PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Ribavirin BioPartners?
Ribavirin BioPartners is a medicine that contains the active substance ribavirin. It is available as white round tablets (200 mg).
Ribavirin BioPartners is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Rebetol.
What is Ribavirin BioPartners used for?
Ribavirin BioPartners 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 BioPartners should never be used alone, but only in combination with peginterferon alfa-2b or interferon alfa-2b (other drugs used in the treatment of hepatitis).
Ribavirin BioPartners 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. This includes adults (18 years and over) who are also suffering from the human immunodeficiency virus ( HIV). Ribavirin BioPartners can also be used in adults who have relapsed after previous treatment or whose previous treatment has not been answered.
The medicine can only be obtained with a prescription.
How is Ribavirin BioPartners used?
Ribavirin BioPartners therapy should be started and monitored by physicians experienced in the treatment of long-term hepatitis C. The dosage of Ribavirin BioPartners depends on the patient's body weight and varies from three to seven capsules a day. Ribavirin BioPartners 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 condition of the patient and his response to treatment and can vary from six weeks to one year. In case of side effects it may be necessary to adjust the dosage. For more information, see the package leaflet.
How does Ribavirin BioPartners work?
The active substance in Ribavirin BioPartners, ribavirin, is an antiviral medicine that belongs to the class of "nucleoside analogues". Ribavirin BioPartners has been designed to interfere with the production or action of viral DNA and RNA, necessary for viruses to survive and multiply. Ribavirin BioPartners as monotherapy is ineffective in eliminating the hepatitis C virus from the body.
How has Ribavirin BioPartners been studied?
Because Ribavirin BioPartners 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 Ribavirin BioPartners?
Because Ribavirin BioPartners is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine.
Why has Ribavirin BioPartners been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ribavirin BioPartners 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 the release of the marketing authorization for Ribavirin BioPartners.
More information on Ribavirin BioPartners
On 6 April 2010, the European Commission granted a marketing authorization valid for throughout the European Union to BioPartners GmbH for Ribavirin BioPartners.
The full EPAR for Ribavirin BioPartners can be found here. For more information on treatment with Ribavirin BioPartners, read the package leaflet (also part of the EPAR).
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 02-2010.
