Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Imprida HCT
Auth. number : EU/1/09/570
Active substance : amlodipine besylate / valsartan / hydrochlorothiazide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09D - Angiotensin II antagonists, combinations
Chemical subgroup: C09DX - Angiotensin II antagonists, other combinations
Chemical substance: C09DX01 - Valsartan, amlodipine and hydrochlorothiazide
(See WHO ATC Index)
Indication: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
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
19/10/2009 Centralised - Authorisation EMEA/H/C/1161 (2009)8072 of 15/10/2009
17/11/2009 Corrigendum EMEA/H/C/1161 (2009)8072 corr of 12/11/2009
30/03/2010 Centralised - Variation EMEA/H/C/1161/II/1 (2010)2160 of 26/03/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IA/4
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IB/2/G
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IB/3/G
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/II/5
11/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IA/6/G
11/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IB/7/G
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/IG/32/G
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1161/WS/88/G
30/03/2011 Centralised - Variation EMEA/H/C/1161/WS/97 (2011)2084 of 24/03/2011
03/07/2012 Centralised - Variation EMEA/H/C/1161/WS/177, 253/G (2012)4574 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/1161/WS/250/G (2012)6003 of 23/08/2012
20/10/2012 Centralised - Withdrawal