Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Copalia   
Auth. number : EU/1/06/372
INN : amlodipine / valsartan
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: C09DB - Angiotensin II antagonists and calcium channel blockers
Chemical substance: C09DB01 - Valsartan and amlodipine
(See WHO ATC Index)
Indication: Treatment of essential hypertension.Copalia is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
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
18/01/2007 Centralised - Authorisation EMEA/H/C/774 (2007)175 of 16/01/2007
03/04/2007 Centralised - Variation EMEA/H/C/774/IA/2
03/04/2007 Centralised - Variation EMEA/H/C/774/IA/3
03/04/2007 Centralised - Variation EMEA/H/C/774/IA/1
27/04/2007 Centralised - Variation EMEA/H/C/774/IA/4
18/07/2007 Centralised - Variation EMEA/H/C/774/IB/6
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/14
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/15
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/13
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/12
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/11
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/10
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/9
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/7
Updated with Decision(2008)2514 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/774/IA/8
Updated with Decision(2008)2514 of 02/06/2008
24/09/2007 Centralised - Variation EMEA/H/C/774/IA/16
15/01/2008 Centralised - Variation EMEA/H/C/774/IB/17
Updated with Decision(2008)2514 of 02/06/2008
06/05/2008 Centralised - Variation EMEA/H/C/774/IA/22
Updated with Decision(2009)1122 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/774/IA/21
Updated with Decision(2009)1122 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/774/IA/23
Updated with Decision(2009)1122 of 13/02/2009
28/05/2008 Centralised - Variation EMEA/H/C/774/N/18
Updated with Decision(2009)1122 of 13/02/2009
30/05/2008 Centralised - Variation EMEA/H/C/774/IA/24
04/06/2008 Centralised - Variation (2008)2514 of 02/06/2008
12/06/2008 Centralised - Variation EMEA/H/C/774/II/20 (2008)2743 of 10/06/2008
30/06/2008 Centralised - Variation EMEA/H/C/774/IA/26
03/07/2008 Centralised - Variation EMEA/H/C/774/IB/25
07/07/2008 Centralised - Variation EMEA/H/C/774/IA/27
10/07/2008 Centralised - Variation EMEA/H/C/774/IA/28
23/10/2008 Centralised - Variation EMEA/H/C/774/IA/33
23/10/2008 Centralised - Variation EMEA/H/C/774/IA/34
31/10/2008 Centralised - Variation EMEA/H/C/774/IB/32
17/02/2009 Centralised - Variation EMEA/H/C/774/II/31 (2009)1122 of 13/02/2009
24/02/2009 Centralised - Variation EMEA/H/C/774/IA/36
17/03/2009 Centralised - Variation EMEA/H/C/774/IB/37
01/04/2009 Centralised - Variation EMEA/H/C/774/II/35 (2009)2466 of 27/03/2009
30/07/2009 Centralised - Variation EMEA/H/C/774/IA/39
30/07/2009 Centralised - Variation EMEA/H/C/774/IA/40
17/08/2009 Centralised - Variation EMEA/H/C/774/IA/41
05/10/2009 Centralised - Variation EMEA/H/C/774/II/38
26/11/2009 Centralised - Variation EMEA/H/C/774/II/42
30/11/2009 Centralised - Variation EMEA/H/C/774/IA/45
30/11/2009 Centralised - Variation EMEA/H/C/774/IB/43
Updated with Decision(2010)1773 of 15/03/2010
08/12/2009 Centralised - Variation EMEA/H/C/774/IA/44
17/03/2010 Centralised - Variation (2010)1773 of 15/03/2010
23/03/2010 Centralised - Variation EMEA/H/C/774/II/46 (2010)1947 of 19/03/2010
14/06/2010 Centralised - Variation EMEA/H/C/774/IA/47/G
Updated with Decision(2011)187 of 13/01/2011
30/06/2010 Centralised - Variation EMEA/H/C/774/IB/48/G
15/11/2010 Centralised - Variation EMEA/H/C/775/IG/28
13/01/2011 Centralised - Variation EMEA/H/C/774/IG/32/G
Updated with Decision(2011)2628 of 08/04/2011
17/01/2011 Centralised - Variation (2011)187 of 13/01/2011
24/02/2011 Centralised - Variation EMEA/H/C/774/WS/88/G
12/04/2011 Centralised - Variation (2011)2628 of 08/04/2011
01/08/2011 Centralised - Variation EMEA/H/C/774/WS/100/G (2011)5589 of 27/07/2011
22/11/2011 Centralised - Renewal EMEA/H/C/774/R/49 (2011)8642 of 21/11/2011
10/05/2012 Centralised - Variation EMEA/H/C/774/N/61
Updated with Decision(2012)4573 of 28/06/2012
03/07/2012 Centralised - Variation EMEA/H/C/774/WS/251/G (2012)4573 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/774/WS/248/G (2012)6002 of 23/08/2012
29/10/2012 Centralised - Variation EMEA/H/C/774/WS/249/G (2012)7711 of 25/10/2012
02/08/2013 Centralised - Variation EMEA/H/C/774/WS/360 (2013)5130 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/774/WS/461
20/03/2014 Centralised - Variation EMEA/H/C/774/WS/516