Enforcement record

特例承認 disclosure naming ファイザー株式会社

ファイザー株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure10 February 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

10 February 2022

Current page: Enforcement record

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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, 04:21 PM JST

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Action summary

Company: ファイザー株式会社Japanese only
Original: ファイザー株式会社
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: 10 February 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 treatment drug for COVID-19: Paxlovid Pack, Generic name: Nirmatrelvir, Ritonavir, Applicant: Pfizer Inc., Application date: January 14, 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：パキロビッドパック、一般名：ニルマトレルビル、リトナビル、申請者：ファイザー株式会社、申請日：令和４年１月14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.