Author: BioPartners GmbH


Long information

What is it?

Ribavirin BioPartners is a medicine that contains the active substance ribavirin. It is available as round, white tablets (200 mg).

Ribavirin BioPartners is a ?generic medicine?. This means that Ribavirin BioPartners 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.

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 BioPartners is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older. Ribavirin BioPartners must never be used on its own but only together with peginterferon alfa 2b or interferon alfa 2b (other medicines used in hepatitis).

Ribavirin BioPartners is used in patients who have not been treated before, as long as the liver is still working and hepatitis C virus can be found in the blood. This includes adults (aged 18 years and older) who are also infected with human immunodeficiency virus (HIV). Ribavirin BioPartners can also be used in adults whose disease has come back after previous treatment or whose previous treatment failed.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Ribavirin BioPartners should be started and monitored by a doctor who has experience in the management of long-term hepatitis C. The dose of Ribavirin BioPartners is based on the patient?s body weight, and ranges from three to seven tablets a day. It can only be used in patients who weigh more than 47 kg. Ribavirin BioPartners 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 six months to a year. The dose may need to be adjusted for patients who experience side effects. For more information, see the Package Leaflet.

How does it work?

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

How has it been studied?

Because Ribavirin BioPartners is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Rebetol. 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 BioPartners 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.

What is the risk associated?

Because Ribavirin BioPartners 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 it been approved?

The CHMP concluded that, in accordance with EU requirements, Ribavirin BioPartners 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 BioPartners be given marketing authorisation.

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