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Author: Teva Pharma B.V.


Long information

What is it?

Ribavirin Teva is a medicine that contains the active substance ribavirin. It is available as white capsules (200 mg).
Ribavirin Teva is a ?generic medicine?. This means that it is similar to a ?reference medicine? already authorised in the European Union (EU) called Rebetol. For more information on generic medicines, see the question-and-answer document here.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Ribavirin Teva is used to treat patients aged three years and older who have chronic (long-term) hepatitis C (a disease of the liver due to an infection with the hepatitis C virus). Ribavirin Teva must never be used on its own but only together with interferon alfa-2b (another medicine used in hepatitis). Ribavirin Teva can be used in ?naïve? patients (who have not been treated before) for all types of hepatitis C except for genotype 1. It can also be used in adults who previously responded to treatment with interferon alfa but whose disease has come back.
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Ribavirin Teva should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
The dose of Ribavirin Teva is based on the patient?s body weight, and ranges from three to seven capsules a day. It should only be taken by patients weighing at least 47 kg. Ribavirin Teva is taken with food each day in two divided doses (morning and evening). The duration of treatment depends on the patient?s condition and response to treatment, and ranges from 24 weeks to a year. The dose may need to be adjusted for patients who experience side effects. For more information, see the Package Leaflet.

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How does it work?

The active substance in Ribavirin Teva, ribavirin, is an antiviral belonging to the class ?nucleoside analogues?. Ribavirin Teva is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply. Ribavirin Teva on its own has no effect on eliminating the hepatitis C virus from the body.

How has it been studied?

Because Ribavirin Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Ribavirin Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Ribavirin Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva has been shown to have comparable quality and to be bioequivalent to Rebetol. Therefore, the CHMP?s view was that, as for Rebetol, the benefit outweighs the identified risk. The Committee recommended that Ribavirin Teva be given marketing authorisation.

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