European Commission suspended the license of Roche Antiretroviral Viracept in the market
The European Commission on Tuesday suspended the license Roches Swiss pharmaceutical company to market its antiretroviral drug Viracept because of contamination with the substance ethyl mesilate in certain lots of drugs, Reuters reports (Reuters, 8 / 7). According to the AP / International Herald Tribune, ethyl mesilate can damage DNA and cause cancer (AP / International Herald Tribune, 08/07). BRBRThe European Medicines Agency in June recalled Viracept because of contamination. Roche said in a statement recalling all batches of drugs in Europe and other countries in a unique collaboration with EMA and Swissmedic, switzerlands drug regulator.According to Roche, the drug has been recalled after tests showed some batches were contaminated with higher than normal levels of methane
sulfonic acid ethyl ester - a chemical commonly used in medication in small burns quantities.BRBRWilliam CEO Roche Pharmaceuticals Division, said the contamination was caused by the interaction of two chemicals in a container that produces the drug. Roche also announced that it plans to establish patient registries to monitor the health of HIV-positive people taking the drug (Kaiser Daily HIV / AIDS, 7 / 24).BRBRAccording of the European Commission, the suspension was based on scientific data from EMA and consultations with members of the European Union. Roche expects to market Viracept, which is commonly known as nelfinavir, has reviewed the European Union beginning in September or October, according to new data security EMA, according to a spokesman (Reuters, 07:08). Roche
spokeswoman Claudia Schmitt said the company needs to be validated in an intense debate with the EMA to the new manufacturing process for Viracept.Roche is not expected that the suspension of the Companys financial perspective affects this year, reports the AP / Tribune (AP / International Herald Tribune, 07.08).Reprinted with permission from Kaiser Network. You can change the entire Kaiser Daily Health Policy Report, click to visit
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