Enforcement record

Administrative Guidance disclosure naming 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)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure24 October 2014

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

24 October 2014

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Apr 30, 2026, 09:02 AM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: 武田薬品工業株式会社Japanese only
Original: 武田薬品工業株式会社
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: 24 October 2014
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-30T00:01:36.149+00:00
Evidence checked: 2026-04-30T00:01:36.149+00:00
Archive captured: 2026-04-30T00:02:08.973353+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": null,
    "corporate_number": null,
    "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": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (武田薬品工業株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "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",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/02af10b2bekpy7ze",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000062032.html",
    "archiveCapturedAt": "2026-04-30T00:02:08.973353+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": "2026-10-11T02:15:09.082Z"
  },
  "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)

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