Navigation path

Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pioglitazone Teva Pharma   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Pioglitazon Teva Pharma (DE)
   - Pioglitazona Teva Pharma (ES)
   - Pioglitazon Teva Pharma (NL)
   - Pioglitazona Teva Pharma (PT)
   - Pioglitazon Teva Pharma (SL)
Auth. number : EU/1/12/758
Active substance : 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
  • 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.
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: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
28/03/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2410 (2012)2183 of 26/03/2012
29/03/2012 Centralised - Authorisation EMEA/H/C/2410 (2012)2184 of 26/03/2012
12/04/2013 Centralised - Variation
Updated with Decision(2014)10091 of 16/12/2014
25/11/2013 Centralised - Variation EMEA/H/C/2410/IB/3/G
Updated with Decision(2014)10091 of 16/12/2014
18/12/2014 Centralised - Yearly update (2014)10091 of 16/12/2014
03/02/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2410/T/8 (2015)583 of 30/01/2015