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Huaiza K.K.

ファイザー株式会社· Corporate Number: 5011001126167

ファイザー株式会社は東京都渋谷区代々木に本店を置く企業であり、詳細な設立年や資本金、従業員数などの情報は公開されていません。同社は薬機法に関する行政処分が2件、医薬品医療機器等法に関する処分が1件、2022年10月には新型コロナウイルスワクチンの特例承認に関する措置を受けています。

Public Record Summary

Actions in last 3 years
1records
Actions in last year
0records
Latest action
about 2 years ago

Sep 1, 2023

Total penalties
-

Repeated actions: 11 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 Devices一部変更承認

A monovalent vaccine containing mRNA encoding the spike protein of the Omicron XBB.1.5 lineage was added.

Sep 1, 2023Ministry of Health, Labour and Welfare
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新型コロナウイルスワクチンの特例承認についてCease and Desist Order

Regarding the special approval of the novel coronavirus vaccine

Oct 5, 2022Ministry of Health, Labour and Welfare
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医薬品医療機器等法承認

Approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.

Sep 12, 2022Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices承認

Approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.

Sep 12, 2022Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance

Applicant: Pfizer Inc.

Aug 30, 2022Ministry of Health, Labour and Welfare
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医薬品医療機器等法特例承認

Name of the treatment drug for COVID-19: Paxlovid Pack, Generic name: Nirmatrelvir, Ritonavir, Applicant: Pfizer Inc., Application date: January 14, 2022 (Reiwa 4).

Feb 10, 2022Ministry of Health, Labour and Welfare
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医薬品医療機器等法特例承認

A special approval was granted under Article 14-3 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices concerning a partial change to the manufacturing and marketing approval for the COVID-19 vaccine.

Jan 21, 2022Ministry of Health, Labour and Welfare
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医薬品医療機器等法特例承認
Repeat

A special approval was granted under Article 14-3 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices for partial changes to the manufacturing and marketing approval of COVID-19 vaccines.

Nov 11, 2021Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance

The formulation may contain white particles (floaters) derived from the product, but when diluted and dissolved, it can be used without issue. During dilution, gently invert the vial 10 times before and after dilution. Occasionally, even after dilution and gentle inversion, white particles derived from the product may remain undissolved. In such cases, do not use the vial with the residual particles and use another vial. The white particulate matter derived from the product is not associated with safety concerns. No extraneous foreign matter has been confirmed among the reported white particulate matter. Regarding the white particulate matter reported in multiple cases from different municipalities for lot number FF5357, investigations are ongoing. The results will be promptly announced and reported to the Ministry of Health, Labour and Welfare.

Sep 15, 2021Ministry of Health, Labour and Welfare
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医薬品医療機器等法特例承認
Repeat

The COVID-19 vaccine was granted special approval based on Article 14-3 of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.

Feb 14, 2021Ministry of Health, Labour and Welfare
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医薬品医療機器等法自主回収
Repeat

Product name: Ambaro Combination Tablets 'Pfizer'

Feb 8, 2019Ministry of Health, Labour and Welfare
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Language

日本語版を見る (Japanese)

Registry data

English name
Huaiza K.K.
Japanese name
ファイザー株式会社
Corporate Number
5011001126167
Registered address
東京都渋谷区代々木３丁目２２番７号
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.

View on gBizINFO ↗View on National Tax Agency Corporate Number site ↗

gBizINFO: fetched Apr 25, 2026

Data sources

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About this English name

Auto-romanized from the registered Japanese kana reading. Not an officially registered English name.

For sanctions screening or contractual purposes, always cross-reference using the Corporate Number (法人番号), not the English name alone.

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