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The marketing authorisation for Cotronak has been withdrawn at the request of the marketing authorisation holder.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