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The marketing authorisation for Cotronak has been withdrawn at the request of the marketing authorisation holder.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 |
SP Europe
Rue de Stalle, 73 B-1180 Bruxelles Belgium |
Product information
01/03/2004 Cotronak - EMEA/H/C/000247 -
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.