Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Imprida   
Auth. number : EU/1/06/373
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
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
19/01/2007 Centralised - Authorisation EMEA/H/C/775 (2007)187 of 17/01/2007
03/04/2007 Centralised - Variation EMEA/H/C/775/IA/2
03/04/2007 Centralised - Variation EMEA/H/C/775/IA/1
03/04/2007 Centralised - Variation EMEA/H/C/775/IA/3
27/04/2007 Centralised - Variation EMEA/H/C/775/IA/4
18/07/2007 Centralised - Variation EMEA/H/C/775/IB/6
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/14
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/15
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/13
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/12
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/11
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/10
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/9
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/7
Updated with Decision(2008)2533 of 03/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/775/IA/8
Updated with Decision(2008)2533 of 03/06/2008
24/09/2007 Centralised - Variation EMEA/H/C/775/IA/16
15/01/2008 Centralised - Variation EMEA/H/C/775/IB/17
Updated with Decision(2008)2533 of 03/06/2008
06/05/2008 Centralised - Variation EMEA/H/C/775/IA/22
Updated with Decision(2009)1099 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/775/IA/20
Updated with Decision(2009)1099 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/775/IA/21
Updated with Decision(2009)1099 of 13/02/2009
05/06/2008 Centralised - Variation (2008)2533 of 03/06/2008
12/06/2008 Centralised - Variation EMEA/H/C/775/II/19 (2008)2740 of 10/06/2008
05/08/2008 Centralised - Variation EMEA/H/C/775/N/30
Updated with Decision(2009)1099 of 13/02/2009
23/10/2008 Centralised - Variation EMEA/H/C/775/IA/34
23/10/2008 Centralised - Variation EMEA/H/C/775/IA/33
31/10/2008 Centralised - Variation EMEA/H/C/775/IB/32
17/02/2009 Centralised - Variation EMEA/H/C/775/II/31 (2009)1099 of 13/02/2009
24/02/2009 Centralised - Variation EMEA/H/C/775/IA/36
17/03/2009 Centralised - Variation EMEA/H/C/775/IB/37
01/04/2009 Centralised - Variation EMEA/H/C/775/II/35 (2009)2465 of 27/03/2009
30/07/2009 Centralised - Variation EMEA/H/C/775/IA/39
13/08/2009 Centralised - Variation EMEA/H/C/775/IA/42
13/08/2009 Centralised - Variation EMEA/H/C/775/IA/41
07/10/2009 Centralised - Variation EMEA/H/C/775/II/38
30/11/2009 Centralised - Variation EMEA/H/C/775/IA/46
30/11/2009 Centralised - Variation EMEA/H/C/775/IB/44
Updated with Decision(2010)920 of 09/02/2010
02/12/2009 Centralised - Variation EMEA/H/C/775/II/43
08/12/2009 Centralised - Variation EMEA/H/C/775/IA/45
11/02/2010 Centralised - Variation (2010)920 of 09/02/2010
25/03/2010 Centralised - Variation EMEA/H/C/775/II/47 (2010)2018 of 23/03/2010
25/05/2010 Centralised - Variation EMEA/H/C/775/IA/48/G
Updated with Decision(2011)694 of 01/02/2011
29/06/2010 Centralised - Variation EMEA/H/C/775/IB/49/G
15/11/2010 Centralised - Variation EMEA/H/C/775/IG/28
21/01/2011 Centralised - Variation EMEA/H/C/775/IG/32/G
Updated with Decision(2011)5578 of 27/07/2011
03/02/2011 Centralised - Variation (2011)694 of 01/02/2011
24/02/2011 Centralised - Variation EMEA/H/C/775/WS/88/G
29/07/2011 Centralised - Variation EMEA/H/C/775/WS/100 (2011)5578 of 27/07/2011
24/11/2011 Centralised - Renewal EMEA/H/C/775/R/50 (2011)8668 of 22/11/2011
03/07/2012 Centralised - Variation EMEA/H/C/775/WS/251/G (2012)4595 of 28/06/2012
03/09/2012 Centralised - Variation EMEA/H/C/775/WS/248/G (2012)6124 of 30/08/2012
31/10/2012 Centralised - Variation EMEA/H/C/775/WS/249/G (2012)7852 of 29/10/2012
05/08/2013 Centralised - Variation EMEA/H/C/775/WS/360 (2013)5146 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/775/WS/461
Updated with Decision(2014)6370 of 04/09/2014
20/03/2014 Centralised - Variation EMEA/H/C/775/WS/516
Updated with Decision(2014)6370 of 04/09/2014
08/09/2014 Referral EMEA/H/C/775/A-31/1370 (2014)6370 of 04/09/2014