Ribavirin Teva Pharma B.V.
European Medicines Agency
Doc. Ref.: EMA/640600/2009 EMEA/H/C/1064
Ribavirin Teva Pharma B.V.
ribavirin
EPAR summary for the public
This document 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 for 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. For more information on generic medicines, see the question-and-answer document here.
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
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.
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 B.V.:
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.
The full EPAR for Ribavirin Teva Pharma B.V. can be found here.
The full EPAR for the reference medicine can also be found on the Agency’s website.
This summary was last updated in 10-2009.
2/2