{"data":[{"id":"371c6188-28ee-493e-a1c9-80ae1527af43","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"特例承認","action_date":"2021-12-16","announcement_date":"2026-04-27","violation_summary":"新型コロナウイルス感染症に係るワクチンの製造販売承認事項の一部変更について、医薬品医療機器等法第14条の３に基づく特例承認を行いました。","violation_summary_en":"A special approval was granted under Article 14-3 of the Pharmaceuticals and Medical Devices Act for a partial change to the manufacturing and marketing approval of the COVID-19 vaccine.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_22838.html","url":"https://regbase.jp/enforcement/other-wu-tian-yao-pin-gong-ye-20211216"},{"id":"fc5ed706-7a79-4e30-865d-96ab94d3c494","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2021-09-02","announcement_date":"2026-04-26","violation_summary":"新型コロナウイルスワクチン（販売名：COVID-19 ワクチンモデルナ筋注）の使用見合わせロットにおける異物混入に関する調査結果について報告がありましたので、お知らせいたします。","violation_summary_en":"A report has been received regarding the investigation results of foreign matter contamination in the batch of the COVID-19 Vaccine Moderna Intramuscular Injection, which was withheld from use.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20855.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210902"},{"id":"6e6b1d64-21dc-4e6d-8e5f-71a3c0030ceb","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2021-09-01","announcement_date":"2026-04-08","violation_summary":"調査結果によると、バイアルに混入した異物は、これまでに複数のロットでごくまれに発見されている製品のゴム栓様の異物である可能性が高いと考えられ、同一ロットの他のバイアルについては有効性及び安全性に問題はなく、当該ロットのワクチンの接種を差し控える必要はないと考えられます。","violation_summary_en":"According to investigation results, the foreign substance mixed into the vials is highly likely to be rubber stopper-like debris that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and vaccination with the vaccine from this lot is not deemed necessary to be withheld.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20847.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210901"},{"id":"6f2006e5-9e70-4221-b90d-f623d9998d05","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2021-08-30","announcement_date":"2026-04-08","violation_summary":"調査結果によると、バイアルに混入した異物は、これまでに複数のロットでごくまれに発見されている製品のゴム栓様の異物である可能性が高いと考えられ、同一ロットの他のバイアルについては有効性及び安全性に問題はなく、当該ロットのワクチンの接種を差し控える必要はないと考えられます。","violation_summary_en":"According to investigation results, the foreign substance mixed into the vials is highly likely to be a rubber stopper-like foreign object that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and it is believed that vaccination with the vaccine from this lot does not need to be withheld.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20768.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210830"},{"id":"3ea64bdf-2c7d-4fb8-9188-fd0ea331c868","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2021-08-29","announcement_date":"2026-04-08","violation_summary":"調査結果によると、異物が発見されたバイアルは、いずれも穿刺前には異物が混入していなかったことが確認されており、穿刺時のコアリング等により異物が混入した可能性が高いため、当該ロットのワクチンの品質に問題は無いと考えられる。","violation_summary_en":"According to the investigation, vials with foreign objects were confirmed not to have had foreign objects before puncture. It is highly likely that the foreign objects were introduced during puncture, such as through coring, and therefore there is no issue with the quality of the vaccine from this lot.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20760.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210829"},{"id":"01c6f7d6-18ce-4194-a3da-6492152a9f3d","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"措置命令","action_date":"2021-08-26","announcement_date":"2026-04-08","violation_summary":"新型コロナウイルスワクチン（販売名：COVID-19 ワクチンモデルナ筋注）の一部ロットについて、使用を見合わせるようワクチン接種施設への情報提供を開始した旨の報告がありましたので、お知らせいたします。...当該ワクチンについては、特定のロットについて、未使用の状態での異物の混入が複数の接種施設より報告されたことを踏まえ、武田薬品工業との協議の結果、当面の安全対策措置として、異物混入のリスクが否定できない下記の対象ロットの使用を見合わせることとしたものです。","violation_summary_en":"A report has been received that certain lots of the COVID-19 Vaccine Moderna Intramuscular Injection (brand name: COVID-19 ワクチンモデルナ筋注) are being withheld from use. Multiple vaccination facilities reported foreign matter contamination in unused vaccine from specific lots. As a safety measure, in consultation with Takeda Pharmaceutical Company, the use of the following lots, where the risk of foreign matter contamination cannot be ruled out, has been suspended.