Ribavirin Teva Pharma B.V.

ribavirin

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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 its 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.

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 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.

Name Language First published Last updated
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public BG = bălgarski 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public ES = español 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public CS = čeština 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public DA = dansk 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public DE = Deutsch 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public ET = eesti keel 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public EL = elliniká 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public EN = English 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public FR = français 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public IT = italiano 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public LV = latviešu valoda 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public LT = lietuvių kalba 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public HU = magyar 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public MT = Malti 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public NL = Nederlands 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public PL = polski 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public PT = português 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public RO = română 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public SK = slovenčina 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public SL = slovenščina 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public FI = suomi 19/10/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - Summary for the public SV = svenska 19/10/2009 26/07/2013

This EPAR was last updated on 14/04/2014 .

Authorisation details

Product details

Product details for Ribavirin Teva Pharma B.V.
NameRibavirin Teva Pharma B.V.
Agency product numberEMEA/H/C/001064
Active substance

ribavirin

International non-proprietary name (INN) or common name

ribavirin

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AB04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Ribavirin Teva Pharma B.V.
Marketing-authorisation holder

Teva Pharma B.V.

Revision9
Date of issue of marketing authorisation valid throughout the European Union01/07/2009

Contact address:

Teva Pharma B.V.
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

Product information

11/03/2014  Ribavirin Teva Pharma B.V. -EMEA/H/C/001064 -IB/0014

Name Language First published Last updated
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014
Ribavirin Teva Pharma B.V. : EPAR - Product Information SV = svenska 19/10/2009 14/04/2014

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.


Name Language First published Last updated
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013
Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations SV = svenska 08/07/2009 26/07/2013

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 three 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 HCV ribonucleic acid (HCV-RNA).

Paediatric patients (children three years of age and older and adolescents)

Ribavirin Teva Pharma B.V. 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 HCV-RNA.

When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition, that may be irreversible in some patients.

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

Initial marketing-authorisation documents

Authorised

This medicine is approved for use in the European Union

More information on Ribavirin Teva Pharma B.V.