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Ribavirin Mylan

Previous name: Ribavirin Three Rivers
Active Substance: ribavirin
Common Name: ribavirin
ATC Code: J05AB04
Marketing Authorisation Holder: Generics [UK] Ltd
Active Substance: ribavirin
Status: Authorised
Authorisation Date: 2010-06-10
Therapeutic Area: Hepatitis C, Chronic
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents).  Ribavirin monotherapy must not be used.

There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).

Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.

Naïve patients

Adult patients

Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum hepatitis-C-virus (HCV) RNA.

Children and adolescents

Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV RNA.  When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).

Previously treatment-failure patients

Adult patients

Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.  

What is Ribavirin Mylan?

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. 

What is Ribavirin Mylan used for?

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.

How is Ribavirin Mylan used?

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.

How does Ribavirin Mylan work?

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.

How has Ribavirin Mylan been studied?

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.

What are the benefit and risk of Ribavirin Mylan?

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.

Why has Ribavirin Mylan been approved?

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.

Other information about Ribavirin Mylan

The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Three Rivers on 10 June 2010. The name of the medicine was changed to Ribavirin Mylan on 27 January 2011. The marketing authorisation is valid for five years, after which it can be renewed. The marketing-authorisation holder is Generics [UK] Ltd.

For more information about treatment with Ribavirin Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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