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MHLW Requests Label Changes For Three Drugs

This article was originally published in PharmAsia News

Executive Summary

The Food and Drug Safety Department of Japan's Ministry of Health, Labor and Welfare has requested label changes related to warnings for three drugs: BI-Sifrol (pramipexole), a dopaminergic agent for Parkinson's disease made by Nippon Boehringer Ingelheim, Requip (ropinirole) made by GlaxoSmithKline and Endoxan (cyclophosphamide) oral tablet and injection by Shionogi Pharmaceuticals. For Requip and BI-Sifrol, MHLW advised adding warnings related to sudden sleepiness and drowsiness. For Endoxan, the ministry asked for warnings related to liver function disorder, jaundice and acute kidney failure (Click for more-Japanese language

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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