Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: MicardisPlus   
Auth. number : EU/1/02/213
INN : Telmisartan / hydrochlorothiazide
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: Treatment of essential hypertension.
MicardisPlus 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: 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
23/04/2002 Centralised - Authorisation EMEA/H/C/413 (2002)1564 of 19/04/2002
08/08/2002 Centralised - Notification EMEA/H/C/413/N/1 (2002)3073 of 05/08/2002
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/2
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/4
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/5
27/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/6
27/06/2003 Centralised - Variation EMEA/H/C/413/I/3 (2003)2082 of 25/06/2003
09/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/8
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/9
24/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/7
02/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/10
04/08/2004 Centralised - Notification EMEA/H/C/413/N/11
Updated with Decision(2005)6018 of 23/12/2005
08/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/13
10/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/12
01/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/14
15/04/2005 Centralised - Variation EMEA/H/C/413/IB/16
Updated with Decision(2005)6018 of 23/12/2005
15/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/17
01/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/II/15
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/II/18
05/01/2006 Centralised - Variation (2005)6018 of 23/12/2005
06/01/2006 Centralised - Variation EMEA/H/C/413/IA/20
Updated with Decision(2006)3007 of 26/06/2006
28/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/II/21
11/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/22
12/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/23
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/26
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/25
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/27
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/24
12/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/28
28/06/2006 Centralised - Variation (2006)3007 of 26/06/2006
13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/31
17/10/2006 Centralised - Variation EMEA/H/C/413/IA/33
Updated with Decision(2007)11 of 03/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/413/IA/32
Updated with Decision(2007)11 of 03/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/413/IA/35
Updated with Decision(2007)11 of 03/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/413/IA/34
Updated with Decision(2007)11 of 03/01/2007
10/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/I/B/37
18/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/39
09/01/2007 Centralised - Variation EMEA/H/C/413/II/30 (2007)11 of 03/01/2007
31/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/II/36
07/03/2007 Centralised - Variation EMEA/H/C/413/II/29 (2007)794 of 05/03/2007
25/04/2007 Centralised - Renewal EMEA/H/C/413/R/38 (2007)1879 of 23/04/2007
20/08/2007 Centralised - Notification EMEA/H/C/413/N/41
Updated with Decision(2008)1247 of 27/03/2008
07/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/43
30/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/II/42
31/03/2008 Centralised - Variation EMEA/H/C/413/X/40 (2008)1247 of 27/03/2008
08/07/2008 Centralised - Variation EMEA/H/C/413/II/44 (2008)3500 of 04/07/2008
29/01/2009 Centralised - Variation EMEA/H/C/413/II/45 (2009)589 of 27/01/2009
20/03/2009 Centralised - Variation EMEA/H/C/413/II/51 (2009)2094 of 18/03/2009
01/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/48
01/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/49
01/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IB/47
09/04/2009 Centralised - Variation EMEA/H/C/413/II/50 (2009)2877 of 07/04/2009
03/06/2009 Centralised - Variation EMEA/H/C/413/II/46 (2009)4341 of 29/05/2009
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/55
01/09/2009 Centralised - Variation EMEA/H/C/413/II/53 (2009)6721 of 28/08/2009
19/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/57
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/59
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/61
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/58
09/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/60
14/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/57
14/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/62
21/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/63
30/03/2010 Centralised - Variation EMEA/H/C/413/IA/65
Updated with Decision(2010)5319 of 27/07/2010
03/05/2010 Centralised - Variation EMEA/H/C/413/II/64 (2010)2839 of 27/04/2010
07/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IA/66
06/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/413/IG/10/G
29/07/2010 Centralised - Variation (2010)5319 of 27/07/2010
03/03/2011 Centralised - Variation EMEA/H/C/413/WS/39 (2011)1479 of 28/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/413/WS/104 (2011)3092 of 02/05/2011
21/12/2011 Centralised - Variation EMEA/H/C/413/IA/73/G
Updated with Decision(2012)3603 of 25/05/2012
31/05/2012 Centralised - Variation EMEA/H/C/413/WS/221 (2012)3603 of 25/05/2012
05/07/2012 Centralised - Variation EMEA/H/C/413/WS/247 (2012)4703 of 03/07/2012
12/07/2012 Centralised - Notification EMEA/H/C/413/N/80
Updated with Decision(2012)7664 of 24/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/413/WS/288 (2012)7664 of 24/10/2012
03/06/2013 Centralised - 2-Monthly update EMEA/H/C/413/WS/362, 372 (2013)3374 of 30/05/2013
07/10/2013 Centralised - Notification EMEA/H/C/413/N/86
Updated with Decision(2014)6373 of 04/09/2014
24/10/2013 Centralised - Variation EMEA/H/C/413/WS/436
Updated with Decision(2014)6373 of 04/09/2014
08/09/2014 Referral EMEA/H/C/413/A-31/1370 (2014)6373 of 04/09/2014