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Gazette Premium Content EU regulator: No more problems with Roche drugs

Associated Press Updated: November 19, 2013 at 7:46 am
Associated Press Updated: November 19, 2013 at 7:46 am • Published: November 19, 2013

LONDON (AP) — The European Medicines Agency says it has finished an investigation of the way pharmaceutical giant Roche reported side effects for 19 drugs in the U.S. and has found no new safety concerns. Last year, the agency took action against Roche after alleging the Swiss drug maker failed...

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LONDON (AP) — The European Medicines Agency says it has finished an investigation of the way pharmaceutical giant Roche reported side effects for 19 drugs in the U.S. and has found no new safety concerns.

Last year, the agency took action against Roche after alleging the Swiss drug maker failed to properly report side effects for the medicines, including the cancer drugs Avastin, Herceptin and Xeloda. British authorities said there were "serious shortcomings" in how Roche AG reported potential problems.

In a statement Tuesday, the European regulator said further safety data on the medicines showed "the balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use." It said Roche continued to provide additional information as part of their obligatory follow-up.

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