Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pritor   
Auth. number : EU/1/98/089
INN : 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 adults with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
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
16/12/1998 Centralised - Authorisation EMEA/H/C/210 (1998)4288 of 11/12/1998
30/06/1999 Centralised - Variation EMEA/H/C/210/N/4 (1999)1651 of 18/06/1999
23/09/1999 Centralised - Authorisation EMEA/H/C/210/X/1 (1999)3009 of 15/09/1999
09/02/2000 Centralised - Variation EMEA/H/C/210/I/10
14/03/2000 Centralised - Variation EMEA/H/C/210/I/6 (2000)603 of 09/03/2000
27/03/2000 Centralised - Variation EMEA/H/C/210/I/8, 9, 11, 12
03/08/2000 Centralised - Variation EMEA/H/C/210/II/14 (2000)2328 of 27/07/2000
11/10/2000 Centralised - Variation EMEA/H/C/210/I/15
11/10/2000 Centralised - Variation EMEA/H/C/210/I/16
11/10/2000 Centralised - Variation EMEA/H/C/210/I/17
11/10/2000 Centralised - Variation EMEA/H/C/210/I/18
06/02/2001 Centralised - Variation EMEA/H/C/210/II/19 (2001)207 of 02/02/2001
11/05/2001 Centralised - Variation EMEA/H/C/210/I/20
17/10/2001 Centralised - Variation EMEA/H/C/210/I/21, 22 (2001)2850 of 16/10/2001
05/06/2002 Centralised - Variation EMEA/H/C/210/II/23 (2002)2051 of 30/05/2002
07/06/2002 Centralised - Variation EMEA/H/C/210/I/25
27/08/2002 Centralised - Variation EMEA/H/C/210/N/26 (2002)3178 of 22/08/2002
13/12/2002 Centralised - Variation EMEA/H/C/210/I/27 (2002)5158 of 11/12/2002
10/03/2003 Centralised - Variation EMEA/H/C/210/N/28 (2003)776 of 06/03/2003
26/03/2003 Centralised - Variation EMEA/H/C/210/I/29
02/05/2003 Centralised - Variation EMEA/H/C/210/I/31
02/05/2003 Centralised - Variation EMEA/H/C/210/I/30
26/06/2003 Centralised - Variation EMEA/H/C/210/I/32, 33, 35
26/06/2003 Centralised - Variation EMEA/H/C/210/I/34
08/07/2003 Centralised - Variation EMEA/H/C/210/I/37
23/07/2003 Centralised - Variation EMEA/H/C/210/I/38
30/07/2003 Centralised - Variation EMEA/H/C/210/I/36 (2003)2816 of 28/07/2003
20/12/2003 Centralised - Variation EMEA/H/C/210/IA/40
13/01/2004 Centralised - Renewal EMEA/H/C/210/R/39 (2004)60 of 09/01/2004
18/02/2004 Centralised - Variation EMEA/H/C/210/IB/41
21/04/2004 Centralised - Variation EMEA/H/C/210/IA/42
28/06/2004 Centralised - Variation EMEA/H/C/210/IA/43
08/10/2004 Centralised - Variation EMEA/H/C/210/IB/45
09/12/2004 Centralised - Variation EMEA/H/C/210/II/44 (2004)4893 of 07/12/2004
21/12/2004 Centralised - Variation EMEA/H/C/210/IB/46
21/12/2004 Centralised - Variation EMEA/H/C/210/IB/47
03/08/2005 Centralised - Variation EMEA/H/C/210/IA/48
Updated with Decision(2006)560 of 17/02/2006
24/11/2005 Centralised - Variation EMEA/H/C/210/II/49
29/11/2005 Centralised - Variation EMEA/H/C/210/IA/50
Updated with Decision(2006)560 of 17/02/2006
02/02/2006 Centralised - Variation EMEA/H/C/210/IA/53
06/02/2006 Centralised - Variation EMEA/H/C/210/IA/52
06/02/2006 Centralised - Variation EMEA/H/C/210/IA/51
Updated with Decision(2006)1036 of 22/03/2006
21/02/2006 Centralised - Variation (2006)560 of 17/02/2006
21/03/2006 Centralised - Variation EMEA/H/C/210/IA/55
