Cotronak
Withdrawn
This medicine's authorisation has been withdrawn
ribavirin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Cotronak has been withdrawn at the request of the marketing authorisation holder.
Product information
01/03/2004
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Cotronak
- Active substance
- ribavirin
- International non-proprietary name (INN) or common name
- ribavirin
- Therapeutic area (MeSH)
- Hepatitis C, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AB04
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic 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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