Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Exforge HCT   
Auth. number : EU/1/09/569
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
Frimley Business Park, Camberley GU16 7SR, 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
20/10/2009 Centralised - Authorisation EMEA/H/C/1068 (2009)8136 of 16/10/2009
30/03/2010 Centralised - Variation EMEA/H/C/1068/II/1 (2010)2159 of 26/03/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IA/4
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IB/3/G
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IB/2/G
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/II/5
11/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IA/6/G
11/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IB/7/G
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/IG/32/G
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1068/WS/88/G
30/03/2011 Centralised - Variation EMEA/H/C/1068/WS/97 (2011)2085 of 24/03/2011
03/07/2012 Centralised - Variation EMEA/H/C/1068/WS/172, 253/G (2012)4575 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/1068/WS/250/G (2012)6011 of 23/08/2012
29/10/2012 Centralised - Variation EMEA/H/C/1068/WS/252/G (2012)7714 of 25/10/2012
02/08/2013 Centralised - 2-Monthly update EMEA/H/C/1068/WS/359 (2013)5132 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/1068/WS/460
Updated with Decision(2014)4587 of 30/06/2014
20/03/2014 Centralised - Variation EMEA/H/C/1068/WS/517
Updated with Decision(2014)4587 of 30/06/2014
09/07/2014 Centralised - Renewal EMEA/H/C/1068/R/37 (2014)4587 of 30/06/2014
08/09/2014 Referral EMEA/H/A-31/1370/C/1068/29 (2014)6367 of 04/09/2014
17/02/2015 Centralised - Variation EMEA/H/C/1068/IG/527
Updated with Decision(2015)3160 of 05/05/2015
27/03/2015 Centralised - Variation EMEA/H/C/1068/IG/539
07/05/2015 Centralised - 2-Monthly update EMEA/H/C/1068/WS/710 (2015)3160 of 05/05/2015