Enforcement record

特例承認 disclosure naming アストラゼネカ株式会社

アストラゼネカ株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure30 August 2022

Action type

特例承認

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

30 August 2022

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority
Ministry of Health, Labour and Welfare
Official source URL
Recorded by RegBase
Entity match
Not confirmed; shown under the published name
Kiroku preservation
Queued for preservation
Captured: Jul 12, 2026, 04:20 PM JST

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Action summary

Company
アストラゼネカ株式会社Japanese only
Original: アストラゼネカ株式会社
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
医薬品医療機器等法
Action type
特例承認
特例承認
Action date
30 August 2022
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医薬品

Violation

Machine-translated summary — verify against original

Name of the COVID-19 treatment drug: Evashield Intramuscular Injection Set, Generic names: Tixagevimab (Genetically Modified) and Cilgavimab (Genetically Modified), Applicant: AstraZeneca K.K., Application date: June 9, 2022 (Reiwa 4).

Show original Japanese text

新型コロナウイルス感染症に係る治療薬の販売名：エバシェルド筋注セット、一般名：チキサゲビマブ（遺伝子組換え）及びシルガビマブ（遺伝子組換え）、申請者：アストラゼネカ株式会社、申請日：令和４年６月９日

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

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Language

日本語版を見る (Japanese)

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.