REGULATORY
MHLW Orders Label Revisions for Mitsubishi Tanabe’s Zione; “Anaphylaxis” to Be Added to Adverse Reactions
The Ministry of Health, Labor and Welfare (MHLW) ordered on November 27 a revision to package inserts of Mitsubishi Tanabe Pharma’s hemorrhoid treatment Zione Injection (aluminum potassium sulfate + tannic acid) to add “anaphylaxis” to the clinically significant adverse drug…
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