001
07/08/2001 Centralised - Variation EMEA/H/C/273/I/2 (2002)2079 of 03/08/2001
16/10/2001 Centralised - Variation EMEA/H/C/273/I/3 (2001)2847 of 16/10/2001
16/04/2002 Centralised - Variation EMEA/H/C/273/X/1 (2002)1458 of 12/04/2002
16/04/2002 Centralised - Variation EMEA/H/C/273/II/4 (2002)1459 of 12/04/2002
10/10/2002 Centralised - Variation EMEA/H/C/273/I/10 (2002)3836 of 08/10/2002
14/01/2003 Centralised - Variation EMEA/H/C/273/X/5 (2003)264 of 10/01/2003
30/01/2003 Centralised - Variation EMEA/H/C/273/II/11 (2003)435 of 28/01/2003
03/07/2003 Centralised - Variation EMEA/H/C/273/I/15 (2003)2240 of 30/06/2003
07/08/2003 Centralised - Variation EMEA/H/C/273/I/16 (2003)2940 of 05/08/2003
03/09/2003 Centralised - Variation EMEA/H/C/273/II/14 (2003)3197 of 01/09/2003
09/10/2003 Centralised - Variation EMEA/H/C/273/I/18
10/10/2003 Centralised - Variation EMEA/H/C/273/I/13
07/01/2004 Centralised - Variation EMEA/H/C/273/II/17
30/01/2004 Centralised - Variation EMEA/H/C/273/IB/20
03/02/2004 Centralised - Variation EMEA/H/C/273/II/19 (2004)287 of 29/01/2004
07/04/2004 Centralised - Variation EMEA/H/C/273/IA/22
07/04/2004 Centralised - Variation EMEA/H/C/273/IA/23
06/09/2004 Centralised - Variation EMEA/H/C/273/II/24 (2004)3424 of 02/09/2004
21/09/2004 Centralised - Variation EMEA/H/C/273/IA/26
21/09/2004 Centralised - Variation EMEA/H/C/273/IA/27
11/11/2004 Centralised - Variation EMEA/H/C/273/IB/28
24/01/2005 Centralised - Variation EMEA/H/C/273/X/21 (2005)159 of 20/01/2005
30/03/2005 Centralised - Variation EMEA/H/C/273/N/25
Updated with Decision(2005)1418 of 28/04/2005
13/04/2005 Centralised - Variation EMEA/H/C/273/IA/31
03/05/2005 Centralised - Variation EMEA/H/C/273/II/29 (2005)1418 of 28/04/2005
23/05/2005 Centralised - Variation EMEA/H/C/273/IA/32
30/06/2005 Centralised - Variation EMEA/H/C/273/II/30
31/08/2005 Centralised - Variation EMEA/H/C/273/IB/34
09/11/2005 Centralised - Variation EMEA/H/C/273/II/33 (2005)4389 of 07/11/2005
11/01/2006 Centralised - Variation EMEA/H/C/273/II/35 (2006)37 of 09/01/2006
02/03/2006 Centralised - Variation EMEA/H/C/273/II/36 (2006)701 of 28/02/2006
10/03/2006 Centralised - Variation EMEA/H/C/273/IA/39
10/04/2006 Centralised - Renewal EMEA/H/C/273/R/37 (2006)1576 of 06/04/2006
27/04/2006 Centralised - Variation EMEA/H/C/273/IA/42
Updated with Decision(2006)2233 of 31/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/273/II/38 (2006)2233 of 31/05/2006
11/07/2006 Centralised - Variation EMEA/H/C/273/IB/45
Updated with Decision(2006)4126 of 07/09/2006
02/08/2006 Centralised - Variation EMEA/H/C/273/II/40, 41 (2006)3536 of 28/07/2006
08/08/2006 Centralised - Variation EMEA/H/C/273/IA/46
12/09/2006 Centralised - Variation EMEA/H/C/273/II/43 (2006)4126 of 07/09/2006
04/04/2007 Centralised - Variation EMEA/H/C/273/II/47, 48 (2007)1537 of 29/03/2007
