Repaglinide Teva

What is Repaglinide Teva?

Repaglinide Teva is a medicine that contains the active substance repaglinide. It is available as round tablets (blue: 0.5 mg; yellow: 1 mg; peach: 2 mg).

Repaglinide Teva is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called NovoNorm. For more information on generic medicines, see the questions and answers by clicking here.

What is Repaglinide Teva used for?

Repaglinide Teva is used in patients with type 2 diabetes (non-insulin-dependent diabetes). It is used in combination with food diets and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) can no longer be controlled through diet, weight loss and exercise. Repaglinide Teva can also be used in combination with metformin (another antidiabetic) in type 2 diabetics whose blood glucose levels are not satisfactorily controlled on metformin alone.

How is Repaglinide Teva used?

Repaglinide Teva should be taken before meals, normally up to 15 minutes before each meal. The dose should be adjusted to obtain the best possible control. The treating physician should regularly measure the patient's blood glucose level to find the lowest effective dose. Repaglinide Teva may also be indicated for type 2 diabetics who are usually well controlled through a diet, but temporarily no longer able to regulate blood glucose.

The recommended starting dose is 0.5 mg. This dose could be increased after one or two weeks. If patients switch to Repaglinide Teva while they are already using another antidiabetic, the recommended starting dose is 1 mg.

How does Repaglinide Teva work?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. Repaglinide Teva helps the pancreas to produce more insulin during meals and is used to control type 2 diabetes.

How has Repaglinide Teva been studied?

Because Repaglinide Teva is a generic medicine, studies have been limited to tests to show that the drug is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).

What are the risks and benefits of Repaglinide Teva?

Because Repaglinide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.

Why has Repaglinide Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Repaglinide Teva has been shown to have comparable quality and to be bioequivalent to NovoNorm. It is the opinion of the CHMP that, as in the case of NovoNorm, the benefits outweigh the identified risks. The Committee recommended that Repaglinide Teva be given marketing authorization.

More information on Repaglinide Teva

The European Commission granted a marketing authorization valid throughout the European Union for Repaglinide Teva to Teva Pharma BV on 29 June 2009.

The full EPAR for Repaglinide Teva can be found here.

The full EPAR of the reference medicine is also found on the Agency's website.

Last update of this summary: 06-2009.

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