Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Riprazo
Auth. number : EU/1/07/409
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 continues to be 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/853 (2007)4032 of 22/08/2007
11/07/2008 Centralised - Variation EMEA/H/C/853/II/27, 28 (2008)3611 of 09/07/2008
29/07/2008 Centralised - Variation EMEA/H/C/853/II/30
01/09/2008 Centralised - Variation EMEA/H/C/853/II/26 (2008)4740 of 28/08/2008
04/11/2008 Centralised - Variation EMEA/H/C/853/II/29
11/02/2009 Centralised - Variation EMEA/H/C/853/IA/35
11/02/2009 Centralised - Variation EMEA/H/C/853/IA/37
08/04/2009 Centralised - Variation EMEA/H/C/853/II/31, 32, 33 (2009)2724 of 03/04/2009
24/04/2009 Centralised - Variation EMEA/H/C/853/II/34 (2009)3190 of 22/04/2009
04/05/2009 Centralised - Variation EMEA/H/C/853/IB/36
04/05/2009 Centralised - Variation EMEA/H/C/853/IB/38
25/03/2010 Centralised - Variation EMEA/H/C/853/II/39 (2010)2013 of 23/03/2010
14/07/2010 Centralised - Variation EMEA/H/C/853/IG/11
28/09/2010 Centralised - Variation EMEA/H/C/853/WS/30
14/10/2010 Centralised - Variation EMEA/H/C/853/N/40
Updated with Decision(2011)691 of 01/02/2011
19/10/2010 Centralised - Variation EMEA/H/C/853/WS/27 (2010)7272 of 15/10/2010
26/10/2010 Centralised - Variation EMEA/H/C/853/WS/56
09/11/2010 Centralised - Variation EMEA/H/C/853/WS/37 (2010)7724 of 03/11/2010
21/01/2011 Centralised - Variation EMEA/H/C/853/IG/32/G
31/01/2011 Centralised - Variation EMEA/H/C/853/IB/43/G
03/02/2011 Centralised - Variation EMEA/H/C/853/WS/69 (2011)691 of 01/02/2011
09/02/2011 Centralised - Variation EMEA/H/C/853/IB/42/G
Updated with Decision(2011)1915 of 18/03/2011
28/02/2011 Centralised - Variation EMEA/H/C/853/WS/28 (2011)1223 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/853/WS/73 (2011)1915 of 18/03/2011
26/05/2011 Centralised - Variation EMEA/H/C/853/WS/55, 98 (2011)3725 of 23/05/2011
01/11/2011 Centralised - Variation EMEA/H/C/853/WS/169 (2011)7929 of 27/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/853/WS/145, 146 (2011)8671 of 22/11/2011
24/04/2012 Referral EMEA/H/C/853/A-20/69 (2012)2805 of 20/04/2012
30/05/2012 Centralised - Variation EMEA/H/C/853/WS/189 (2012)3555 of 25/05/2012
28/08/2012 Centralised - Renewal EMEA/H/C/853/R/68 (2012)6015 of 23/08/2012
26/11/2012 Centralised - Variation EMEA/H/C/853/WS/308/G (2012)8697 of 22/11/2012
29/01/2013 Centralised - Withdrawal (2013)488 of 24/01/2013