承認 against 中外製薬株式会社

中外製薬株式会社 (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 match21 January 2022
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/api/v1/enforcements?corporate_number=5011501002900&limit=10

Action summary

Company
中外製薬株式会社Japanese original
Original: 中外製薬株式会社
Corporate Number: 5011501002900
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
承認
承認
Action date
21 January 2022
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Approval for the addition of indications and effects related to COVID-19 for the pharmaceutical product Actemra intravenous infusion.

Show original Japanese text

医薬品アクテムラ点滴静注用の新型コロナウイルス感染症に関する効能・効果の追加承認

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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
2026-04-27T12:00:31.818+00:00
Evidence checked
2026-04-27T12:00:31.818+00:00
Archive captured
2026-04-27T12:00:32.547+00:00
Show audit JSON
{
  "record": {
    "id": "784daf35-8b72-434a-922b-7ba47dcf9ba3",
    "url": "https://regbase.jp/en/enforcement/yakkiho-zhong-wai-zhi-yao-20220121",
    "company_name_original": "中外製薬株式会社",
    "company_name_registry": "中外製薬株式会社",
    "corporate_number": "5011501002900",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "承認",
      "en": "承認"
    },
    "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": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-zhong-wai-zhi-yao-20220121",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_23497.html",
    "archiveUrl": "https://kiroku.today/view/960cf6000ah5b7oc",
    "archiveCapturedAt": "2026-04-27T12:00:32.547+00:00",
    "extractedAt": "2026-04-27T12:00:31.818+00:00",
    "translatedAt": "2026-05-01T09:42:51.128+00:00",
    "evidenceCheckedAt": "2026-04-27T12:00:31.818+00:00",
    "generatedAt": "2026-06-19T10:43:08.305Z"
  },
  "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
中外製薬株式会社 Japanese original
Japanese name
中外製薬株式会社
Corporate Number
5011501002900
Registered address
東京都北区浮間5丁目5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.