On 24 May 2022 the European Commission withdrew the marketing authorisation for Glubrava (pioglitazone / metformin hydrochloride) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Glubrava was granted marketing authorisation in the EU on 11 December 2007 for treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5\-year period. It was subsequently renewed for an additional 5\-year period in 2012\. It was then granted unlimited validity in 2017\. The product had not been marketed in the EU since 2021\. Glubrava is identical to Competact, which is authorised in the EU to treat type 2 diabetes mellitus in adult patients. The European Public Assessment Report (EPAR) for Glubrava is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
A10BD05
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
EMA Name
Glubrava
Medicine Name
Glubrava
Aliases
N/ANo risk management plan link.