11/04/2007 Centralised - Variation EMEA/H/C/273/IA/50
28/06/2007 Centralised - Variation EMEA/H/C/273/IA/54
Updated with Decision(2007)4072 of 27/08/2007
06/07/2007 Centralised - Variation EMEA/H/C/273/IA/55
24/07/2007 Centralised - Variation EMEA/H/C/273/II/52
30/07/2007 Centralised - Variation EMEA/H/C/273/II/51 (2007)3702 of 25/07/2007
01/08/2007 Centralised - Variation EMEA/H/C/273/IA/57
29/08/2007 Centralised - Variation EMEA/H/C/273/II/53 (2007)4072 of 27/08/2007
21/09/2007 Centralised - Variation EMEA/H/C/273/IB/59
22/10/2007 Centralised - Variation EMEA/H/C/273/IA/61
Updated with Decision(2007)5696 of 20/11/2007
22/11/2007 Centralised - Variation EMEA/H/C/273/II/58 (2007)5696 of 20/11/2007
04/12/2007 Centralised - Variation EMEA/H/C/273/IA/63
19/12/2007 Centralised - Variation EMEA/H/C/273/II/60
24/01/2008 Centralised - Variation EMEA/H/C/273/IA/65
28/01/2008 Centralised - Variation EMEA/H/C/273/IB/64
03/04/2008 Centralised - Variation EMEA/H/C/273/IA/66
Updated with Decision(2008)6602 of 30/10/2008
24/04/2008 Centralised - Variation EMEA/H/C/273/II/62 (2008)1655 of 21/04/2008
18/07/2008 Centralised - Variation EMEA/H/C/273/IA/69
Updated with Decision(2008)6602 of 30/10/2008
01/09/2008 Centralised - Variation EMEA/H/C/273/IA/72
04/11/2008 Centralised - Variation EMEA/H/C/273/II/67, 68, 70 (2008)6602 of 30/10/2008
08/04/2009 Centralised - Variation EMEA/H/C/273/IA/76
01/05/2009 Centralised - Variation EMEA/H/C/273/IB/77
05/05/2009 Centralised - Variation EMEA/H/C/273/II/74 (2009)3450 of 29/04/2009
01/06/2009 Centralised - Variation EMEA/H/C/273/IA/80
04/06/2009 Centralised - Variation EMEA/H/C/273/II/65
16/06/2009 Centralised - Variation EMEA/H/C/273/IA/81
16/06/2009 Centralised - Variation EMEA/H/C/273/IA/82
18/06/2009 Centralised - Variation EMEA/H/C/273/IA/85
18/06/2009 Centralised - Variation EMEA/H/C/273/IA/84
18/06/2009 Centralised - Variation EMEA/H/C/273/IA/86
22/06/2009 Centralised - Variation EMEA/H/C/273/IB/87
01/07/2009 Centralised - Variation EMEA/H/C/273/II/78
29/07/2009 Centralised - Variation EMEA/H/C/273/II/79
30/07/2009 Centralised - Variation EMEA/H/C/273/IA/89
30/07/2009 Centralised - Variation EMEA/H/C/273/IA/88
17/08/2009 Centralised - Variation EMEA/H/C/273/IB/91
21/08/2009 Centralised - Variation EMEA/H/C/273/IA/92
23/12/2009 Centralised - Variation EMEA/H/C/273/II/90 (2009)10691 of 21/12/2009
04/01/2010 Centralised - Variation EMEA/H/C/273/IA/96
Updated with Decision(2010)1769 of 15/03/2010
07/01/2010 Centralised - Variation EMEA/H/C/273/IB/95
01/02/2010 Centralised - Variation EMEA/H/C/273/II/94 (2010)663 of 28/01/2010
10/03/2010 Centralised - Variation EMEA/H/C/273/IA/97
17/03/2010 Centralised - Variation (2010)1769 of 15/03/2010
22/04/2010 Centralised - Variation EMEA/H/C/273/IA/105, 107/NC
22/04/2010 Centralised - Variation EMEA/H/C/273/IA/106/G
22/04/2010 Centralised - Variation EMEA/H/C/273/IA/108
