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🇪🇺EU · EMAWithdrawnATC: A10BD05

Glubrava(metformin hydrochloride;pioglitazone hydrochloride)

Diabetes Mellitus, Type 2

Marketing Authorisation Holder: Takeda Pharma A/S

EMA Authorisation: 11/12/2007

INN: pioglitazone;metformin

Indication

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six 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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.