Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Torisel   
Auth. number : EU/1/07/424
Active substance : Temsirolimus
Orphan market exclusivity for "Treatment of renal cell carcinoma" (based on designation EU/3/06/365) started on 21/11/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/11/2017
Orphan market exclusivity for "Treatment of mantle cell lymphoma" (based on designation EU/3/06/420) started on 25/08/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 25/08/2019
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE09 - Temsirolimus
(See WHO ATC Index)
Indication: Renal cell carcinoma: first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors
Mantle cell lymphoma: treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [MCL]
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
21/11/2007 Centralised - Authorisation EMEA/H/C/799 (2007)5681 of 19/11/2007
04/04/2008 Centralised - Notification EMEA/H/C/799/N/2
Updated with Decision(2009)4222 of 26/05/2009
19/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/4
17/12/2008 Centralised - Variation EMEA/H/C/799/IA/5
Updated with Decision(2009)4222 of 26/05/2009
09/01/2009 Centralised - Variation EMEA/H/C/799/II/3 (2009)51 of 07/01/2009
24/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/9
24/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/8
28/05/2009 Centralised - Variation EMEA/H/C/799/II/6 (2009)4222 of 26/05/2009
11/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/7
25/08/2009 Centralised - Variation EMEA/H/C/799/II/1 (2009)6634 of 21/08/2009
10/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/14
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/13
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/11
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/12
16/10/2009 Corrigendum EMEA/H/C/799/II/1 (2009)8006 cor of 14/10/2009
04/01/2010 Centralised - Variation EMEA/H/C/799/II/10 (2009)10776 of 23/12/2009
27/01/2010 Centralised - Variation EMEA/H/C/799/II/15 (2010)523 of 25/01/2010
23/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/23
05/05/2010 Centralised - Variation EMEA/H/C/799/IA/17
Updated with Decision(2010)4706 of 02/07/2010
05/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/24
05/05/2010 Centralised - Variation EMEA/H/C/799/IA/18
Updated with Decision(2010)4706 of 02/07/2010
05/05/2010 Centralised - Variation EMEA/H/C/799/IA/19
Updated with Decision(2010)4706 of 02/07/2010
05/05/2010 Centralised - Variation EMEA/H/C/799/IA/20
Updated with Decision(2010)4706 of 02/07/2010
05/05/2010 Centralised - Variation EMEA/H/C/799/IA/21
Updated with Decision(2010)4706 of 02/07/2010
02/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/22
07/07/2010 Centralised - Variation EMEA/H/C/799/II/16 (2010)4706 of 02/07/2010
12/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/26
15/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/25
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/30
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IB/29
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/799/IA/28
09/11/2010 Centralised - Variation EMEA/H/C/799/II/27 (2010)7826 of 05/11/2010
15/12/2010 Centralised - Variation EMEA/H/C/799/IB/33
Updated with Decision(2011)469 of 24/01/2011
27/01/2011 Centralised - Variation EMEA/H/C/799/II/31 (2011)469 of 24/01/2011
03/03/2011 Centralised - Variation EMEA/H/C/799/IB/34
Updated with Decision(2011)4624 of 23/06/2011
27/06/2011 Centralised - Variation EMEA/H/C/799/II/32 (2011)4624 of 23/06/2011
06/09/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/799/T/39 (2011)6343 of 02/09/2011
09/12/2011 Referral EMEA/H/C/799/A-20/45 (2011)9289 of 07/12/2011
30/05/2012 Referral EMEA/H/C/799/A-20/45 (2012)3564 of 25/05/2012
24/09/2012 Centralised - Renewal EMEA/H/C/799/R/47 (2012)6704 of 20/09/2012
26/09/2012 Referral EMEA/H/C/799/A-20/51 (2012)6846 of 24/09/2012
15/11/2012 Centralised - Variation EMEA/H/C/799/II/52
Updated with Decision(2013)8345 of 20/11/2013
18/02/2013 Centralised - Variation EMEA/H/C/799/IAin/54
Updated with Decision(2013)8345 of 20/11/2013
27/06/2013 Centralised - Variation EMEA/H/C/799/II/55
Updated with Decision(2013)8345 of 20/11/2013
24/10/2013 Centralised - Variation EMEA/H/C/799/II/57
Updated with Decision(2013)8345 of 20/11/2013
22/11/2013 Centralised - Yearly update (2013)8345 of 20/11/2013
25/10/2014 Centralised - Variation EMEA/H/C/799/II/58
Updated with Decision(2015)7206 of 15/10/2015
12/11/2014 Centralised - Variation EMEA/H/C/799/IB/59/G
Updated with Decision(2015)7206 of 15/10/2015
24/06/2015 Centralised - Notification EMEA/H/C/799/N/60
Updated with Decision(2015)7206 of 15/10/2015
19/10/2015 Centralised - Yearly update (2015)7206 of 15/10/2015
17/12/2015 Centralised - Variation EMEA/H/C/799/II/62
Updated with Decision(2016)8649 of 12/12/2016
18/01/2016 PSUSA - Modification EMEA/H/C/PSUSA/2887/201503 (2016)228 of 14/01/2016
14/12/2016 Centralised - Yearly update (2016)8649 of 12/12/2016
15/12/2016 Centralised - Variation EMEA/H/C/000799/II/0064
Updated with Decision(2017)5084 of 13/07/2017
23/02/2017 Centralised - Variation EMEA/H/C/000799/II/63
Updated with Decision(2017)5084 of 13/07/2017
17/07/2017 Centralised - Renewal EMEA/H/C/000799/R/0065 (2017)5084 of 13/07/2017