Administrative Guidance against 塩野義製薬株式会社

塩野義製薬株式会社 (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 match17 January 2014
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/api/v1/enforcements?corporate_number=9120001077430&limit=10

Action summary

Company
Original: 塩野義製薬株式会社
Corporate Number: 9120001077430
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
17 January 2014
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Show original Japanese text

血栓症に関する注意喚起がなされているにもかかわらず、血栓症による国内死亡例が報告されたことを受け、医療関係者向けの情報提供資材を配布し、患者に血栓症の症状を説明し、服用中に症状が出た場合は直ちに服用を中止し救急医療機関を受診するよう指導している。

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
2026-05-05T18:01:53.723+00:00
Evidence checked
2026-05-05T18:01:53.723+00:00
Archive captured
2026-05-05T18:01:54.388+00:00
Show audit JSON
{
  "record": {
    "id": "8d7e8dfe-eace-4c90-9c03-332da09cd743",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yan-ye-yi-zhi-yao-20140117",
    "company_name_original": "塩野義製薬株式会社",
    "company_name_registry": "塩野義製薬株式会社",
    "corporate_number": "9120001077430",
    "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-yan-ye-yi-zhi-yao-20140117",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000034892.html",
    "archiveUrl": "https://kiroku.today/view/b55f068cfesxqquh",
    "archiveCapturedAt": "2026-05-05T18:01:54.388+00:00",
    "extractedAt": "2026-05-05T18:01:53.723+00:00",
    "translatedAt": null,
    "evidenceCheckedAt": "2026-05-05T18:01:53.723+00:00",
    "generatedAt": "2026-05-20T20:14:17.889Z"
  },
  "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
塩野義製薬株式会社 Japanese original
Japanese name
塩野義製薬株式会社
Corporate Number
9120001077430
Registered address
大阪府大阪市中央区道修町3丁目1番8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.