The health ministry will censure a Japanese unit of Swiss pharmaceutical giant Novartis AG for failing to report serious side effects from some of its drugs within a certain period of time, sources close to the matter said Wednesday.
The Ministry of Health, Labor and Welfare will serve Tokyo-based Novartis Pharma K.K. with a business improvement order, possibly as early as this month.
The case centers on side effects observed in around 5,500 patients, which should have been reported to the state within a few weeks of discovery.
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