Cotronak

RSS

ribavirin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Cotronak has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 01/03/2004

Authorisation details

Product details
Name
Cotronak
Agency product number
EMEA/H/C/000247
Active substance
Ribavirin
International non-proprietary name (INN) or common name
ribavirin
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AB04
Publication details
Marketing-authorisation holder
Schering-Plough Europe
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
07/05/1999
Contact address
SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium

Product information

01/03/2004 Cotronak - EMEA/H/C/000247 -

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

Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.
There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.

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