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Cotronak (ribavirin)

Region
🇪🇺 EU
Active substance
ribavirin
Company
Schering-Plough Europe
Status
Withdrawn
Therapeutic area
Hepatitis C, Chronic
EU approval
Fri 07 May 1999
Application
EMEA/H/C/000247
ATC
J05AB04
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.