Administrative Guidance against 武田薬品工業株式会社

武田薬品工業株式会社 (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 match24 October 2014

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Action summary

Company: 武田薬品工業株式会社Japanese original
Original: 武田薬品工業株式会社
Corporate Number: 2120001077461
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: 24 October 2014
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

There have been reports of cases where administration of this drug caused a significant increase in blood bilirubin levels, leading to liver and kidney dysfunction, and resulting in death. Therefore, the following precautions should be observed: 1. Regularly measure blood bilirubin levels during treatment. 2. Discontinue the drug and provide appropriate treatment if abnormal persistent elevation of blood bilirubin is observed. 3. Even after discontinuation, blood bilirubin levels may remain elevated; patients should be monitored carefully. 4. Instruct patients to seek medical attention immediately if they develop jaundice of the eyes or skin, dark urine, or general fatigue after administration.

Show original Japanese text

本剤投与により血中ビリルビン値が著しく上昇し、肝機能障害、腎機能障害等を発現し、死亡に至った症例が報告されているので、次の事項に注意すること。1.本剤投与中は定期的に血中ビリルビン値を測定すること。2.血中ビリルビン値の持続的な上昇等の異常が認められた場合には本剤の投与を中止し、適切な処置を行うこと。3.本剤投与中止後も血中ビリルビン値が上昇することがあるので、患者の状態を注意深く観察すること。4.患者に対し、本剤投与後に眼球・皮膚の黄染、褐色尿、全身倦怠感等がみられた場合は、直ちに受診するよう指導すること。

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: 2026-04-30T00:01:36.149+00:00
Evidence checked: 2026-04-30T00:01:36.149+00:00
Archive captured: 2026-04-30T00:01:37.298+00:00

Show audit JSON

{
  "record": {
    "id": "cbcd07a1-16ca-4620-8649-a395533bd354",
    "url": "https://regbase.jp/en/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20141024",
    "company_name_original": "武田薬品工業株式会社",
    "company_name_registry": "武田薬品工業株式会社",
    "corporate_number": "2120001077461",
    "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-wu-tian-yao-pin-gong-ye-20141024",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000062032.html",
    "archiveUrl": "https://kiroku.today/view/02af10b2bekpy7ze",
    "archiveCapturedAt": "2026-04-30T00:01:37.298+00:00",
    "extractedAt": "2026-04-30T00:01:36.149+00:00",
    "translatedAt": "2026-05-01T09:46:27.501+00:00",
    "evidenceCheckedAt": "2026-04-30T00:01:36.149+00:00",
    "generatedAt": "2026-06-19T11:01:55.058Z"
  },
  "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: 武田薬品工業株式会社 Japanese original
Japanese name: 武田薬品工業株式会社
Corporate Number: 2120001077461
Registered address: 大阪府大阪市中央区道修町４丁目１番１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.