Ribavirin Teva - ribavirin

PLEASE NOTE: THE USE OF THIS MEDICINAL PRODUCT IS CURRENTLY SUSPENDED IN THE EUROPEAN UNION

What is Ribavirin Teva?

Ribavirin Teva is a medicine that contains the active substance ribavirin. The medicine is presented in white capsules (200 mg).

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

What is Ribavirin Teva used for?

Ribavirin Teva is indicated for the treatment of patients aged 3 years or older with hepatitis C (a liver infection caused by the hepatitis C virus) of chronic type (protracted). Ribavirin Teva should never be used on its own (monotherapy), but only in combination with an interferon alfa 2-b (another type of drug used to treat hepatitis).

Ribavirin Teva can be used in patients "naïf" to treatment (ie never treated previously) for all types of hepatitis C except for genotype 1. It can also be used in adults who have previously responded to treatment with alpha interferon, but where the disease has remained.

The medicine can only be obtained with a prescription.

How is Ribavirin Teva used?

Ribavirin Teva therapy should be started and monitored by physicians experienced in the treatment of chronic hepatitis C. The dosage of Ribavirin Teva depends on the patient's body weight and ranges from three to seven capsules a day. Ribavirin Teva should only be taken by patients weighing at least 47 kg. It must be taken every day with meals, in two divided doses (morning and evening). The duration of treatment depends on the condition of the patient and his response to treatment and can vary from 24 weeks to a year. In case of side effects it may be necessary to adjust the dosage. For more information, see the package leaflet.

How does Ribavirin Teva work?

The active substance in Ribavirin Teva, ribavirin, is an antiviral medicine that belongs to the class of "nucleoside analogues". Ribavirin Teva was designed to interfere with the production or action of viral DNA and RNA, necessary for viruses to survive and multiply. Ribavirin Teva in monotherapy is ineffective in eliminating the hepatitis C virus from the body.

How has Ribavirin Teva been studied?

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

What are the benefits and risks of Ribavirin Teva?

Because Ribavirin 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 Ribavirin Teva been approved?

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