Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: PritorPlus   
Auth. number : EU/1/02/215
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.
PritorPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults 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
24/04/2002 Centralised - Authorisation EMEA/H/C/414 (2002)1581 of 22/04/2002
27/08/2002 Centralised - Variation EMEA/H/C/414/N/1 (2002)3183 of 22/08/2002
10/03/2003 Centralised - Variation EMEA/H/C/414/N/3 (2003)773 of 06/03/2003
13/03/2003 Centralised - Variation EMEA/H/C/414/I/2
26/05/2003 Centralised - Variation EMEA/H/C/414/I/5
26/06/2003 Centralised - Variation EMEA/H/C/414/I/6
26/06/2003 Centralised - Variation EMEA/H/C/414/I/7
08/07/2003 Centralised - Variation EMEA/H/C/414/I/9
22/07/2003 Centralised - Variation EMEA/H/C/414/I/8
22/07/2003 Centralised - Variation EMEA/H/C/414/I/10
22/07/2003 Centralised - Variation EMEA/H/C/414/I/8
05/04/2004 Centralised - Variation EMEA/H/C/414/IB/11
05/08/2004 Centralised - Variation EMEA/H/C/414/N/12
Updated with Decision(2006)75 of 13/01/2006
24/11/2004 Centralised - Variation EMEA/H/C/414/IB/13
24/11/2004 Centralised - Variation EMEA/H/C/414/IA/14
15/04/2005 Centralised - Variation EMEA/H/C/414/IB/16
Updated with Decision(2006)75 of 13/01/2006
15/04/2005 Centralised - Variation EMEA/H/C/414/IB/17
30/06/2005 Centralised - Variation EMEA/H/C/414/II/18
30/06/2005 Centralised - Variation EMEA/H/C/414/II/15
14/10/2005 Centralised - Variation EMEA/H/C/414/IA/19
29/11/2005 Centralised - Variation EMEA/H/C/414/IA/21
Updated with Decision(2006)1037 of 22/03/2006
17/01/2006 Centralised - Variation (2006)75 of 13/01/2006
03/02/2006 Centralised - Variation EMEA/H/C/414/IA/24
06/02/2006 Centralised - Variation EMEA/H/C/414/IA/23
Updated with Decision(2006)1037 of 22/03/2006
28/02/2006 Centralised - Variation EMEA/H/C/414/II/22
21/03/2006 Centralised - Variation EMEA/H/C/414/IA/26
Updated with Decision(2006)5114 of 20/10/2006
24/03/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/414/T/25 (2006)1037 of 22/03/2006
30/03/2006 Centralised - Variation EMEA/H/C/414/IA/27
11/05/2006 Centralised - Variation EMEA/H/C/414/IA/28
12/05/2006 Centralised - Variation EMEA/H/C/414/IA/30
12/06/2006 Centralised - Variation EMEA/H/C/414/IA/31
22/06/2006 Centralised - Variation EMEA/H/C/414/N/32
Updated with Decision(2006)5114 of 20/10/2006
13/10/2006 Centralised - Variation EMEA/H/C/414/IA/35
17/10/2006 Centralised - Variation EMEA/H/C/414/IA/36
Updated with Decision(2007)66 of 08/01/2007
17/10/2006 Centralised - Variation EMEA/H/C/414/IA/37
Updated with Decision(2007)66 of 08/01/2007
24/10/2006 Centralised - Variation (2006)5114 of 20/10/2006
10/11/2006 Centralised - Variation EMEA/H/C/414/IB/39
18/12/2006 Centralised - Variation EMEA/H/C/414/IB/41
10/01/2007 Centralised - Variation EMEA/H/C/414/II/34 (2007)66 of 08/01/2007
31/01/2007 Centralised - Variation EMEA/H/C/414/II/38
02/03/2007 Centralised - Variation EMEA/H/C/414/II/33 (2007)742 of 28/02/2007
16/05/2007 Centralised - Renewal EMEA/H/C/414/R/40 (2007)2142 of 14/05/2007