Updated with Decision(2006)5239 of 27/10/2006
24/03/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/210/T/54 (2006)1036 of 22/03/2006
17/10/2006 Centralised - Variation EMEA/H/C/210/IA/63
Updated with Decision(2007)67 of 08/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/210/IA/61
Updated with Decision(2007)67 of 08/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/210/IA/62
Updated with Decision(2007)67 of 08/01/2007
31/10/2006 Centralised - Variation (2006)5239 of 27/10/2006
10/11/2006 Centralised - Variation EMEA/H/C/210/IB/65
20/12/2006 Centralised - Variation EMEA/H/C/210/IB/66
10/01/2007 Centralised - Variation EMEA/H/C/210/II/60 (2007)67 of 08/01/2007
31/01/2007 Centralised - Variation EMEA/H/C/210/II/64
01/03/2007 Centralised - Variation EMEA/H/C/210/II/59 (2007)711 of 27/02/2007
04/07/2007 Centralised - Variation EMEA/H/C/210/N/67
Updated with Decision(2008)3442 of 02/07/2008
30/08/2007 Centralised - Variation EMEA/H/C/210/IA/68
03/06/2008 Centralised - Variation EMEA/H/C/210/IA/72, 73, 74, 75, 76, 77, 78
04/07/2008 Centralised - Variation EMEA/H/C/210/II/70 (2008)3442 of 02/07/2008
18/07/2008 Centralised - Variation EMEA/H/C/210/N/71
Updated with Decision(2008)7396 of 19/11/2008
02/10/2008 Centralised - Variation EMEA/H/C/210/II/69
21/11/2008 Centralised - Renewal EMEA/H/C/210/R/79 (2008)7396 of 19/11/2008
26/11/2008 Centralised - Variation EMEA/H/C/210/IA/80
09/12/2008 Centralised - Variation EMEA/H/C/210/IA/82
Updated with Decision(2009)2068 of 17/03/2009
09/12/2008 Centralised - Variation EMEA/H/C/210/IA/81
Updated with Decision(2009)2068 of 17/03/2009
05/02/2009 Centralised - Variation EMEA/H/C/210/IA/86
19/03/2009 Centralised - Variation EMEA/H/C/210/II/85 (2009)2068 of 17/03/2009
21/04/2009 Centralised - Variation EMEA/H/C/210/IA/89
Updated with Decision(2009)3779 of 06/05/2009
08/05/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/210/T/88 (2009)3779 of 06/05/2009
28/05/2009 Centralised - Variation EMEA/H/C/210/II/83 (2009)4218 of 26/05/2009
14/08/2009 Centralised - Variation EMEA/H/C/210/IA/91
25/11/2009 Centralised - Variation EMEA/H/C/210/II/84 (2009)9445 of 23/11/2009
03/12/2009 Centralised - Variation EMEA/H/C/210/IA/92
09/12/2009 Centralised - Variation EMEA/H/C/210/IA/94
10/02/2010 Centralised - Variation EMEA/H/C/210/IB/93
09/04/2010 Centralised - Variation EMEA/H/C/210/IA/95/G
18/06/2010 Centralised - Variation EMEA/H/C/210/IA/96
25/02/2011 Centralised - Variation EMEA/H/C/210/WS/40 (2011)1233 of 21/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/210/WS/102 (2011)3097 of 02/05/2011
25/08/2011 Centralised - Variation EMEA/H/C/210/IG/94/G
Updated with Decision(2012)1628 of 08/03/2012
12/03/2012 Centralised - Variation (2012)1628 of 08/03/2012
30/05/2012 Centralised - Variation EMEA/H/C/210/WS/220 (2012)3570 of 25/05/2012
20/12/2012 Centralised - Variation EMEA/H/C/210/WS/254 (2012)9863 of 18/12/2012
31/05/2013 Centralised - Variation EMEA/H/C/210/WS/362 (2013)3357 of 29/05/2013
07/10/2013 Centralised - Variation EMEA/H/C/210/N/108
11/12/2013 Centralised - Variation EMEA/H/C/210/IG/388
18/12/2013 Centralised - Variation EMEA/H/C/210/WS/468