Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Riprazo HCT
Auth. number : EU/1/11/680
INN : aliskiren / 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.
Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.
Riprazo 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
15/04/2011 Centralised - Authorisation EMEA/H/C/2420 (2011)2750 of 13/04/2011
18/07/2011 Centralised - Notification EMEA/H/C/2420/N/1
Updated with Decision(2011)7941 of 27/10/2011
04/11/2011 Centralised - Variation EMEA/H/C/2420/WS/165, 167, 168, 169 (2011)7941 of 27/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/2420/WS/145, 146 (2011)8685 of 22/11/2011
24/04/2012 Referral EMEA/H/C/2420/A-20/15 (2012)2844 of 20/04/2012
01/06/2012 Centralised - Variation EMEA/H/C/2420/WS/189 (2012)3640 of 25/05/2012
03/07/2012 Centralised - Variation EMEA/H/C/2420/WS/173 (2012)4565 of 28/06/2012
03/09/2012 Centralised - Withdrawal (2012)6159 of 30/08/2012