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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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|
|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:|
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
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.
|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|