Criminal Accusation against ノバルティス　ファーマ株式会社

ノバルティス　ファーマ株式会社 (薬事法)

薬事法Ministry of Health, Labour and WelfareConfirmed entity match9 January 2014

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/api/v1/enforcements?corporate_number=4010401011491&limit=10

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Action summary

Company: ノバルティス　ファーマ株式会社Japanese original
Original: ノバルティス　ファーマ株式会社
Corporate Number: 4010401011491
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: 薬事法
薬事法
Action type: Criminal Accusation
告発
Action date: 9 January 2014
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Novartis Pharma K.K. used materials that described the results of clinical studies, the 'JIKEI HEART Study' conducted at Tokyo Jikei Medical University and the 'KYOTO HEART Study' conducted at Kyoto Prefectural University of Medicine, to advertise the efficacy or effects of the drug Diovan tablets. These advertisements were made using the results of these clinical studies.

Show original Japanese text

ノバルティス　ファーマ株式会社は、平成23年から平成24年にかけて、ディオバン錠に係る東京慈恵会医科大学において実施された臨床研究である「JIKEI HEART Study」及び京都府立医科大学において実施された臨床研究である「KYOTO HEART Study」の結果を記載した資材を用いて、同医薬品の効能又は効果に関して広告を行った。

Compliance context

High

The authority announced a criminal accusation or referral based on the disclosed facts.

Japanese regulatory disclosure under 薬事法.

Escalate for legal review and check whether later public records changed the status of the matter.

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: 2026-04-24T23:31:43.527+00:00
Evidence checked: 2026-04-24T23:31:43.527+00:00
Archive captured: 2026-04-04T06:00:43.976+00:00

Show audit JSON

{
  "record": {
    "id": "c6dd049c-afab-4bc2-9b85-802c589b86f2",
    "url": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20140109",
    "company_name_original": "ノバルティス　ファーマ株式会社",
    "company_name_registry": "ノバルティス　ファーマ株式会社",
    "corporate_number": "4010401011491",
    "law": {
      "ja": "薬事法",
      "en": "薬事法"
    },
    "action_type": {
      "ja": "告発",
      "en": "Criminal Accusation"
    },
    "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": "High",
    "actionMeaning": "The authority announced a criminal accusation or referral based on the disclosed facts.",
    "practicalNote": "Escalate for legal review and check whether later public records changed the status of the matter.",
    "lawContext": "Japanese regulatory disclosure under 薬事法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20140109",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000034241.html",
    "archiveUrl": "https://kiroku.today/view/db56d347f1jxbwk5",
    "archiveCapturedAt": "2026-04-04T06:00:43.976+00:00",
    "extractedAt": "2026-04-24T23:31:43.527+00:00",
    "translatedAt": "2026-05-01T06:48:30.886+00:00",
    "evidenceCheckedAt": "2026-04-24T23:31:43.527+00:00",
    "generatedAt": "2026-06-21T11:53:29.754Z"
  },
  "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: ノバルティス　ファーマ株式会社 Japanese original
Japanese name: ノバルティス　ファーマ株式会社
Corporate Number: 4010401011491
Registered address: 東京都港区虎ノ門１丁目２３番１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.

Criminal Accusation against ノバルティス ファーマ株式会社