- Current languageen
Pharmaceuticals - Community Register
Community list of not active medicinal products for human use
|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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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.
|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 - Variation||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|