Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kinzalkomb   
Auth. number : EU/1/02/214
INN : Telmisartan / hydrochlorothiazide
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: C09DA - Angiotensin II antagonists and diuretics
Chemical substance: C09DA07 - Telmisartan and diuretics
(See WHO ATC Index)
Indication: Treatment of essential hypertension.Kinzalkomb fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland

  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
23/04/2002 Centralised - Authorisation EMEA/H/C/415 (2002)1570 of 19/04/2002
09/12/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/415/T/1 (2002)4962 of 04/12/2002
11/03/2003 Centralised - Variation EMEA/H/C/415/I/2
10/04/2003 Centralised - Variation EMEA/H/C/415/I/3
24/04/2003 Centralised - Variation EMEA/H/C/415/I/4, 5, 6 (2003)1404 of 22/04/2003
28/05/2003 Centralised - Variation EMEA/H/C/415/I/7
25/06/2003 Centralised - Variation EMEA/H/C/415/I/8
26/06/2003 Centralised - Variation EMEA/H/C/415/I/9
09/07/2003 Centralised - Variation EMEA/H/C/415/I/11
24/07/2003 Centralised - Variation EMEA/H/C/415/I/10
25/07/2003 Centralised - Variation EMEA/H/C/415/I/12
02/04/2004 Centralised - Variation EMEA/H/C/415/IB/13
04/08/2004 Centralised - Variation EMEA/H/C/415/N/14
Updated with Decision(2005)6005 of 23/12/2005
08/09/2004 Centralised - Variation EMEA/H/C/415/IA/16
08/09/2004 Centralised - Variation EMEA/H/C/415/IA/15
08/11/2004 Centralised - Variation EMEA/H/C/415/IA/18
10/11/2004 Centralised - Variation EMEA/H/C/415/IB/17
15/04/2005 Centralised - Variation EMEA/H/C/415/IB/21
15/04/2005 Centralised - Variation EMEA/H/C/415/IB/20
Updated with Decision(2005)6005 of 23/12/2005
01/06/2005 Centralised - Variation EMEA/H/C/415/II/19
30/06/2005 Centralised - Variation EMEA/H/C/415/II/22
29/12/2005 Centralised - Variation (2005)6005 of 23/12/2005
07/02/2006 Centralised - Variation EMEA/H/C/415/IA/25
Updated with Decision(2006)1035 of 22/03/2006
01/03/2006 Centralised - Variation EMEA/H/C/415/II/24
24/03/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/415/T/26 (2006)1035 of 22/03/2006
11/05/2006 Centralised - Variation EMEA/H/C/415/IA/27
12/05/2006 Centralised - Variation EMEA/H/C/415/II/28
12/06/2006 Centralised - Variation EMEA/H/C/415/IA/29
28/09/2006 Centralised - Variation EMEA/H/C/415/IA/32
13/10/2006 Centralised - Variation EMEA/H/C/415/IA/34
13/10/2006 Centralised - Variation EMEA/H/C/415/IA/33
10/11/2006 Centralised - Variation EMEA/H/C/415/IB/36
18/12/2006 Centralised - Variation EMEA/H/C/415/IB/38
09/01/2007 Centralised - Variation EMEA/H/C/415/II/31 (2007)38 of 04/01/2007
07/03/2007 Centralised - Variation EMEA/H/C/415/II/30 (2007)793 of 05/03/2007
25/04/2007 Centralised - Renewal EMEA/H/C/415/R/37 (2007)1878 of 23/04/2007
20/08/2007 Centralised - Variation EMEA/H/C/415/N/40
Updated with Decision(2008)1248 of 27/03/2008
07/01/2008 Centralised - Variation EMEA/H/C/415/IB/42
30/01/2008 Centralised - Variation EMEA/H/C/415/II/41
31/03/2008 Centralised - Variation EMEA/H/C/415/X/39 (2008)1248 of 27/03/2008
28/05/2008 Centralised - Variation EMEA/H/C/415/IA/44
28/05/2008 Centralised - Variation EMEA/H/C/415/IA/47
28/05/2008 Centralised - Variation EMEA/H/C/415/IA/45
28/05/2008 Centralised - Variation EMEA/H/C/415/IA/46
07/07/2008 Centralised - Variation EMEA/H/C/415/II/43 (2008)3462 of 03/07/2008
04/08/2008 Centralised - Variation EMEA/H/C/415/N/48
Updated with Decision(2009)649 of 29/01/2009
02/02/2009 Centralised - Variation EMEA/H/C/415/II/49 (2009)649 of 29/01/2009
20/03/2009 Centralised - Variation EMEA/H/C/415/II/52 (2009)2094 of 18/03/2009
09/04/2009 Centralised - Variation EMEA/H/C/415/II/51 (2009)2869 of 07/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/415/IA/55
Updated with Decision(2009)3736 of 05/05/2009
22/04/2009 Centralised - Variation EMEA/H/C/415/IA/56
08/05/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/415/T/54 (2009)3736 of 05/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/415/II/50 (2009)4350 of 29/05/2009
14/08/2009 Centralised - Variation EMEA/H/C/415/IA/58
15/10/2009 Centralised - Variation EMEA/H/C/415/II/57 (2009)7961 of 13/10/2009
19/10/2009 Centralised - Variation EMEA/H/C/415/IA/60
09/12/2009 Centralised - Variation EMEA/H/C/415/IA/62
09/12/2009 Centralised - Variation EMEA/H/C/415/IA/63
09/12/2009 Centralised - Variation EMEA/H/C/415/IB/61
09/12/2009 Centralised - Variation EMEA/H/C/415/IA/64
29/04/2010 Centralised - Variation EMEA/H/C/415/II/65 (2010)2849 of 27/04/2010
07/06/2010 Centralised - Variation EMEA/H/C/415/IA/66
06/07/2010 Centralised - Variation EMEA/H/C/415/IG/10/G
08/02/2011 Centralised - Variation EMEA/H/C/415/IG/45/G
02/03/2011 Centralised - Variation EMEA/H/C/415/WS/39 (2011)1478 of 28/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/415/WS/104 (2011)3090 of 02/05/2011
25/08/2011 Centralised - Variation EMEA/H/C/415/IG/94/G
Updated with Decision(2012)2382 of 03/04/2012
05/04/2012 Centralised - Variation (2012)2382 of 03/04/2012
31/05/2012 Centralised - Variation EMEA/H/C/415/WS/221 (2012)3604 of 25/05/2012
05/07/2012 Centralised - Variation EMEA/H/C/415/WS/247 (2012)4704 of 03/07/2012
26/10/2012 Centralised - Variation EMEA/H/C/415/WS/288 (2012)7665 of 24/10/2012
03/06/2013 Centralised - Variation EMEA/H/C/415/WS/362, 372 (2013)3371 of 30/05/2013
07/10/2013 Centralised - Variation EMEA/H/C/415/N/86
Updated with Decision(2014)6400 of 04/09/2014
24/10/2013 Centralised - Variation EMEA/H/C/415/WS/436
Updated with Decision(2014)6400 of 04/09/2014
14/07/2014 Centralised - Variation EMEA/H/C/415/N/92
08/09/2014 Referral EMEA/H/C/415/A-31 (2014)6400 of 04/09/2014