22/04/2010 Centralised - Variation EMEA/H/C/273/IA/99_100
25/05/2010 Centralised - Variation EMEA/H/C/273/IB/104
18/06/2010 Centralised - Variation EMEA/H/C/273/IB/103
18/06/2010 Centralised - Variation EMEA/H/C/273/IB/102
18/06/2010 Centralised - Variation EMEA/H/C/273/IB/101/G
28/06/2010 Centralised - Variation EMEA/H/C/273/IA/109/G
28/06/2010 Centralised - Variation
05/07/2010 Centralised - Variation EMEA/H/C/273/II/98 (2010)4665 of 01/07/2010
12/07/2010 Centralised - Variation EMEA/H/C/273/X/93 (2010)4815 of 06/07/2010
23/07/2010 Centralised - Variation EMEA/H/C/273/IA/110
03/08/2010 Centralised - Variation EMEA/H/C/273/IB/114/G
09/08/2010 Centralised - Variation EMEA/H/C/273/IB/112
09/08/2010 Centralised - Variation EMEA/H/C/273/IB/111
10/08/2010 Centralised - Variation EMEA/H/C/273/IB/113
Updated with Decision(2011)79 of 06/01/2011
11/08/2010 Centralised - Variation EMEA/H/C/273/IA/116/G
11/08/2010 Centralised - Variation EMEA/H/C/273/IA/117
11/08/2010 Centralised - Variation EMEA/H/C/273/IA/118
20/08/2010 Centralised - Variation EMEA/H/C/273/IB/115
Updated with Decision(2011)79 of 06/01/2011
16/09/2010 Centralised - Variation EMEA/H/C/273/IB/119
15/11/2010 Centralised - Variation EMEA/H/C/273/IB/122
07/01/2011 Centralised - Variation EMEA/H/C/273/IA/123
11/01/2011 Centralised - Renewal EMEA/H/C/273/R/120 (2011)79 of 06/01/2011
26/01/2011 Centralised - Variation EMEA/H/C/273/II/121 (2011)407 of 21/01/2011
10/02/2011 Centralised - Variation EMEA/H/C/273/IA/124
10/02/2011 Centralised - Variation EMEA/H/C/273/IA/124
16/02/2011 Centralised - Variation EMEA/H/C/273/IB/126
16/05/2011 Centralised - Variation EMEA/H/C/273/IA/128
Updated with Decision(2011)5598 of 27/07/2011
26/05/2011 Centralised - Variation EMEA/H/C/273/WS/117 (2011)3719 of 23/05/2011
01/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/273/T/129 (2011)5598 of 27/07/2011
24/11/2011 Centralised - Variation EMEA/H/C/273/IA/132
Updated with Decision(2012)823 of 06/02/2012
09/02/2012 Centralised - Variation (2012)823 of 06/02/2012
04/04/2012 Centralised - Variation EMEA/H/C/273/IB/135
Updated with Decision(2012)7209 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7209 of 10/10/2012
09/11/2012 Centralised - Variation EMEA/H/C/273/IAin/141
Updated with Decision(2013)7951 of 11/11/2013
15/11/2012 Centralised - Variation EMEA/H/C/273/II/139
Updated with Decision(2013)7951 of 11/11/2013
13/12/2012 Centralised - Variation EMEA/H/C/273/II/140
Updated with Decision(2013)7951 of 11/11/2013
26/03/2013 Centralised - Variation EMEA/H/C/273/IAin/146/G
Updated with Decision(2013)7951 of 11/11/2013
29/07/2013 Centralised - Variation EMEA/H/C/273/N/147
Updated with Decision(2013)7951 of 11/11/2013
21/08/2013 Centralised - Variation EMEA/H/C/273/IB/148
Updated with Decision(2013)7951 of 11/11/2013
13/11/2013 Centralised - Variation (2013)7951 of 11/11/2013