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
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
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Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Jul 12, 2026, 04:20 PM JST
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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.
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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.