Pioglitazone ratiopharm GmbH: Withdrawal of the marketing authorisation application

Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone. It was to be available as tablets (15, 30 and 45 mg).

Pioglitazone ratiopharm GmbH was developed as a 'generic medicine'. This means that Pioglitazone ratiopharm GmbH is similar to a 'reference medicine' already authorised in the European Union (EU) called Actos.

Pioglitazone ratiopharm GmbH was to be used to treat type 2 diabetes in adults, particularly those who are overweight. It was to be used in addition to diet and exercise.

Pioglitazone ratiopharm GmbH was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone ratiopharm GmbH was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.

Pioglitazone ratiopharm GmbH was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

The evaluation had finished and the CHMP had given a positive opinion. The company withdrew before the European Commission had issued a decision on this opinion.

The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos. Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm GmbH for the treatment of type 2 diabetes.

The withdrawal letter is available under the 'All documents' tab.