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 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match17 April 2014
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/api/v1/enforcements?corporate_number=4010001089128&limit=10

Action summary

Company
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
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-medium

Administrative 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

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

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.