Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Exforge   
Auth. number : EU/1/06/370
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. Exforge is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
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
19/01/2007 Centralised - Authorisation EMEA/H/C/716 (2007)184 of 17/01/2007
03/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/2
03/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/1
03/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/3
27/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/6
18/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IB/6
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/14
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/15
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/13
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/12
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/11
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/10
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/9
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/7
Updated with Decision(2008)2536 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/716/IA/8
Updated with Decision(2008)2536 of 03/06/2008
24/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/16
15/01/2008 Centralised - Variation EMEA/H/C/716/IB/17
Updated with Decision(2008)2536 of 03/06/2008
06/05/2008 Centralised - Variation EMEA/H/C/716/IA/22
Updated with Decision(2009)1121 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/716/IA/21
Updated with Decision(2009)1121 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/716/IA/20
Updated with Decision(2009)1121 of 13/02/2009
05/06/2008 Centralised - Variation (2008)2536 of 03/06/2008
12/06/2008 Centralised - Variation EMEA/H/C/716/II/19 (2008)2737 of 10/06/2008
23/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/32
23/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/33
31/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IB/31
17/02/2009 Centralised - Variation EMEA/H/C/716/II/30 (2009)1121 of 13/02/2009
24/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/35
01/04/2009 Centralised - Variation EMEA/H/C/716/II/34 (2009)2464 of 27/03/2009
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/39
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/38
17/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/40
07/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/719/II/37
30/11/2009 Centralised - Variation EMEA/H/C/716/IB/42
Updated with Decision(2010)921 of 09/02/2010
30/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IB/44
02/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/II/41
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IA/43
11/02/2010 Centralised - Variation (2010)921 of 09/02/2010
17/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IB/36
25/03/2010 Centralised - Variation EMEA/H/C/716/II/45 (2010)2035 of 23/03/2010
08/06/2010 Centralised - Variation EMEA/H/C/716/IA/46/G
Updated with Decision(2011)695 of 01/02/2011
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IB/47/G
15/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/IG/28
21/01/2011 Centralised - Variation EMEA/H/C/716/IG/32/G
Updated with Decision(2011)5577 of 27/07/2011
03/02/2011 Centralised - Variation (2011)695 of 01/02/2011
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/716/WS/88/G
29/07/2011 Centralised - Variation EMEA/H/C/716/WS/100/G (2011)5577 of 27/07/2011
24/11/2011 Centralised - Renewal EMEA/H/C/716/R/48 (2011)8669 of 22/11/2011
03/07/2012 Centralised - Variation EMEA/H/C/716/WS/251/G (2012)4596 of 28/06/2012
03/09/2012 Centralised - Variation EMEA/H/C/716/WS/248/G (2012)6123 of 30/08/2012
31/10/2012 Centralised - Variation EMEA/H/C/716/WS/249/G (2012)7851 of 29/10/2012
05/08/2013 Centralised - 2-Monthly update EMEA/H/C/716/WS/360 (2013)5145 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/716/WS/461
Updated with Decision(2014)6376 of 04/09/2014
20/03/2014 Centralised - Variation EMEA/H/C/716/II/516
Updated with Decision(2014)6376 of 04/09/2014
08/09/2014 Referral EMEA/H/C/716/A-31/1370 (2014)6376 of 04/09/2014
16/12/2014 Centralised - Variation EMEA/H/C/716/IG/514