Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Dafiro   
Auth. number : EU/1/06/371
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.Dafiro 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/776 (2007)172 of 16/01/2007
03/04/2007 Centralised - Variation EMEA/H/C/776/IA/3
03/04/2007 Centralised - Variation EMEA/H/C/776/IA/1
03/04/2007 Centralised - Variation EMEA/H/C/776/IA/2
27/04/2007 Centralised - Variation EMEA/H/C/776/IA/4
18/07/2007 Centralised - Variation EMEA/H/C/776/IB/6
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/14
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/15
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/13
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/12
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/11
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/10
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/9
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/7
Updated with Decision(2008)2512 of 02/06/2008
14/09/2007 Centralised - Variation EMEA/H/C/776/IA/8
Updated with Decision(2008)2512 of 02/06/2008
24/09/2007 Centralised - Variation EMEA/H/C/776/IA/16
15/01/2008 Centralised - Variation EMEA/H/C/776/IB/17
Updated with Decision(2008)2512 of 02/06/2008
06/05/2008 Centralised - Variation EMEA/H/C/776/IA/22
Updated with Decision(2009)1124 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/776/IA/23
Updated with Decision(2009)1124 of 13/02/2009
06/05/2008 Centralised - Variation EMEA/H/C/776/IA/21
Updated with Decision(2009)1124 of 13/02/2009
28/05/2008 Centralised - Variation EMEA/H/C/776/N/20
Updated with Decision(2009)1124 of 13/02/2009
30/05/2008 Centralised - Variation EMEA/H/C/776/IA/24
04/06/2008 Centralised - Variation (2008)2512 of 02/06/2008
12/06/2008 Centralised - Variation EMEA/H/C/776/II/19 (2008)2732 of 10/06/2008
30/06/2008 Centralised - Variation EMEA/H/C/776/IA/26
07/07/2008 Centralised - Variation EMEA/H/C/776/IB/25
07/07/2008 Centralised - Variation EMEA/H/C/776/IA/27
10/07/2008 Centralised - Variation EMEA/H/C/776/IA/30
23/10/2008 Centralised - Variation EMEA/H/C/776/IA/33
23/10/2008 Centralised - Variation EMEA/H/C/776/IA/34
31/10/2008 Centralised - Variation EMEA/H/C/776/IB/32
17/02/2009 Centralised - Variation EMEA/H/C/776/II/31 (2009)1124 of 13/02/2009
24/02/2009 Centralised - Variation EMEA/H/C/776/IA/36
17/03/2009 Centralised - Variation EMEA/H/C/776/IB/37
01/04/2009 Centralised - Variation EMEA/H/C/776/II/35 (2009)2467 of 27/03/2009
30/07/2009 Centralised - Variation EMEA/H/C/776/IA/40
30/07/2009 Centralised - Variation EMEA/H/C/776/IA/39
17/08/2009 Centralised - Variation EMEA/H/C/776/IA/41
05/10/2009 Centralised - Variation EMEA/H/C/776/II/38
26/11/2009 Centralised - Variation EMEA/H/C/776/II/42
30/11/2009 Centralised - Variation EMEA/H/C/776/IA/45
30/11/2009 Centralised - Variation EMEA/H/C/776/IB/43
Updated with Decision(2010)1660 of 11/03/2010
08/12/2009 Centralised - Variation EMEA/H/C/776/IA/44
15/03/2010 Centralised - Variation (2010)1660 of 11/03/2010
23/03/2010 Centralised - Variation EMEA/H/C/776/II/46 (2010)1946 of 19/03/2010
14/06/2010 Centralised - Variation EMEA/H/C/776/IA/47/G
Updated with Decision(2011)467 of 24/01/2011
30/06/2010 Centralised - Variation EMEA/H/C/776/IB/48/G
15/11/2010 Centralised - Variation EMEA/H/C/775/IG/28
03/01/2011 Centralised - Variation EMEA/H/C/776/N/49
Updated with Decision(2011)467 of 24/01/2011
18/01/2011 Centralised - Variation EMEA/H/C/776/IG/32/G
Updated with Decision(2011)2627 of 08/04/2011
27/01/2011 Centralised - Variation (2011)467 of 24/01/2011
24/02/2011 Centralised - Variation EMEA/H/C/776/WS/88/G
12/04/2011 Centralised - Variation (2011)2627 of 08/04/2011
01/08/2011 Centralised - Variation EMEA/H/C/776/II/100/G (2011)5590 of 27/07/2011
22/11/2011 Centralised - Renewal EMEA/H/C/776/R/50 (2011)8641 of 21/11/2011
03/07/2012 Centralised - Variation EMEA/H/C/776/WS/251/G (2012)4572 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/776/WS/248/G (2012)6001 of 23/08/2012
29/10/2012 Centralised - Variation EMEA/H/C/776/WS/249/G (2012)7712 of 25/10/2012
02/08/2013 Centralised - Variation EMEA/H/C/776/WS/360 (2013)5131 of 31/07/2013
21/11/2013 Centralised - Variation EMEA/H/C/776/WS/461
Updated with Decision(2014)6366 of 04/09/2014
20/03/2014 Centralised - Variation EMEA/H/C/776/WS/516
Updated with Decision(2014)6366 of 04/09/2014
08/09/2014 Referral EMEA/H/A-31/1370/C/716/67 (2014)6366 of 04/09/2014