Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pioglitazone Actavis   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Pioglitazon Actavis (CS)
   - Pioglitazon Actavis (DA)
   - Pioglitazon Actavis (DE)
   - Pioglitazona Actavis (ES)
   - Pioglitazona Actavis (PT)
   - Pioglitazonă Actavis (RO)
   - Pioglitazon Actavis (SL)
Auth. number : EU/1/12/755
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.
  • 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: Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

  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
19/03/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2324 (2012)1853 of 15/03/2012
20/03/2012 Centralised - Authorisation EMEA/H/C/2324 (2012)1852 of 15/03/2012
08/11/2013 Centralised - Variation EMEA/H/C/2324/IB/1
12/12/2013 Centralised - Variation EMEA/H/C/2324/IB/2