About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Ribavirin Teva Pharma B.V.?
Ribavirin Teva Pharma B.V. is a medicine that contains the active substance ribavirin. It is available as pink tablets (200 and 400 mg).
Ribavirin Teva Pharma B.V. is a ‘generic medicine’. This means that Ribavirin Teva Pharma B.V. is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Rebetol.
- What is Ribavirin Teva Pharma B.V. used for?
Ribavirin Teva Pharma B.V. 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 Teva Pharma B.V. must never be used on its own but only together with interferon alfa-2b (another medicine used in hepatitis).
Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood. Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
The medicine can only be obtained with a prescription.
- How is Ribavirin Teva Pharma B.V. used?
Treatment with Ribavirin Teva Pharma B.V. should be started and monitored by a doctor who has experience in the management of chronic hepatitis C
The dose of Ribavirin Teva Pharma B.V. is based on the patient’s body weight, and ranges from 600 to 1,400 mg a day. It should only be taken by patients weighing at least 47 kg. Ribavirin Teva Pharma B.V. 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 Teva Pharma B.V. work?
The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues’. Ribavirin Teva Pharma B.V. is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply. Ribavirin Teva Pharma B.V. on its own has no effect on eliminating the hepatitis C virus from the body.
- How has Ribavirin Teva Pharma B.V. been studied?
Because Ribavirin Teva Pharma B.V. is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine. 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 Teva Pharma B.V.?
Because Ribavirin Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
- Why has Ribavirin Teva Pharma B.V. been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. 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 Teva Pharma B.V. be given marketing authorisation.
- Other information about Ribavirin Teva Pharma BV
The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. to Teva Pharma B.V. on 1 July 2009. The marketing authorisation is valid for five years, after which it can be renewed.
This EPAR was last updated on 01/04/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
21/02/2011 Ribavirin Teva Pharma B.V. -EMEA/H/C/001064 -WS/0081
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3-years of age or older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. 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).
Naïve patients
Adult patients: Ribavirin Teva Pharma B.V. 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 hepatitis C viral ribonucleic acid HCV-RNA.
Children 3 years of age and older and adolescents: Ribavirin Teva Pharma B.V. is intended for use, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 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 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.
Previous treatment failure patients
Adult patients: Ribavirin Teva Pharma B.V. 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.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Ribavirin Teva Pharma B.V. : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 22/01/2010 | 01/04/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Ribavirin Teva Pharma B.V. : EPAR - Public assessment report | (English only) | 27/07/2009 |
Authorised
This medicine is approved for use in the European Union
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