Ribavirin Mylan 200 mg hard capsules

Ribavirin Mylan is a medicine that contains the active substance ribavirin. It is available as white capsules (200 mg).

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

Ribavirin Mylan 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 Mylan must never be used on its own but only together with interferon alfa-2b (another medicine used in hepatitis).

Ribavirin Mylan 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. Ribavirin Mylan 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.

1 Previously known as Ribavirin Three Rivers

Treatment with Ribavirin Mylan should be started and monitored by a doctor who has experience in the management of long-term hepatitis C. The dose of Ribavirin Mylan is based on the patient?s body weight, and ranges from three to seven capsules a day. It can only be used in patients who weigh more than 47 kg. Ribavirin Mylan 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.

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

Because Ribavirin Mylan 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.

Because Ribavirin Mylan 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.

Because Ribavirin Mylan 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.

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