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20693.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210826"},{"id":"256eb41b-8486-430f-a946-ae6b45793176","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"使用見合わせ","action_date":"2021-08-26","announcement_date":"2026-04-26","violation_summary":"新型コロナウイルスワクチン（販売名：COVID-19 ワクチンモデルナ筋注）の一部ロットについて、未使用の状態での異物の混入が複数の接種施設より報告されたことを踏まえ、武田薬品工業との協議の結果、当面の安全対策措置として、異物混入のリスクが否定できない下記の対象ロットの使用を見合わせることとしたものです。","violation_summary_en":"Regarding certain lots of the COVID-19 Vaccine Moderna Intramuscular Injection (brand name: COVID-19 ワクチンモデルナ筋注), reports from multiple vaccination facilities indicated the presence of foreign substances in unused vaccines. After discussions with Takeda Pharmaceutical Company, as a safety measure, the use of the following lots, where the risk of foreign substance contamination cannot be ruled out, has been suspended.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_20693.html","url":"https://regbase.jp/enforcement/other-wu-tian-yao-pin-gong-ye-20210826"},{"id":"de3f0837-43b6-4dde-9437-2fa8af012369","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"特例承認","action_date":"2021-05-21","announcement_date":"2026-04-08","violation_summary":"医薬品医療機器等法に基づく新型コロナウイルスワクチンの特例承認を行いました。","violation_summary_en":"A special approval for the novel coronavirus vaccine was granted under the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_18787.html","url":"https://regbase.jp/enforcement/other-wu-tian-yao-pin-gong-ye-20210521"},{"id":"d487e262-d669-45d4-b923-013c04c068a7","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"注意喚起","action_date":"2015-02-04","announcement_date":"2026-04-04","violation_summary":"厚生労働省は、本日、抗てんかん薬、双極性障害治療薬「ラミクタール錠」（別添１）について、重篤な皮膚障害が発現し死亡に至った症例が報告されていることを踏まえ、添付文書の「使用上の注意」を改訂するとともに、「安全性速報（ブルーレター）」（別添２）により、医療関係者等に対して速やかに注意喚起を行うよう、製造販売業者に指示しました。","violation_summary_en":"The Ministry of Health, Labour and Welfare has revised the 'Precautions for Use' section of the package insert for the antiepileptic and bipolar disorder medication 'Lamictal Tablets' (attached document 1), based on reports of severe skin disorders leading to death. Additionally, it instructed manufacturers and marketers to promptly alert healthcare professionals through a 'Safety Information (Blue Letter)' (attached document 2).","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000073061.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20150204"},{"id":"cbcd07a1-16ca-4620-8649-a395533bd354","company_name":"武田薬品工業株式会社","company_name_en":null,"corporate_number":"2120001077461","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2014-10-24","announcement_date":"2026-04-30","violation_summary":"厚生労働省は、本日、C型慢性肝炎治療薬「ソブリアードカプセル100mg」（別添１）について、高ビリルビン血症に関連した死亡例が報告されていることを踏まえ、添付文書の「使用上の注意」を改訂するとともに、「安全性速報（ブルーレター）」（別添２）により、医療関係者等に対して速やかに注意喚起を行うよう、製造販売業者に指示しました。","violation_summary_en":"The Ministry of Health, Labour and Welfare has revised the 'Precautions for Use' section of the package insert for the hepatitis C treatment drug 'Sovriad Capsules 100mg' (Attachment 1) based on reports of deaths associated with hyperbilirubinemia. Additionally, they have instructed the manufacturer to promptly issue a safety alert (Blue Letter) (Attachment 2) to healthcare professionals to raise awareness.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000062032.html","url":"https://regbase.jp/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20141024"}],"meta":{"query":null,"corporate_number":"2120001077461","law":null,"authority":null,"action_type":null,"count":10,"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":3,"reset_at":"2026-05-21T05:39:07.711Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":264,"reset_at":"2026-05-22T05:38:07.711Z"}}}