Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Micardis   
Auth. number : EU/1/98/090
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: HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) orii) type 2 diabetes mellitus with documented target organ damage
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, 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/209 (1998)4295 of 16/12/1998
17/06/1999 Centralised - Variation EMEA/H/C/209/N/4 (1999)1494 of 03/06/1999
14/09/1999 Centralised - Authorisation EMEA/H/C/209/X/1 (1999)2870 of 07/09/1999
22/02/2000 Centralised - Variation EMEA/H/C/209/I/10
14/03/2000 Centralised - Variation EMEA/H/C/209/I/6 (2000)588 of 09/03/2000
30/03/2000 Centralised - Variation EMEA/H/C/209/I/8, 9, 11, 12
03/04/2000 Centralised - Variation EMEA/H/C/209/N/14 (2000)880 of 30/03/2000
07/08/2000 Centralised - Variation EMEA/H/C/209/II/15 (2000)2369 of 01/08/2000
12/09/2000 Centralised - Variation EMEA/H/C/209/I/16
12/09/2000 Centralised - Variation EMEA/H/C/209/I/17
12/09/2000 Centralised - Variation EMEA/H/C/209/I/18
11/10/2000 Centralised - Variation EMEA/H/C/209/I/19
24/01/2001 Centralised - Variation EMEA/H/C/209/II/20 (2001)81 of 22/01/2001
11/05/2001 Centralised - Variation EMEA/H/C/209/I/21
22/10/2001 Centralised - Variation EMEA/H/C/209/I/23 (2001)2869 of 19/10/2001
22/10/2001 Centralised - Variation EMEA/H/C/209/I/22 (2001)2869 of 19/10/2001
30/05/2002 Centralised - Variation EMEA/H/C/209/I/26
03/06/2002 Centralised - Variation EMEA/H/C/209/II/24 (2002)2053 of 30/04/2002
02/10/2002 Centralised - Variation EMEA/H/C/209/N/27 (2002)3660 of 30/09/2002
24/10/2002 Centralised - Variation EMEA/H/C/209/I/28
05/02/2003 Centralised - Variation EMEA/H/C/209/N/29 (2003)467 of 03/02/2003
18/03/2003 Centralised - Variation EMEA/H/C/209/I/30
23/04/2003 Centralised - Variation EMEA/H/C/209/I/32
16/05/2003 Centralised - Variation EMEA/H/C/209/I/33
20/05/2003 Centralised - Variation EMEA/H/C/209/I/31 (2003)1705 of 16/05/2003
06/06/2003 Centralised - Variation EMEA/H/C/209/I/34
26/06/2003 Centralised - Variation EMEA/H/C/209/I/37
26/06/2003 Centralised - Variation EMEA/H/C/209/I/35
27/06/2003 Centralised - Variation EMEA/H/C/209/I/36
09/07/2003 Centralised - Variation EMEA/H/C/209/I/38
23/07/2003 Centralised - Variation EMEA/H/C/209/I/39
13/01/2004 Centralised - Renewal EMEA/H/C/209/R/40 (2004)61 of 09/01/2004
18/02/2004 Centralised - Variation EMEA/H/C/209/IB/41
18/03/2004 Centralised - Variation EMEA/H/C/209/IA/42
Updated with Decision(2004)4713 of 01/12/2004
28/06/2004 Centralised - Variation EMEA/H/C/209/IA/43
05/10/2004 Centralised - Variation EMEA/H/C/209/IB/45
03/12/2004 Centralised - Variation (2004)4713 of 01/12/2004
10/12/2004 Centralised - Variation EMEA/H/C/209/II/44 (2004)4892 of 07/12/2004
21/12/2004 Centralised - Variation EMEA/H/C/209/IB/47
21/12/2004 Centralised - Variation EMEA/H/C/209/IB/46
24/11/2005 Centralised - Variation EMEA/H/C/209/II/48
08/12/2005 Centralised - Variation EMEA/H/C/209/IA/49
Updated with Decision(2006)3006 of 26/06/2006
10/05/2006 Centralised - Variation EMEA/H/C/209/IA/50
08/06/2006 Centralised - Variation EMEA/H/C/209/IA/51
