Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Actos   
Auth. number : EU/1/00/150
INN : pioglitazone
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: A10BG - Thiazolidinediones
Chemical substance: A10BG03 - Pioglitazone
(See WHO ATC Index)
Indication: Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
as monotherapy
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
as dual oral therapy in combination with
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
as triple oral therapy in combination with
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
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 adequate response, 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
Dybendal Alle 10, 2630 Taastrup, 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
19/10/2000 Centralised - Authorisation EMEA/H/C/285 (2000)2827 of 13/10/2000
08/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/2
08/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/1
21/02/2001 Centralised - Variation EMEA/H/C/285/I/3 (2001)241 of 16/02/2001
21/02/2002 Centralised - Variation EMEA/H/C/285/I/5 (2002)649 of 19/02/2002
16/04/2002 Centralised - Variation EMEA/H/C/285/II/6 (2002)1495 of 12/04/2002
12/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/4
29/11/2002 Centralised - Variation EMEA/H/C/285/I/8 (2002)4799 of 26/11/2002
15/12/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/9
19/03/2003 Centralised - Variation EMEA/H/C/285/II/7 (2003)842 of 17/03/2003
01/09/2003 Centralised - Variation EMEA/H/C/285/II/10, 11 (2003)3169 of 28/08/2003
18/09/2003 Centralised - Variation EMEA/H/C/285/X/12 (2003)3340 of 16/09/2003
20/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/15
11/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/16
29/11/2004 Centralised - Notification EMEA/H/C/285/N/14
Updated with Decision(2005)64 of 10/01/2005
12/01/2005 Centralised - Variation EMEA/H/C/285/II/13 (2005)64 of 10/01/2005
18/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IB/17
14/09/2005 Centralised - Variation EMEA/H/C/285/IA/19
Updated with Decision(2006)1329 of 29/03/2006
18/10/2005 Centralised - Renewal EMEA/H/C/285/R/18 (2005)4084 of 13/10/2005
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/20
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/22
19/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IB/21
27/02/2006 Centralised - Variation EMEA/H/C/285/IA/27
Updated with Decision(2006)1329 of 29/03/2006
31/03/2006 Centralised - Variation (2006)1329 of 29/03/2006
19/05/2006 Centralised - Variation EMEA/H/C/285/IA/28
Updated with Decision(2006)3382 of 20/07/2006
26/07/2006 Centralised - Variation EMEA/H/C/285/II/26 (2006)3382 of 20/07/2006
04/09/2006 Centralised - Notification EMEA/H/C/285/N/30
Updated with Decision(2006)5203 of 26/10/2006
30/10/2006 Centralised - Variation EMEA/H/C/285/II/24, 29 (2006)5203 of 26/10/2006
08/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IB/31
30/01/2007 Centralised - Variation EMEA/H/C/285/II/23 (2007)312 of 26/01/2007
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IB/32
22/08/2007 Centralised - Variation EMEA/H/C/285/II/33 (2007)4004 of 20/08/2007
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/35
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/I/34
13/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/36
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IA/37
16/02/2009 Centralised - Variation EMEA/H/C/285/IA/39
Updated with Decision(2009)7139 of 17/09/2009
03/04/2009 Centralised - Notification EMEA/H/C/285/N/38
Updated with Decision(2009)7139 of 17/09/2009
21/09/2009 Centralised - Variation EMEA/H/C/285/II/41 (2009)7139 of 17/09/2009
01/04/2010 Centralised - Variation EMEA/H/C/285/II/42 (2010)2252 of 30/03/2010
04/06/2010 Centralised - Variation EMEA/H/C/285/IB/44/G
Updated with Decision(2010)6090 of 31/08/2010
02/09/2010 Centralised - Renewal EMEA/H/C/285/R/43 (2010)6090 of 31/08/2010
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/285/IB/45/G
18/07/2011 Centralised - Notification EMEA/H/C/285/N/47
Updated with Decision(2011)10105 of 22/12/2011
29/12/2011 Referral EMEA/H/C/285/A-20/46 (2011)10105 of 22/12/2011
29/12/2011 Referral EMEA/H/C/285/A-20/46 (2011)10106 of 22/12/2011
20/12/2012 Centralised - Variation EMEA/H/C/285/WS/324 (2012)9872 of 18/12/2012
01/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/285/T/54 (2013)2648 of 29/04/2013
15/11/2013 Centralised - Modification EMEA/H/C/285/PSUV/58 (2013)8078 of 13/11/2013
16/06/2014 Centralised - Variation EMEA/H/C/285/IB/62/G