What is Ribavirin Three Rivers?
Ribavirin Three Rivers is a medicine that contains the active substance ribavirin. It is available in white capsules (200 mg).
Ribavirin Three Rivers is a "generic medicine", which means that Ribavirin Three Rivers is similar to a "reference medicine" already authorized in the European Union (EU) called Rebetol.
What is Ribavirin Three Rivers used for?
Ribavirin Three Rivers is indicated for the treatment of patients from 3 years of age with long-term hepatitis C (a liver disease due to infection with the hepatitis C virus). Ribavirin Three Rivers should never be used on its own (monotherapy), but only in combination with an interferon alfa-2b (another type of medicine used to treat hepatitis).
Ribavirin Three Rivers is used in patients who have not been treated before, as long as the liver is still functioning and the blood contains the hepatitis C virus. Ribavirin Three Rivers can also be used in adults who have relapsed after a previous treatment or whose previous treatment did not has given an answer.
The medicine can only be obtained with a prescription.
How is Ribavirin Three Rivers used?
Three Rivers Ribavirin therapy should be started and monitored by physicians experienced in the management of long-term hepatitis C. The dosage of Ribavirin Three Rivers depends on the patient's body weight and varies from three to seven capsules a day. Ribavirin Three Rivers can only be taken by patients weighing more than 47 kg. It must be taken every day with meals, in two divided doses (morning and evening). The duration of treatment depends on the patient's condition and his response to therapy and varies from six months 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 Three Rivers work?
The active substance of Ribavirin Three Rivers, ribavirin, is an antiviral that belongs to the class of "nucleoside analogues". Three Rivers Ribavirin was designed to interfere with the production or action of viral DNA and RNA, necessary for viruses to survive and multiply. Ribavirin Three Rivers in monotherapy is ineffective in eliminating the hepatitis C virus from the body.
How has Ribavirin Three Rivers been studied?
Because Ribavirin Three Rivers is a generic medicine, studies in patients have been limited to tests to show that it is bioequivalent to the reference medicine, Rebetol. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Olanzapine Ribavirin Three Rivers?
Because Ribavirin Three Rivers is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Why has Ribavirin Three Rivers been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ribavirin Three Rivers 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 benefit outweighs the identified risk. The committee recommended the granting of marketing authorization for Ribavirin Three Rivers.
More information on Ribavirin Three Rivers
On 10 June 2010, the European Commission granted Three Rivers Global Pharma Limited a marketing authorization for Ribavirin Three Rivers, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Ribavirin Three Rivers can be found here. For more information on treatment with Ribavirin Three Rivers, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 04-2010.