08/06/2006 Centralised - Variation EMEA/H/C/209/IA/52
12/06/2006 Centralised - Variation EMEA/H/C/209/IA/55
12/06/2006 Centralised - Variation EMEA/H/C/209/IA/53
12/06/2006 Centralised - Variation EMEA/H/C/209/IA/54
28/06/2006 Centralised - Variation (2006)3006 of 26/06/2006
17/10/2006 Centralised - Variation EMEA/H/C/209/IA/61
Updated with Decision(2007)29 of 04/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/209/IA/59
Updated with Decision(2007)29 of 04/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/209/IA/58
Updated with Decision(2007)29 of 04/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/209/IA/60
Updated with Decision(2007)29 of 04/01/2007
10/11/2006 Centralised - Variation EMEA/H/C/209/IB/63
20/12/2006 Centralised - Variation EMEA/H/C/209/IB/64
09/01/2007 Centralised - Variation EMEA/H/C/209/II/57 (2007)29 of 04/01/2007
10/01/2007 Centralised - Variation EMEA/H/C/209/IA/65
31/01/2007 Centralised - Variation EMEA/H/C/209/II/62
07/03/2007 Centralised - Variation EMEA/H/C/209/II/56 (2007)826 of 05/03/2007
04/07/2007 Centralised - Variation EMEA/H/C/209/N/66
Updated with Decision(2008)3461 of 03/07/2008
23/05/2008 Centralised - Variation EMEA/H/C/209/IA/70
23/05/2008 Centralised - Variation EMEA/H/C/209/IA/69
07/07/2008 Centralised - Variation EMEA/H/C/209/II/68 (2008)3461 of 03/07/2008
01/10/2008 Centralised - Variation EMEA/H/C/209/II/67
21/11/2008 Centralised - Renewal EMEA/H/C/209/R/71 (2008)7395 of 19/11/2008
12/02/2009 Centralised - Variation EMEA/H/C/209/IA/75
Updated with Decision(2009)2123 of 19/03/2009
23/03/2009 Centralised - Variation EMEA/H/C/209/II/74 (2009)2123 of 19/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/209/II/72 (2009)4346 of 29/05/2009
12/08/2009 Centralised - Variation EMEA/H/C/209/IA/78
26/11/2009 Centralised - Variation EMEA/H/C/209/II/73 (2009)9456 of 23/11/2009
09/12/2009 Centralised - Variation EMEA/H/C/209/IA/82
09/12/2009 Centralised - Variation EMEA/H/C/209/IA/81
09/12/2009 Centralised - Variation EMEA/H/C/209/IA/83
09/12/2009 Centralised - Variation EMEA/H/C/209/IA/79
14/12/2009 Centralised - Variation EMEA/H/C/209/IA/84
21/12/2009 Centralised - Variation EMEA/H/C/209/IA/85
21/01/2010 Centralised - Variation EMEA/H/C/209/IB/80
18/06/2010 Centralised - Variation EMEA/H/C/209/IA/86
02/03/2011 Centralised - Variation EMEA/H/C/209/WS/40 (2011)1476 of 28/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/209/WS/102 (2011)3092 of 02/05/2011
30/05/2011 Centralised - Variation EMEA/H/C/209/IB/87/G
Updated with Decision(2011)6142 of 24/08/2011
29/08/2011 Centralised - Variation (2011)6142 of 24/08/2011
10/02/2012 Centralised - Variation EMEA/H/C/209/IB/91/G
Updated with Decision(2012)3602 of 25/05/2012
31/05/2012 Centralised - Variation EMEA/H/C/209/WS/220 (2012)3602 of 25/05/2012
12/07/2012 Centralised - Variation EMEA/H/C/209/N/96
Updated with Decision(2012)9938 of 20/12/2012
27/12/2012 Centralised - Variation EMEA/H/C/209/WS/254 (2012)9938 of 20/12/2012
03/06/2013 Centralised - Variation EMEA/H/C/209/WS/362 (2013)3373 of 30/05/2013
07/10/2013 Centralised - Variation EMEA/H/C/209/N/100
18/12/2013 Centralised - Variation EMEA/H/C/209/WS/468