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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/11/721|
|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 in the treatment of type 2 diabetes mellitus:|
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:||Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|22/03/2012||Centralised - Authorisation - Decision addressed to Member States||EMEA/H/C/2309||(2012)2032 of 21/03/2012|
|26/03/2012||Centralised - Authorisation||EMEA/H/C/2309||(2012)2031 of 21/03/2012|
|14/11/2013||Centralised - Variation||EMEA/H/C/2309/IB/1|
|15/01/2014||Centralised - Variation||EMEA/H/C/2309/IB/2|