Administrative Guidance against ヤンセンファーマ株式会社
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/api/v1/enforcements?corporate_number=4010001089128&limit=10Action summary
- Company
- ヤンセンファーマ株式会社Japanese originalOriginal: ヤンセンファーマ株式会社Corporate Number: 4010001089128
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched by normalized Japanese company name to an enriched company profile with a Corporate Number.
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- 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
Show original Japanese text
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こと
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 医薬品医療機器等法.
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
- 2026-05-06T00:02:11.855+00:00
- Evidence checked
- 2026-05-06T00:02:11.855+00:00
- Archive captured
- 2026-05-06T00:02:12.905+00:00
Show audit JSON
{
"record": {
"id": "8dae1131-9c00-4b6a-939e-0083e6b911a7",
"url": "https://regbase.jp/en/enforcement/other-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": "医薬品医療機器等法",
"en": "医薬品医療機器等法"
},
"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": "Japanese regulatory disclosure under 医薬品医療機器等法."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-yansenhuama-20140417",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
"archiveUrl": "https://kiroku.today/view/2bab1a77aftam3jo",
"archiveCapturedAt": "2026-05-06T00:02:12.905+00:00",
"extractedAt": "2026-05-06T00:02:11.855+00:00",
"translatedAt": null,
"evidenceCheckedAt": "2026-05-06T00:02:11.855+00:00",
"generatedAt": "2026-05-20T22:29:43.027Z"
},
"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
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.