Copegus 400mg OKed in Holland, MRP begun

Switzerland-based drug major Roche says that, following the Dutch Medicines Evaluation Board's approval of its hepatitis C drug Copegus (ribavirin) at 400mg dosage, a European Union Mutual Recognition Procedure has been initiated. This is a key step towards making the formulation available across the continent says the firm.

The drug, which is manufactured in film-coated 200mg and 400mg tablet form, is indicated for the treatment of chronic hepatitis B infection in combination with the firm's Pegasys (peginterferon alfa-2a) product. The group adds that the drug is available to a broad range of patients, including those with cirrhotic or inflamed liver, as-well-as people who are co-infected with HIV.

William Burns, head of Roche's pharmaceutical division said that the new formulation would help patients adhere to treatment and provide them with the best chance of a cure. The company added that it expects to receive EU-wide approval for use of the product in the next three months.