Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Sprimeo
Auth. number : EU/1/07/407
INN : aliskiren
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09X - Other agents acting on the renin-angiotensin system
Chemical subgroup: C09XA - Renin-inhibitors
Chemical substance: C09XA02 - Aliskiren
(See WHO ATC Index)
Indication: Treatment of essential hypertension
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
24/08/2007 Centralised - Authorisation EMEA/H/C/851 (2007)4033 of 22/08/2007
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/19
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/16
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/15
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/20
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/18
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/17
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/13
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IB/1
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/14
01/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IB/12
11/07/2008 Centralised - Variation EMEA/H/C/851/II/27, 28 (2008)3613 of 09/07/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/II/30
01/09/2008 Centralised - Variation EMEA/H/C/851/II/26 (2008)4738 of 28/08/2008
04/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/II/29
11/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/37
11/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IA/35
08/04/2009 Centralised - Variation EMEA/H/C/851/II/31, 32, 33 (2009)2721 of 03/04/2009
27/04/2009 Centralised - Variation EMEA/H/C/851/II/34 (2009)3193 of 22/04/2009
04/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IB/38
04/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IB/36
25/03/2010 Centralised - Variation EMEA/H/C/851/II/39 (2010)2006 of 23/03/2010
16/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IG/11
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/WS/30
19/10/2010 Centralised - Variation EMEA/H/C/851/WS/27 (2010)7271 of 15/10/2010
27/10/2010 Centralised - Variation EMEA/H/C/851/WS/37 (2010)7538 of 25/10/2010
11/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/WS/56
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IG/32/G
26/01/2011 Centralised - Variation EMEA/H/C/851/WS/69 (2011)408 of 21/01/2011
01/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/851/IB/42/G
09/02/2011 Centralised - Variation EMEA/H/C/851/IB/41/G
Updated with Decision(2011)2083 of 24/03/2011
28/03/2011 Centralised - Variation EMEA/H/C/851/WS/28 (2011)1214 of 21/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/851/WS/73 (2011)2083 of 24/03/2011
23/05/2011 Centralised - Variation EMEA/H/C/851/WS/55, 98 (2011)3610 of 18/05/2011
01/11/2011 Centralised - Variation EMEA/H/C/851/WS/169 (2011)7925 of 27/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/851/WS/145, 146 (2011)8681 of 22/11/2011
24/04/2012 Referral EMEA/H/C/851/A-20/67 (2012)2809 of 20/04/2012
31/05/2012 Centralised - Variation EMEA/H/C/851/WS/189 (2012)3580 of 25/05/2012
06/07/2012 Centralised - Withdrawal (2012)4760 of 04/07/2012