Ribavirin Teva Pharma B.V.

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ribavirin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ribavirin Teva Pharma B. V. has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 09/07/2021

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

22/06/2021 Ribavirin Teva Pharma B.V. - EMEA/H/C/001064 - IA/0023

Contents

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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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