Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kinzalmono   
Auth. number : EU/1/98/091
Active substance : telmisartan
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09C - Angiotensin II antagonists, plain
Chemical subgroup: C09CA - Angiotensin II antagonists, plain
Chemical substance: C09CA07 - Telmisartan
(See WHO ATC Index)
Indication: Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in patients with:
i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
ii) type 2 diabetes mellitus with documented target organ damage
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
21/12/1998 Centralised - Authorisation EMEA/H/C/211 (1998)4330 of 16/12/1998
10/06/1999 Centralised - Notification EMEA/H/C/211/N/4 (1998)4330 of 03/06/1999
14/09/1999 Centralised - Authorisation EMEA/H/C/211/X/1 (1999)2868 of 07/09/1999
22/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/10
14/03/2000 Centralised - Variation EMEA/H/C/211/I/6 (2000)604 of 09/03/2000
30/03/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/8, 9, 11 ,12
03/04/2000 Centralised - Notification EMEA/H/C/211/N/4 (2000)882 of 30/03/2000
20/07/2000 Centralised - Variation EMEA/H/C/211/II/15 (2000)2033 of 13/07/2000
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/18
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/16
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/17
17/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/19
20/01/2001 Centralised - Variation EMEA/H/C/211/II/20 (2001)77 of 22/01/2001
11/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/21
22/10/2001 Centralised - Variation EMEA/H/C/211/I/22 (2001)2870 of 19/10/2001
22/10/2001 Centralised - Variation EMEA/H/C/211/I/23 (2001)2870 of 19/10/2001
30/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/26
03/06/2002 Centralised - Variation EMEA/H/C/211/II/24 (2002)2052 of 30/05/2002
04/10/2002 Centralised - Notification EMEA/H/C/211/N/27 (2002)3709 of 02/10/2002
04/12/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/211/T/28 (2002)4902 of 02/12/2002
23/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/33
23/04/2003 Centralised - Variation EMEA/H/C/211/I/29, 30, 31 (2003)1381 of 16/04/2003
23/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/32
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/35
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/34
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/37
27/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/36
09/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/38
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/I/39
13/01/2004 Centralised - Renewal EMEA/H/C/211/R/40 (2004)62 of 09/01/2004
28/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/42
08/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/44
08/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/45
05/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/46
09/12/2004 Centralised - Variation EMEA/H/C/211/II/43 (2004)4891 of 07/12/2004
21/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/47
21/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/48
24/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/II/49
07/02/2006 Centralised - Variation EMEA/H/C/211/IA/50
Updated with Decision(2006)1041 of 22/03/2006
24/03/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/211/T/51 (2006)1041 of 22/03/2006
10/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/52
28/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/55
10/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/57
20/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/58
09/01/2007 Centralised - Variation EMEA/H/C/211/II/54 (2007)25 of 04/01/2007
05/03/2007 Centralised - Variation EMEA/H/C/211/II/53 (2007)757 of 01/03/2007
04/07/2007 Centralised - Notification EMEA/H/C/211/N/59
Updated with Decision(2008)3503 of 04/07/2008
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/68
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/65
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/64
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/67
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/63
28/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/66
08/07/2008 Centralised - Variation EMEA/H/C/211/II/61 (2008)3503 of 04/07/2008
18/07/2008 Centralised - Notification EMEA/H/C/211/N/62
Updated with Decision(2008)7393 of 19/11/2008
19/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/70
21/11/2008 Centralised - Renewal EMEA/H/C/211/R/69 (2008)7393 of 19/11/2008
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/74
20/03/2009 Centralised - Variation EMEA/H/C/211/II/73 (2009)2093 of 18/03/2009
21/04/2009 Centralised - Variation EMEA/H/C/211/IA/77
Updated with Decision(2009)3735 of 05/05/2009
22/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/78
07/05/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/211/T/76 (2009)3735 of 05/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/211/II/71 (2009)4347 of 29/05/2009
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/79
25/11/2009 Centralised - Variation EMEA/H/C/211/II/72 (2009)9455 of 23/11/2009
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/83
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/81
21/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IB/82
18/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/211/IA/84
02/03/2011 Centralised - Variation EMEA/H/C/211/WS/40 (2011)1475 of 28/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/211/WS/102 (2011)3091 of 02/05/2011
25/08/2011 Centralised - Variation EMEA/H/C/211/IG/94/G
Updated with Decision(2012)2330 of 30/03/2012
04/04/2012 Centralised - Variation (2012)2330 of 30/03/2012
31/05/2012 Centralised - Variation EMEA/H/C/211/WS/220 (2012)3601 of 25/05/2012
02/01/2013 Centralised - Variation EMEA/H/C/211/WS/254 (2012)9939 of 20/12/2012
03/06/2013 Centralised - 2-Monthly update EMEA/H/C/211/WS/362 (2013)3372 of 30/05/2013
07/10/2013 Centralised - Notification EMEA/H/C/211/N/96
Updated with Decision(2014)6401 of 04/09/2014
18/12/2013 Centralised - Variation EMEA/H/C/211/WS/468
Updated with Decision(2014)6401 of 04/09/2014
14/07/2014 Centralised - Notification EMEA/H/C/211/N/101
08/09/2014 Referral EMEA/H/A-31/1370/C/211/94 (2014)6401 of 04/09/2014