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Teva drug receives positive European opinion
Teva’s Ribavirin Teva has received positive opinion from the European Medicines Agency.
Used to treat hepatitis C, the product is a generic version of Schering Plough’s Rebetol therapy, which is already authorised for patient use in the European Union.
The endorsement follows submission by the company in May 2008.
Last year, Teva announced its biosimilar G-CSF product had received marketing authorisation from the European Commission’s Directorate General for Enterprise and Industry.
Used in the treatment of chemotherapy-induced neutropenia, it will be marketed under the name TevaGrastim.
Commenting on the endorsement, president and chief executive officer of European operations Gerard van Odijk said the organisation “drew on its extensive resources to develop this product, receive approval and bring it to the market.
“Our accomplishment ? demonstrates the strength of Teva’s biotechnology R&D capabilities.”
The company added it would begin marketing the product throughout the continent over 2009.
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