Enforcement record
特例承認 disclosure naming グラクソ・スミスクライン株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
特例承認
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
27 September 2021
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-GURAKUSOSUM-202607260342
- Generated at
- 26 July 2026 at 12:42
- Record URL
- https://regbase.jp/en/enforcement/other-gurakusosumisukurain-20210927
1. Review Summary
| Disclosure name | グラクソ・スミスクライン株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 27 September 2021 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | 特例承認 |
| 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 | グラクソ・スミスクライン株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | グラクソ・スミスクライン株式会社 |
|---|---|
| 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 / 特例承認 |
| Action / announcement date | Action: 27 September 2021 / Announcement: 10 April 2026 |
| English summary | Name of the COVID-19 treatment drug: Zevudy intravenous infusion 500mg, Generic name: Sotrovimab (recombinant), Applicant: GlaxoSmithKline K.K., Application date: September 6, 2021. |
| Original Japanese text | 新型コロナウイルス感染症に係る治療薬の販売名:ゼビュディ点滴静注液500mg、一般名:ソトロビマブ(遺伝子組換え)、申請者:グラクソ・スミスクライン株式会社、申請日:令和3年9月6日 |
| Official source | https://www.mhlw.go.jp/stf/newpage_21273.html |
| Source archive | https://kiroku.today/a/25fb607d95hgrhry |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:20 / Evidence checked: 25 April 2026 at 09:20 / Archive captured: 12 July 2026 at 16:20 |
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
Save the disclosure record naming グラクソ・スミスクライン株式会社
Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.
Preserved evidence by Kiroku
Review the preserved source for グラクソ・スミスクライン株式会社
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
- グラクソ・スミスクライン株式会社Japanese onlyOriginal: グラクソ・スミスクライン株式会社
- 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
- 特例承認特例承認
- Action date
- 27 September 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品
Violation
Name of the COVID-19 treatment drug: Zevudy intravenous infusion 500mg, Generic name: Sotrovimab (recombinant), Applicant: GlaxoSmithKline K.K., Application date: September 6, 2021.
Show original Japanese text
新型コロナウイルス感染症に係る治療薬の販売名:ゼビュディ点滴静注液500mg、一般名:ソトロビマブ(遺伝子組換え)、申請者:グラクソ・スミスクライン株式会社、申請日:令和3年9月6日
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
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
- Extracted at
- 2026-04-25T00:20:23.402+00:00
- Evidence checked
- 2026-04-25T00:20:23.402+00:00
- Archive captured
- 2026-07-12T07:20:48.616121+00:00
Show audit JSON
{
"record": {
"id": "4cb2e776-2377-4d60-bff4-79eb3ffa97c1",
"url": "https://regbase.jp/en/enforcement/other-gurakusosumisukurain-20210927",
"company_name_original": "グラクソ・スミスクライン株式会社",
"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": "特例承認",
"en": "特例承認"
},
"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 (グラクソ・スミスクライン株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "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": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-gurakusosumisukurain-20210927",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21273.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/25fb607d95hgrhry",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21273.html",
"archiveCapturedAt": "2026-07-12T07:20:48.616121+00:00",
"extractedAt": "2026-04-25T00:20:23.402+00:00",
"translatedAt": "2026-05-01T07:08:44.984+00:00",
"evidenceCheckedAt": "2026-04-25T00:20:23.402+00:00",
"generatedAt": "2026-07-26T03:42:16.970Z"
},
"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.