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大日本住友製薬 株式会社

大日本住友製薬 株式会社

大日本住友製薬株式会社は、日本に本拠を置く製薬企業である。2020年4月時点で薬機法に関する処分が1件、薬事法に関する処分が2件記録されている。

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 6 years ago

27 Apr 2020

Total penalties
-

Repeated actions: 5 actions are recorded for this company. Multiple actions under the same law may be relevant when reviewing repeat compliance issues.

Enforcement and administrative action history

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance
Possible entity match

Product names: (1) Metgluco Tablets 250 mg (2) Metgluco Tablets 500 mg

27 Apr 2020Ministry of Health, Labour and Welfare
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医薬品医療機器等法自主回収
RepeatPossible entity match

販売名：(1)メトグルコ錠２５０ｍｇ (2)メトグルコ錠５００ｍｇ

27 Apr 2020Ministry of Health, Labour and Welfare
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薬事法先駆け審査指定制度対象品目の募集
Possible entity match

Unapproved Parkinson's disease treatment using non-self iPS cell-derived dopamine neural precursor cells

5 Oct 2017Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices指定
RepeatPossible entity match

パーキンソン病に対するiPS細胞由来のドパミン神経前駆細胞を用いた治療。

28 Feb 2017Ministry of Health, Labour and Welfare
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薬事法指定
Possible entity match

This concerns Parkinson's disease treatment using non-autologous iPS cell-derived dopamine neural precursor cells, which have a different mechanism of action from conventional treatments. Although there is no clinical experience, non-clinical efficacy evaluations have reported significant symptom improvement (more than 40% in motor symptom scores) from six months after transplantation, as well as dopamine synthesis and reuptake activity (PET imaging) at the transplantation site in the brain.

28 Feb 2017Ministry of Health, Labour and Welfare
Open source archiveCheck original source

Language

日本語版を見る (Japanese)

Registry data

English name
大日本住友製薬 株式会社
Japanese name
大日本住友製薬 株式会社
Status
Active

Note: This company may not have detailed gBizINFO data, or RegBase has not completed enrichment yet. The public sources below may contain supplemental registry information.

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Data sources

Breakdown by law

Breakdown by action type

About this English name

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

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