Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACTOS
Active substances:
Pioglitazone
Estonian, English, Latin
ATC code: A10BG03
Dosage form: tablet
Strength: 15mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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 as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination with - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. - 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 (see section 4.4). 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 (see section 4.4).
Safety features: Yes
Marketing authorization holder: Cheplapharm Arzneimittel GmbH 
Marketing authorization number: EU/1/00/150 
Marketing authorization issued on: February 8, 2002 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1013566  ACTOS  tablet  15mg 28TK  Prescription      10.12.2014   
1209372  ACTOS  tablet  15mg 14TK  Prescription         
1209383  ACTOS  tablet  15mg 30TK  Prescription         
1209394  ACTOS  tablet  15mg 50TK  Prescription         
1209406  ACTOS  tablet  15mg 56TK  Prescription         
1209417  ACTOS  tablet  15mg 84TK  Prescription         
1209428  ACTOS  tablet  15mg 90TK  Prescription         
1209439  ACTOS  tablet  15mg 98TK  Prescription         
1494402  ACTOS  tablet  15mg 112TK  Prescription         
1494413  ACTOS  tablet  15mg 196TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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