Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rasilez HCT   
Auth. number : EU/1/08/491
INN : aliskiren hemifumarate / hydrochlorothiazide
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: C09XA52 - Aliskiren and hydrochlorothiazide
(See WHO ATC Index)
Indication: Treatment of essential hypertension in adults.Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
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
20/01/2009 Centralised - Authorisation EMEA/H/C/964 (2009)235 of 16/01/2009
24/04/2009 Centralised - Variation EMEA/H/C/964/N/1
Updated with Decision(2010)2182 of 26/03/2010
08/12/2009 Centralised - Variation EMEA/H/C/964/II/2
24/03/2010 Centralised - Variation EMEA/H/C/964/II/3
30/03/2010 Centralised - Variation EMEA/H/C/964/II/4 (2010)2182 of 26/03/2010
08/06/2010 Centralised - Variation EMEA/H/C/964/II/6 (2010)3706 of 04/06/2010
05/11/2010 Centralised - Variation EMEA/H/C/964/WS/37 (2010)7716 of 03/11/2010
13/01/2011 Centralised - Variation EMEA/H/C/964/IG/32
01/02/2011 Centralised - Variation EMEA/H/C/964/WS/69 (2011)573 of 27/01/2011
04/02/2011 Centralised - Variation EMEA/H/C/964/IB/7/G
25/02/2011 Centralised - Variation EMEA/H/C/964/WS/28 (2011)1231 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/964/WS/73 (2011)1931 of 18/03/2011
12/05/2011 Centralised - Variation EMEA/H/C/964/II/5/G (2011)3237 of 06/05/2011
01/07/2011 Centralised - Variation EMEA/H/C/964/WS/55, 98 (2011)4804 of 29/06/2011
24/11/2011 Centralised - Variation EMEA/H/C/964/WS/145, 146 (2011)8682 of 22/11/2011
27/04/2012 Referral EMEA/H/C/964/A-20/26 (2012)2908 of 24/04/2012
31/05/2012 Centralised - Variation EMEA/H/C/964/WS/189 (2012)3583 of 25/05/2012
03/07/2012 Centralised - Variation EMEA/H/C/964/WS/173 (2012)4605 of 28/06/2012
26/11/2012 Centralised - Variation EMEA/H/C/964/WS/308/G (2012)8699 of 22/11/2012
30/01/2013 Centralised - Variation EMEA/H/C/964/WS/280, 309 (2013)531 of 28/01/2013
20/02/2013 Centralised - Variation EMEA/H/C/964/WS/316, 327 (2013)1017 of 18/02/2013
19/04/2013 Centralised - Variation EMEA/H/C/964/WS/287 (2013)2307 of 17/04/2013
03/07/2013 Centralised - Variation EMEA/H/C/964/WS/374, 0375 (2013)4229 of 01/07/2013
25/07/2013 Centralised - Variation EMEA/H/C/964/II/50
Updated with Decision(2013)8072 of 13/11/2013
31/07/2013 Centralised - Variation EMEA/H/C/964/WS/407 (2013)5010 of 26/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/964/WS/412/52
Updated with Decision(2013)8072 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/964/R/49 (2013)8072 of 13/11/2013
06/12/2013 Centralised - Variation EMEA/H/C/964/WS/373 (2013)8835 of 03/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/964/WS/481
Updated with Decision(2014)4506 of 27/06/2014
09/07/2014 Centralised - Modification EMEA/H/C/964/PSUV/60 (2014)4506 of 27/06/2014