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Community Register of medicinal products
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: | C - Cardiovascular system C09 - Agents acting on the renin-angiotensin system C09D - Angiotensin II antagonists, combinations C09DX - Angiotensin II antagonists, other combinations 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
|
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. |
European Commission procedures
| 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/IA/4 | ||||
| 29/06/2010 | Centralised - Variation | EMEA/H/C/1159/IB/3/G | ||||
| 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 |