30/07/2007 Centralised - Variation EMEA/H/C/414/IA/44
20/08/2007 Centralised - Variation EMEA/H/C/414/N/43
Updated with Decision(2008)1304 of 01/04/2008
14/01/2008 Centralised - Variation EMEA/H/C/414/IB/46
29/01/2008 Centralised - Variation EMEA/H/C/414/II/45
03/04/2008 Centralised - Variation EMEA/H/C/414/X/42 (2008)1304 of 01/04/2008
09/04/2008 Centralised - Variation EMEA/H/C/414/IA/48
03/06/2008 Centralised - Variation EMEA/H/C/414/IA/49, 50, 51
03/06/2008 Centralised - Variation EMEA/H/C/414/IA/52
07/07/2008 Centralised - Variation EMEA/H/C/414/II/47 (2008)3439 of 02/07/2008
04/08/2008 Centralised - Variation EMEA/H/C/414/N/53
Updated with Decision(2009)592 of 27/01/2009
25/11/2008 Centralised - Variation EMEA/H/C/414/IA/56
Updated with Decision(2009)592 of 27/01/2009
25/11/2008 Centralised - Variation EMEA/H/C/414/IA/55
Updated with Decision(2009)592 of 27/01/2009
29/01/2009 Centralised - Variation EMEA/H/C/414/II/54 (2009)592 of 27/01/2009
19/03/2009 Centralised - Variation EMEA/H/C/414/II/59 (2009)2070 of 17/03/2009
09/04/2009 Centralised - Variation EMEA/H/C/411/II/58 (2009)2863 of 07/04/2009
20/04/2009 Centralised - Variation EMEA/H/C/414/IA/63
21/04/2009 Centralised - Variation EMEA/H/C/414/IA/62
Updated with Decision(2009)3778 of 06/05/2009
08/05/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/414/T/61 (2009)3778 of 06/05/2009
29/05/2009 Centralised - Variation EMEA/H/C/414/II/57 (2009)4238 of 27/05/2009
14/08/2009 Centralised - Variation EMEA/H/C/414/IA/66
02/09/2009 Centralised - Variation EMEA/H/C/414/IA/67
02/09/2009 Centralised - Variation EMEA/H/C/414/IA/68
16/10/2009 Centralised - Variation EMEA/H/C/414/II/64 (2009)8008 of 14/10/2009
19/10/2009 Centralised - Variation EMEA/H/C/414/IA/69
03/12/2009 Centralised - Variation EMEA/H/C/414/IA/72
03/12/2009 Centralised - Variation EMEA/H/C/414/IA/71
04/12/2009 Centralised - Variation EMEA/H/C/414/IB/70
09/12/2009 Centralised - Variation EMEA/H/C/414/IA/73
09/04/2010 Centralised - Variation EMEA/H/C/414/IA/75/G
03/05/2010 Centralised - Variation EMEA/H/C/414/II/74 (2010)2940 of 29/04/2010
07/06/2010 Centralised - Variation EMEA/H/C/414/IA/76
05/07/2010 Centralised - Variation EMEA/H/C/414/IG/10/G
28/02/2011 Centralised - Variation EMEA/H/C/414/WS/39 (2011)1212 of 21/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/414/WS/104 (2011)3098 of 02/05/2011
25/08/2011 Centralised - Variation EMEA/H/C/414/IG/94/G
Updated with Decision(2012)1629 of 08/03/2012
12/03/2012 Centralised - Variation (2012)1629 of 08/03/2012
30/05/2012 Centralised - Variation EMEA/H/C/414/WS/221 (2012)3571 of 25/05/2012
04/07/2012 Centralised - Variation EMEA/H/C/414/IB/WS/247 (2012)4581 of 28/06/2012
26/10/2012 Centralised - Variation EMEA/H/C/414/WS/288 (2012)7675 of 24/10/2012
31/05/2013 Centralised - Variation EMEA/H/C/414/WS/362, 372 (2013)3358 of 29/05/2013
07/10/2013 Centralised - Variation EMEA/H/C/414/N/95
24/10/2013 Centralised - Variation EMEA/H/C/414/WS/436
11/12/2013 Centralised - Variation EMEA/H/C/414/IG/388