Enforcement record
Administrative Guidance disclosure naming 武田薬品工業株式会社
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
24 October 2014
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-YAKKIHO-WU-TIAN-Y-202608191751
- Generated at
- 20 August 2026 at 02:51
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20141024
1. Review Summary
| Disclosure name | 武田薬品工業株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 24 October 2014 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | Administrative Guidance |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | 武田薬品工業株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | 武田薬品工業株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / Administrative Guidance |
| Action / announcement date | Action: 24 October 2014 / Announcement: 30 April 2026 |
| English summary | 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. |
| 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。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000062032.html |
| Source archive | https://kiroku.today/a/02af10b2bekpy7ze |
| Extraction / evidence timestamps | Extracted: 30 April 2026 at 09:01 / Evidence checked: 30 April 2026 at 09:01 / Archive captured: 30 April 2026 at 09:02 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
Save the disclosure record naming 武田薬品工業株式会社
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Preserved evidence by Kiroku
Review the preserved source for 武田薬品工業株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
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Action summary
- Company
- 武田薬品工業株式会社Japanese onlyOriginal: 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
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-mediumAdministrative 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
- 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": "2026-08-19T17:51:32.689Z"
},
"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.