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ヤンセンファーマ株式会社

ヤンセンファーマ株式会社· Corporate Number: 4010001089128

ヤンセンファーマ株式会社は、東京都千代田区西神田に本店を置く企業である。薬事法（薬機法）に関して2014年4月17日に1件の行政処分を受けている。

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 12 years ago

17 Apr 2014

Total penalties
-

Enforcement and administrative action history

医薬品医療機器等法Administrative Guidance
RepeatConfirmed entity match

添付文書の「使用上の注意」の改訂と、「安全性速報（ブルーレター）」により医療関係者等に注意喚起を行うこと

17 Apr 2014Ministry of Health, Labour and Welfare
Open source archiveCheck original source
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance
Confirmed entity match

The Ministry of Health, Labour and Welfare has instructed the manufacturer (Janssen Pharmaceutical K.K.) to revise the 'Precautions for Use' in the package insert and to promptly notify healthcare professionals via a safety bulletin (Blue Letter), based on reports of multiple deaths among patients using the schizophrenia treatment drug Zeprion Water Suspension, even though the causal relationship is unknown.

17 Apr 2014Ministry of Health, Labour and Welfare
Open source archiveCheck original source

Language

日本語版を見る (Japanese)

Registry data

English name
ヤンセンファーマ株式会社
Japanese name
ヤンセンファーマ株式会社
Corporate Number
4010001089128
Registered address
東京都千代田区西神田３丁目５番２号
Status
Active

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Data sources

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About this English name

No official English name source is recorded. The original Japanese name is shown.

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ヤンセンファーマ株式会社 Japanese Enforcement Records and Compliance Profile | RegBase