Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rasilez   
Auth. number : EU/1/07/405
Active substance : 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 in adults.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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/780 (2007)4035 of 22/08/2007
12/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/13-20
15/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IB/1,2
23/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/24
04/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IB/23
12/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/II/30
11/07/2008 Centralised - Variation EMEA/H/C/780/II/28, 29 (2008)3610 of 09/07/2008
01/09/2008 Centralised - Variation EMEA/H/C/780/II/26 (2008)4739 of 28/08/2008
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/II/31
08/04/2009 Centralised - Variation EMEA/H/C/780/II/32, 33, 34 (2009)2718 of 03/04/2009
24/04/2009 Centralised - Variation EMEA/H/C/780/II/35 (2009)3192 of 22/04/2009
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/39
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/38
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/37
07/12/2009 Centralised - Variation EMEA/H/C/780/II/36 (2009)9921 of 03/12/2009
31/03/2010 Centralised - Variation EMEA/H/C/780/II/40 (2010)2265 of 30/03/2010
21/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IA/45
28/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IB/44
28/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IB/43
04/06/2010 Centralised - Variation EMEA/H/C/780/II/42 (2010)3648 of 02/06/2010
09/11/2010 Centralised - Variation EMEA/H/C/780/WS/37 (2010)7725 of 03/11/2010
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IG/32/G
25/01/2011 Centralised - Variation EMEA/H/C/780/WS/69 (2011)401 of 21/01/2011
31/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/780/IB/46/G
25/02/2011 Centralised - Variation EMEA/H/C/780/WS/28 (2011)1224 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/780/WS/73 (2011)1914 of 18/03/2011
21/04/2011 Centralised - Variation EMEA/H/C/780/II/41 (2011)2853 of 18/04/2011
25/05/2011 Centralised - Variation EMEA/H/C/780/WS/55, 98 (2011)3712 of 23/05/2011
24/11/2011 Centralised - Variation EMEA/H/C/780/WS/145, 146 (2011)8670 of 22/11/2011
24/04/2012 Referral EMEA/H/C/780/A-20/63 (2012)2806 of 20/04/2012
30/05/2012 Centralised - Variation EMEA/H/C/780/WS/189 (2012)3554 of 25/05/2012
28/08/2012 Centralised - Renewal EMEA/H/C/780/R/62 (2012)6014 of 23/08/2012
26/11/2012 Centralised - Variation EMEA/H/C/780/WS/308/G (2012)8696 of 22/11/2012
29/01/2013 Centralised - Variation EMEA/H/C/780/WS/280/65, EMEA/H/C/780/WS/309/70 (2013)489 of 24/01/2013
20/02/2013 Centralised - Variation EMEA/H/C/780/WS/327 (2013)1008 of 18/02/2013
19/04/2013 Centralised - 2-Monthly update EMEA/H/C/780/WS/287 (2013)2305 of 17/04/2013
21/06/2013 Centralised - Variation EMEA/H/C/780/IB/83
Updated with Decision(2013)5011 of 26/07/2013
01/07/2013 Centralised - 2-Monthly update EMEA/H/C/780/WS/374, 375 (2013)4193 of 27/06/2013
31/07/2013 Centralised - 2-Monthly update EMEA/H/C/780/WS/407/82 (2013)5011 of 26/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/780/WS/412
Updated with Decision(2013)8831 of 03/12/2013
06/12/2013 Centralised - 2-Monthly update EMEA/H/C/780/WS/373 (2013)8831 of 03/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/780/WS/481
Updated with Decision(2014)4502 of 27/06/2014
09/07/2014 PSUSA - Modification EMEA/H/C/780/PSUV/90 (2014)4502 of 27/06/2014
08/09/2014 Referral EMEA/H/C/780/A-31/1370 (2014)6382 of 04/09/2014
22/01/2015 Centralised - Variation EMEA/H/C/780/WS/699/97/G
Updated with Decision(2015)4305 of 19/06/2015
24/06/2015 PSUSA - Modification EMEA/H/C/780/PSUSA/89/201409 (2015)4305 of 19/06/2015