Administrative Guidance against ヤンセンファーマ株式会社

ヤンセンファーマ株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareConfirmed entity match17 April 2014

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/api/v1/enforcements?corporate_number=4010001089128&limit=10

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Action summary

Company: ヤンセンファーマ株式会社Japanese original
Original: ヤンセンファーマ株式会社
Corporate Number: 4010001089128
Entity match: Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
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

Violation

Machine-translated summary — verify against original

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-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-25T00:05:06.978+00:00
Evidence checked: 2026-04-25T00:05:06.978+00:00
Archive captured: 2026-04-04T12:00:40.383+00:00

Show audit JSON

{
  "record": {
    "id": "9bef1505-c5ab-4a38-b2db-005c17c2643d",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yansenhuama-20140417",
    "company_name_original": "ヤンセンファーマ株式会社",
    "company_name_registry": "ヤンセンファーマ株式会社",
    "corporate_number": "4010001089128",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "行政指導",
      "en": "Administrative Guidance"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-yansenhuama-20140417",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
    "archiveUrl": "https://kiroku.today/view/2bab1a77afka6sfy",
    "archiveCapturedAt": "2026-04-04T12:00:40.383+00:00",
    "extractedAt": "2026-04-25T00:05:06.978+00:00",
    "translatedAt": "2026-05-01T06:55:22.177+00:00",
    "evidenceCheckedAt": "2026-04-25T00:05:06.978+00:00",
    "generatedAt": "2026-05-20T22:31:44.112Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Language

日本語版を見る (Japanese)

Company info

English name: ヤンセンファーマ株式会社 Japanese original
Japanese name: ヤンセンファーマ株式会社
Corporate Number: 4010001089128
Registered address: 東京都千代田区西神田３丁目５番２号

See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.