{"data":[{"id":"127c21e1-ce0d-43db-a0d9-d0d41de1d7f1","company_name":"モデルナ・ジャパン株式会社","company_name_en":null,"corporate_number":"4010401159678","authority":"厚生労働省","law_name":"薬機法","action_type":"承認","action_date":"2023-09-12","announcement_date":"2026-04-10","violation_summary":"本日、以下のとおり、スパイクバックス筋注の一部変更について承認を行いました。なお、添付文書は別添のとおりです。","violation_summary_en":"Today, approval was granted for some changes to Spikevax intramuscular injection. The attached document is provided separately.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_35190.html","url":"https://regbase.jp/enforcement/yakkiho-moderunaziyapan-20230912"},{"id":"532f2e6a-a6e9-4564-9661-98101db9d765","company_name":"モデルナ・ジャパン株式会社","company_name_en":null,"corporate_number":"4010401159678","authority":"厚生労働省","law_name":"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":"行政指導","action_date":"2022-11-01","announcement_date":"2026-04-10","violation_summary":"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。","violation_summary_en":"Today, a special approval was granted for a partial change to the approval of Spikebacks intramuscular injection. The package insert is attached separately.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_28919.html","url":"https://regbase.jp/enforcement/other-moderunaziyapan-20221101"},{"id":"b7fb1b4a-8dec-4cc8-811a-b92e319ac03e","company_name":"モデルナ・ジャパン株式会社","company_name_en":null,"corporate_number":"4010401159678","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2022-11-01","announcement_date":"2026-05-04","violation_summary":"新型コロナウイルスワクチンの特例承認について","violation_summary_en":null,"penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_28919.html","url":"https://regbase.jp/enforcement/yakkiho-moderunaziyapan-20221101"},{"id":"f23c0591-9465-44c7-bdff-e5b7462bdf59","company_name":"モデルナ・ジャパン株式会社","company_name_en":null,"corporate_number":"4010401159678","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"承認","action_date":"2022-09-12","announcement_date":"2026-04-09","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_27929.html","url":"https://regbase.jp/enforcement/other-moderunaziyapan-20220912"},{"id":"5c8b913b-50e6-479a-b8ae-27d05b0dfbe2","company_name":"モデルナ・ジャパン株式会社","company_name_en":null,"corporate_number":"4010401159678","authority":"厚生労働省","law_name":"薬機法","action_type":"承認","action_date":"2022-09-12","announcement_date":"2026-04-28","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_27929.html","url":"https://regbase.jp/enforcement/yakkiho-moderunaziyapan-20220912"}],"meta":{"query":null,"corporate_number":"4010401159678","law":null,"authority":null,"action_type":null,"count":5,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":9,"reset_at":"2026-05-30T22:47:04.906Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":209,"reset_at":"2026-05-31T22:46:04.906Z"}}}