Business Improvement Order against Nobaruteisu Huama K.K.
Action summary
- Company
- Nobaruteisu Huama K.K.RomanizedOriginal: ノバルティスファーマ株式会社Corporate Number: 4010401011491
- Governing law
- 医薬品医療機器法医薬品医療機器法
- Action type
- Business Improvement Order業務改善命令
- Action date
- November 13, 2015
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Due to a malfunction in the adverse reaction reporting system, violations of reporting obligations for adverse reactions involving 57 prescription drugs containing 57 ingredients manufactured and sold by the company were identified, with 5,475 cases. Additionally, due to the same cause, there were violations involving 28 ingredients' clinical trial drugs, with 154 cases of adverse reactions.
Show original Japanese text
副作用システムの障害により、57成分の第一種医薬品の副作用報告義務違反と、同じ原因により発生した28成分の治験の被験薬に関する154症例の副作用報告義務違反
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- Nobaruteisu Huama K.K. Romanized
- Japanese name
- ノバルティス ファーマ株式会社
- Corporate Number
- 4010401011491
- Registered address
- 東京都港区虎ノ門１丁目２３番１号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.