Repaglinide Teva

What is Repaglinide Teva?

Repaglinide Teva is a medicine that contains the active substance repaglinide. It is available in the form of 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, please 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 diet 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 with metformin alone.

How is Repaglinide Teva used?

Repaglinide Teva is taken before meals, normally up to 15 minutes before each meal. The dose should be adjusted to achieve 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 used for type 2 diabetics who are usually well controlled through a diet but are temporarily unable to regulate their blood glucose.
The recommended starting dose is 0.5 mg. This dose may 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 make 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?

Since Repaglinide Teva is a generic medicine, the studies have been limited to evidence to show that the medicine 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 associated with Repaglinide Teva?

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

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 CHMP's view that, as in the case of NovoNorm, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Repaglinide Teva.

Other information about Repaglinide Teva

On 29 June 2009, the European Commission released Teva Pharma B.V. a "marketing authorization" for Repaglinide Teva, valid throughout the European Union.
The full version of the EPAR for Repaglinide Teva can be found here.
The full EPAR version of the reference medicine can also be found on the Agency's website.

Last update of this summary: 06-2009.

The information on Repaglinide Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.

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