Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Copalia HCT   
Auth. number : EU/1/09/575
INN : 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
06/11/2009 Centralised - Authorisation EMEA/H/C/1159 (2009)8664 of 04/11/2009
25/03/2010 Centralised - Variation EMEA/H/C/1159/II/1 (2010)2017 of 23/03/2010
29/06/2010 Centralised - Variation EMEA/H/C/1159/IB/2/G
29/06/2010 Centralised - Variation EMEA/H/C/1159/IB/3/G
29/06/2010 Centralised - Variation EMEA/H/C/1159/IA/4
21/09/2010 Centralised - Variation EMEA/H/C/1159/IA/6/G
30/09/2010 Centralised - Variation EMEA/H/C/1159/II/5
04/11/2010 Centralised - Variation EMEA/H/C/1159/IB/7/G
21/01/2011 Centralised - Variation EMEA/H/C/1159/IG/32/G
24/02/2011 Centralised - Variation EMEA/H/C/1159/WS/88/G
22/03/2011 Centralised - Variation EMEA/H/C/1159/WS/97 (2011)1883 of 17/03/2011
03/07/2012 Centralised - Variation EMEA/H/C/1159/WS/172, 253/G (2012)4597 of 28/06/2012
03/09/2012 Centralised - Variation EMEA/H/C/1159/WS/250/G (2012)6125 of 30/08/2012
06/11/2012 Centralised - Variation EMEA/H/C/1159/WS/252/G (2012)7993 of 31/10/2012
05/08/2013 Centralised - Variation EMEA/H/C/1159/WS/359 (2013)5147 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/1159/WS/460
Updated with Decision(2014)4851 of 04/07/2014
20/03/2014 Centralised - Variation EMEA/H/C/1159/WS/517
Updated with Decision(2014)4851 of 04/07/2014
11/07/2014 Centralised - Renewal EMEA/H/C/1159/R/38 (2014)4851 of 04/07/2014