Administrative Guidance against モデルナ・ジャパン株式会社
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/api/v1/enforcements?corporate_number=4010401159678&limit=10Action summary
- Company
- モデルナ・ジャパン株式会社Japanese originalOriginal: モデルナ・ジャパン株式会社Corporate Number: 4010401159678
- 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
- 新型コロナウイルス感染症の予防に関する特例承認新型コロナウイルス感染症の予防に関する特例承認
- Action type
- Administrative Guidance行政指導
- Action date
- 1 November 2022
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Today, a special approval was granted for a partial change to the approval of Spikebacks intramuscular injection. The package insert is attached separately.
Show original Japanese text
本日、以下のとおり、スパイクバックス筋注の承認事項一部変更について、特例承認を行いました。なお、添付文書は別添のとおりです。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 新型コロナウイルス感染症の予防に関する特例承認.
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
- 2026-04-25T00:21:06.955+00:00
- Evidence checked
- 2026-04-25T00:21:06.955+00:00
- Archive captured
- 2026-04-10T00:01:55.953+00:00
Show audit JSON
{
"record": {
"id": "532f2e6a-a6e9-4564-9661-98101db9d765",
"url": "https://regbase.jp/en/enforcement/other-moderunaziyapan-20221101",
"company_name_original": "モデルナ・ジャパン株式会社",
"company_name_registry": "モデルナ・ジャパン株式会社",
"corporate_number": "4010401159678",
"law": {
"ja": "新型コロナウイルス感染症の予防に関する特例承認",
"en": "新型コロナウイルス感染症の予防に関する特例承認"
},
"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 新型コロナウイルス感染症の予防に関する特例承認."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-moderunaziyapan-20221101",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28919.html",
"archiveUrl": "https://kiroku.today/view/b65dc91e50s55lf7",
"archiveCapturedAt": "2026-04-10T00:01:55.953+00:00",
"extractedAt": "2026-04-25T00:21:06.955+00:00",
"translatedAt": "2026-05-01T07:09:31.859+00:00",
"evidenceCheckedAt": "2026-04-25T00:21:06.955+00:00",
"generatedAt": "2026-06-28T16:49:27.322Z"
},
"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
- モデルナ・ジャパン株式会社 Japanese original
- Japanese name
- モデルナ・ジャパン株式会社
- Corporate Number
- 4010401159678
- Registered address
- 東京都港区虎ノ門4丁目1番1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.