Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Simulect   
Auth. number : EU/1/98/084
INN : basiliximab
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: L04AA02 - Muromonab-CD3
(See WHO ATC Index)
Indication: Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
14/10/1998 Centralised - Authorisation EMEA/H/C/207 (1998)3098 of 09/10/1998
05/08/1999 Centralised - Variation EMEA/H/C/207/I/1 (1999)2548 of 29/07/1999
05/08/1999 Centralised - Variation EMEA/H/C/207/N/6 (1999)2548 of 29/07/1999
10/02/2000 Centralised - Variation EMEA/H/C/207/I/7 (2000)180 of 08/02/2000
20/07/2000 Centralised - Variation EMEA/H/C/207/II/13 (2000)1797 of 11/07/2000
04/12/2000 Centralised - Variation EMEA/H/C/207/II/14, 16 (2000)3422 of 01/12/2000
05/02/2001 Centralised - Variation EMEA/H/C/207/I/17
05/02/2001 Centralised - Variation EMEA/H/C/207/I/19
29/03/2001 Centralised - Variation EMEA/H/C/207/I/18 (2001)787 of 26/03/2001
14/02/2002 Centralised - Variation EMEA/H/C/207/I/23, 25
27/02/2002 Centralised - Variation EMEA/H/C/207/I/20, 21
04/04/2002 Centralised - Variation EMEA/H/C/207/N/22 (2002)1393 of 02/04/2002
18/09/2002 Centralised - Variation EMEA/H/C/207/I/27
25/09/2002 Centralised - Variation EMEA/H/C/207/II/29
25/10/2002 Centralised - Variation EMEA/H/C/207/II/28
11/03/2003 Centralised - Variation EMEA/H/C/207/X/26 (2003)811 of 07/03/2003
28/05/2003 Centralised - Variation EMEA/H/C/207/II/31 (2003)1800 of 23/05/2003
06/06/2003 Centralised - Variation EMEA/H/C/207/I/32 (2003)1842 of 04/06/2003
22/10/2003 Centralised - Renewal EMEA/H/C/207/R/33 (2003)3968 of 20/10/2003
03/05/2004 Centralised - Variation EMEA/H/C/207/N/34
Updated with Decision(2005)2743 of 08/07/2005
11/11/2004 Centralised - Variation EMEA/H/C/207/IB/36
11/11/2004 Centralised - Variation EMEA/H/C/207/IB/38
16/12/2004 Centralised - Variation EMEA/H/C/207/IB/39
21/12/2004 Centralised - Variation EMEA/H/C/207/II/35
12/07/2005 Centralised - Variation EMEA/H/C/207/II/40 (2005)2743 of 08/07/2005
02/02/2006 Centralised - Variation EMEA/H/C/207/II/41 (2006)308 of 31/01/2006
10/05/2007 Centralised - Variation EMEA/H/C/207/N/43
Updated with Decision(2007)3404 of 09/07/2007
28/06/2007 Centralised - Variation EMEA/H/C/207/II/42
11/07/2007 Centralised - Variation EMEA/H/C/207/II/44 (2007)3404 of 09/07/2007
01/10/2007 Centralised - Variation EMEA/H/C/207/II/47
01/10/2007 Centralised - Variation EMEA/H/C/207/II/46
04/03/2008 Centralised - Variation EMEA/H/C/207/IA/48
Updated with Decision(2008)5968 of 08/10/2008
10/10/2008 Centralised - Renewal EMEA/H/C/207/R/49 (2008)5968 of 08/10/2008
27/10/2008 Centralised - Variation EMEA/H/C/207/II/50
25/03/2009 Centralised - Variation EMEA/H/C/207/II/51
25/03/2009 Centralised - Variation EMEA/H/C/207/II/52
08/12/2009 Centralised - Variation EMEA/H/C/207/II/53
08/12/2009 Centralised - Variation EMEA/H/C/207/II/54
08/02/2011 Centralised - Variation EMEA/H/C/207/IB/55
10/02/2011 Centralised - Variation EMEA/H/C/207/IB/58
24/02/2011 Centralised - Variation EMEA/H/C/207/II/56/G
23/03/2011 Centralised - Variation EMEA/H/C/207/II/57 (2011)1932 of 18/03/2011
31/03/2011 Centralised - Variation EMEA/H/C/207/II/59
19/05/2011 Centralised - Variation EMEA/H/C/207/IG/65
15/07/2011 Centralised - Variation EMEA/H/C/207/IA/61
Updated with Decision(2011)9756 of 14/12/2011
19/12/2011 Centralised - Variation EMEA/H/C/207/II/63, 64, 65 (2011)9756 of 14/12/2011
01/02/2012 Centralised - Variation EMEA/H/C/207/II/66/G (2012)595 of 30/01/2012
10/07/2012 Centralised - Variation EMEA/H/C/207/II/68 (2012)4850 of 06/07/2012
09/01/2014 Centralised - Variation EMEA/H/C/207/N/74