Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Rasitrio
Auth. number : EU/1/11/730
Active substance : aliskiren / amlodipine / 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: C09XA54 - naproxen and esomeprazole
(See WHO ATC Index)
Indication: Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine 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
24/11/2011 Centralised - Authorisation EMEA/H/C/2017 (2011)8695 of 22/11/2011
22/04/2012 Referral EMEA/H/C/2017/A-20/1 (2012)2864 of 20/04/2012
31/05/2012 Centralised - Variation EMEA/H/C/2017/II/3/G (2012)3597 of 25/05/2012
24/08/2012 Centralised - Variation EMEA/H/C/2017/IB/15
Updated with Decision(2012)8705 of 22/11/2012
12/09/2012 Centralised - Variation EMEA/H/C/2017/WS/279 (2012)6394 of 10/09/2012
26/11/2012 Centralised - Variation EMEA/H/C/2017/II/16, 17, EMEA/H/C/2017WS/277 (2012)8705 of 22/11/2012
23/01/2013 Centralised - Variation EMEA/H/C/2017/WS/280, 309 (2013)362 of 21/01/2013
20/02/2013 Centralised - 2-Monthly update EMEA/H/C/2017/WS/316/23, EMEA/H/C/2017/WS/327/24 (2013)1011 of 18/02/2013
12/04/2013 Centralised - 2-Monthly update EMEA/H/C/2017/WS/287 (2013)2130 of 10/04/2013
08/07/2013 Centralised - 2-Monthly update EMEA/H/C/2017/WS/374, 375 (2013)4361 of 04/07/2013
30/07/2013 Centralised - 2-Monthly update EMEA/H/C/2017/WS/407 (2013)5003 of 26/07/2013
05/09/2013 Centralised - Withdrawal (2013)5750 of 03/09/2013