Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Glubrava   
Auth. number : EU/1/07/421
INN : Pioglitazone / metformin hydrochloride
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: Glubrava is indicated as second line treatment of type 2 diabetes mellitus adult 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 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
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
13/12/2007 Centralised - Authorisation EMEA/H/C/893 (2007)6414 of 11/12/2007
01/02/2008 Centralised - Variation EMEA/H/C/893/IB/1
Updated with Decision(2008)5220 of 15/09/2008
28/03/2008 Centralised - Variation EMEA/H/C/893/IA/4
28/03/2008 Centralised - Variation EMEA/H/C/893/IA/2
28/03/2008 Centralised - Variation EMEA/H/C/893/IA/3
09/07/2008 Centralised - Variation EMEA/H/C/893/IA/6
09/07/2008 Centralised - Variation EMEA/H/C/893/IA/6
04/08/2008 Centralised - Variation EMEA/H/C/893/N/5
Updated with Decision(2009)7146 of 17/09/2009
17/09/2008 Centralised - Variation (2008)5220 of 15/09/2008
15/12/2008 Centralised - Variation EMEA/H/C/893/N/7
Updated with Decision(2009)7146 of 17/09/2009
12/02/2009 Centralised - Variation EMEA/H/C/893/IA/9
Updated with Decision(2009)7146 of 17/09/2009
21/09/2009 Centralised - Variation EMEA/H/C/893/II/10, 11 (2009)7146 of 17/09/2009
01/04/2010 Centralised - Variation EMEA/H/C/893/II/12 (2010)2254 of 30/03/2010
14/09/2010 Centralised - Variation EMEA/H/C/893/IB/13/G
29/12/2011 Referral EMEA/H/C/893/A-20/15 (2011)10109 of 22/12/2011
29/12/2011 Referral EMEA/H/C/893/A-20/15 (2011)10110 of 22/12/2011
19/09/2012 Centralised - Renewal EMEA/H/C/893/R/20 (2012)6531 of 17/09/2012
20/12/2012 Centralised - Variation EMEA/H/C/893/WS/324 (2012)9874 of 18/12/2012
01/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/893/T/26 (2013)2649 of 29/04/2013
15/11/2013 Centralised - Modification EMEA/H/C/893/PSUV/29 (2013)8076 of 13/11/2013