Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Glustin   
Auth. number : EU/1/00/151
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
17/10/2000 Centralised - Authorisation EMEA/H/C/286 (2000)2810 of 10/10/2000
08/12/2000 Centralised - Variation EMEA/H/C/286/I/2
08/12/2000 Centralised - Variation EMEA/H/C/286/I/1
20/02/2001 Centralised - Variation EMEA/H/C/286/I/3 (2001)240 of 16/02/2001
16/04/2002 Centralised - Variation EMEA/H/C/286/II/5 (2002)1494 of 12/04/2002
12/11/2002 Centralised - Variation EMEA/H/C/286/I/4
16/12/2002 Centralised - Variation EMEA/H/C/286/I/7
19/03/2003 Centralised - Variation EMEA/H/C/286/II/6 (2003)843 of 17/03/2003
01/09/2003 Centralised - Variation EMEA/H/C/286/II/8, 9 (2003)3168 of 28/08/2003
18/09/2003 Centralised - Variation EMEA/H/C/286/X/10 (2003)3338 of 16/09/2003
20/10/2004 Centralised - Variation EMEA/H/C/286/IA/12
11/11/2004 Centralised - Variation EMEA/H/C/286/IA/13
12/01/2005 Centralised - Variation EMEA/H/C/286/II/11 (2005)63 of 10/01/2005
18/03/2005 Centralised - Variation EMEA/H/C/286/IB/14
14/09/2005 Centralised - Variation EMEA/H/C/286/IA/16
Updated with Decision(2006)1335 of 29/03/2006
18/10/2005 Centralised - Renewal EMEA/H/C/286/R/15 (2005)4085 of 13/10/2005
16/11/2005 Centralised - Variation EMEA/H/C/286/IA/17
16/11/2005 Centralised - Variation EMEA/H/C/286/IA/19
19/12/2005 Centralised - Variation EMEA/H/C/286/IB/18
27/02/2006 Centralised - Variation EMEA/H/C/286/IA/21
Updated with Decision(2006)1335 of 29/03/2006
31/03/2006 Centralised - Variation (2006)1335 of 29/03/2006
19/05/2006 Centralised - Variation EMEA/H/C/286/IA/22
Updated with Decision(2006)3383 of 20/07/2006
26/07/2006 Centralised - Variation EMEA/H/C/286/II/20 (2006)3383 of 20/07/2006
30/10/2006 Centralised - Variation EMEA/H/C/286/II/23 (2006)5206 of 26/10/2006
11/07/2007 Centralised - Variation EMEA/H/C/286/IA/31
Updated with Decision(2007)4186 of 31/08/2007
11/07/2007 Centralised - Variation EMEA/H/C/286/IA/30
Updated with Decision(2007)4186 of 31/08/2007
22/08/2007 Centralised - Variation EMEA/H/C/286/II/27 (2007)4005 of 20/08/2007
05/09/2007 Centralised - Variation EMEA/H/C/286/II/24, 25, 26 (2007)4186 of 31/08/2007
12/09/2007 Centralised - Variation EMEA/H/C/286/IA/33
Updated with Decision(2008)1353 of 04/04/2008
12/09/2007 Centralised - Variation EMEA/H/C/286/IA/34
15/10/2007 Centralised - Variation EMEA/H/C/286/IB/32
09/04/2008 Centralised - Variation (2008)1353 of 04/04/2008
30/06/2008 Centralised - Variation EMEA/H/C/286/N/35
Updated with Decision(2009)7141 of 17/09/2009
09/07/2008 Centralised - Variation EMEA/H/C/286/IA/36
15/12/2008 Centralised - Variation EMEA/H/C/286/N/37
Updated with Decision(2009)7141 of 17/09/2009
25/02/2009 Centralised - Variation EMEA/H/C/286/IA/38
Updated with Decision(2009)7141 of 17/09/2009
21/09/2009 Centralised - Variation EMEA/H/C/286/II/40 (2009)7141 of 17/09/2009
01/04/2010 Centralised - Variation EMEA/H/C/286/II/41 (2010)2253 of 30/03/2010
02/09/2010 Centralised - Renewal EMEA/H/C/286/R/42 (2010)6088 of 31/08/2010
14/09/2010 Centralised - Variation EMEA/H/C/286/IB/43/G
18/07/2011 Centralised - Variation EMEA/H/C/286/N/45
Updated with Decision(2011)10107 of 22/12/2011
29/12/2011 Referral EMEA/H/C/286/A-20/44 (2011)10108 of 22/12/2011
29/12/2011 Referral EMEA/H/C/286/A-20/44 (2011)10107 of 22/12/2011
20/12/2012 Centralised - Variation EMEA/H/C/286/WS/324 (2012)9875 of 18/12/2012
01/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/286/T/52 (2013)2647 of 29/04/2013
15/11/2013 Centralised - Modification EMEA/H/C/286/PSUV/56 (2013)8077 of 13/11/2013
16/06/2014 Centralised - Variation EMEA/H/C/286/IB/60/G