Enforcement record
Administrative Guidance disclosure naming ヤンセンファーマ株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
17 April 2014
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-OTHER-YANSENHUAMA-202607270753
- Generated at
- 27 July 2026 at 16:53
- Record URL
- https://regbase.jp/en/enforcement/other-yansenhuama-20140417
1. Review Summary
| Disclosure name | ヤンセンファーマ株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 17 April 2014 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | Administrative Guidance |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | ヤンセンファーマ株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | ヤンセンファーマ株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / Administrative Guidance |
| Action / announcement date | Action: 17 April 2014 / Announcement: 6 May 2026 |
| English summary | On April 17, 2014, the Ministry of Health, Labour and Welfare issued administrative guidance to Janssen Pharma Co., Ltd., a pharmaceutical manufacturer and distributor, concerning the schizophrenia treatment drug Zepreon (Zepreon water suspension injection). This action was taken after reports of multiple deaths among patients using the drug, with an unclear causal relationship. The guidance required the company to revise the 'Precautions for Use' section of the product's package insert and to promptly notify healthcare professionals through a safety bulletin (Blue Letter) to ensure proper use and awareness of safety concerns. |
| 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 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000043861.html |
| Source archive | https://kiroku.today/a/2bab1a77aftam3jo |
| Extraction / evidence timestamps | Extracted: 6 May 2026 at 09:02 / Evidence checked: 6 May 2026 at 09:02 / Archive captured: 6 May 2026 at 09:02 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
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Preserved evidence by Kiroku
Review the preserved source for ヤンセンファーマ株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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Action summary
- Company
- ヤンセンファーマ株式会社Japanese onlyOriginal: ヤンセンファーマ株式会社
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices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
- Industry context
- 医薬品製造販売
Violation
On April 17, 2014, the Ministry of Health, Labour and Welfare issued administrative guidance to Janssen Pharma Co., Ltd., a pharmaceutical manufacturer and distributor, concerning the schizophrenia treatment drug Zepreon (Zepreon water suspension injection). This action was taken after reports of multiple deaths among patients using the drug, with an unclear causal relationship. The guidance required the company to revise the 'Precautions for Use' section of the product's package insert and to promptly notify healthcare professionals through a safety bulletin (Blue Letter) to ensure proper use and awareness of safety concerns.
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-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
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
- 2026-05-06T00:02:11.855+00:00
- Evidence checked
- 2026-05-06T00:02:11.855+00:00
- Archive captured
- 2026-05-06T00:02:22.982994+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": null,
"corporate_number": null,
"law": {
"ja": "医薬品医療機器等法",
"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": "unresolved",
"confidence": 85,
"method": "nta_strict_name_nationally_unique",
"method_label": "nta_strict_name_nationally_unique",
"notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (ヤンセンファーマ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"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 Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-yansenhuama-20140417",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/2bab1a77aftam3jo",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
"archiveCapturedAt": "2026-05-06T00:02:22.982994+00:00",
"extractedAt": "2026-05-06T00:02:11.855+00:00",
"translatedAt": "2026-07-06T07:42:00.04+00:00",
"evidenceCheckedAt": "2026-05-06T00:02:11.855+00:00",
"generatedAt": "2026-07-27T07:53:43.974Z"
},
"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)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.