Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Competact   
Auth. number : EU/1/06/354
INN : Pioglitazone / metformin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD05 - Metformin and pioglitazone
(See WHO ATC Index)
Indication: Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequateresponse, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained
Marketing Authorisation Holder: Takeda Pharma A/S
PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

  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
01/08/2006 Centralised - Authorisation EMEA/H/C/655 (2006)3495 of 28/07/2006
08/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IB/2
09/01/2007 Centralised - Variation EMEA/H/C/655/II/1 (2007)32 of 04/01/2007
09/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/5
17/01/2007 Centralised - Notification EMEA/H/C/655/N/3
Updated with Decision(2007)4006 of 20/08/2007
31/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IB/4
29/03/2007 Centralised - Notification EMEA/H/C/655/N/6
Updated with Decision(2007)4006 of 20/08/2007
11/07/2007 Centralised - Variation EMEA/H/C/655/IB/8
Updated with Decision(2007)5306 of 24/10/2007
12/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/9
12/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/11
12/07/2007 Centralised - Variation EMEA/H/C/655/IA/10
Updated with Decision(2007)5306 of 24/10/2007
22/08/2007 Centralised - Variation EMEA/H/C/655/II/7 (2007)4006 of 20/08/2007
24/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IB/14
26/10/2007 Centralised - Variation EMEA/H/C/655/II/12, 13 (2007)5306 of 24/10/2007
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/15
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/16
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IA/18
17/02/2009 Centralised - Variation EMEA/H/C/655/IA/21
Updated with Decision(2009)6621 of 21/08/2009
06/04/2009 Centralised - Notification EMEA/H/C/655/N/20
Updated with Decision(2009)6621 of 21/08/2009
25/08/2009 Centralised - Variation EMEA/H/C/655/II/22, 23 (2009)6621 of 21/08/2009
30/03/2010 Centralised - Variation EMEA/H/C/655/II/24 (2010)2167 of 26/03/2010
04/06/2010 Centralised - Variation EMEA/H/C/655/IB/25/G
Updated with Decision(2011)1181 of 21/02/2011
01/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/655/IB/26/G
23/02/2011 Centralised - Variation (2011)1181 of 21/02/2011
04/03/2011 Centralised - Variation EMEA/H/C/655/IA/29
Updated with Decision(2011)3865 of 27/05/2011
08/04/2011 Centralised - Notification EMEA/H/C/655/N/27
Updated with Decision(2011)3865 of 27/05/2011
01/06/2011 Centralised - Renewal EMEA/H/C/655/R/28 (2011)3865 of 27/05/2011
29/12/2011 Referral EMEA/H/C/655/A-20/30 (2011)10117 of 22/12/2011
03/01/2012 Referral EMEA/H/C/655/A-20/30 (2011)10116 of 22/12/2011
24/12/2012 Centralised - Variation EMEA/H/C/655/WS/324 (2012)9933 of 20/12/2012
19/04/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/655/T/40 (2013)2301 of 17/04/2013
14/11/2013 Centralised - Modification EMEA/H/C/655/PSUV/43 (2013)8090 of 13/11/2013
23/07/2014 Centralised - Variation EMEA/H/C/655/IB/47/G