Enforcement record
Administrative Guidance disclosure naming ヤンセンファーマ株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
17 April 2014
Current page: Enforcement record
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Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
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- Not confirmed; shown under the published name
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- Queued for preservation
- Captured: Jul 12, 2026, 03:50 PM JST
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Action summary
- Company
- ヤンセンファーマ株式会社Japanese onlyOriginal: ヤンセンファーマ株式会社
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- 17 April 2014
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品
Violation
The Ministry of Health, Labour and Welfare has instructed the manufacturer (Janssen Pharmaceutical K.K.) to revise the 'Precautions for Use' in the package insert and to promptly notify healthcare professionals via a safety bulletin (Blue Letter), based on reports of multiple deaths among patients using the schizophrenia treatment drug Zeprion Water Suspension, even though the causal relationship is unknown.
Show original Japanese text
製造販売業者に対し、添付文書の「使用上の注意」の改訂と、「安全性速報（ブルーレター）」により医療関係者等に注意喚起を行うよう指示
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
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Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.