Ribavirin Teva Pharma B.V.

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ribavirin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ribavirin Teva Pharma B.V.

For practical information about using Ribavirin Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/03/2021

Authorisation details

Product details
Name
Ribavirin Teva Pharma B.V.
Agency product number
EMEA/H/C/001064
Active substance
Ribavirin
International non-proprietary name (INN) or common name
ribavirin
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AP01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
01/07/2009
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

18/02/2021 Ribavirin Teva Pharma B.V. - EMEA/H/C/001064 - IA/0023

Contents

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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 in combination with other medicinal products for the treatment of

chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).

Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of

chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not

previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).

Assessment history

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