Enforcement record
Administrative Guidance disclosure naming モデルナ・ジャパン株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
新型コロナウイルス感染症の予防に関する特例承認
Authority
Ministry of Health, Labour and Welfare
Action date
1 November 2022
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
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, 04:22 PM JST
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Action summary
- Company
- モデルナ・ジャパン株式会社Japanese onlyOriginal: モデルナ・ジャパン株式会社
- 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.
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.