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PMDA’s Efforts to Combat COVID-19

PMDA’s Efforts to Combat COVID-19

Approved Medical Products for COVID-19

 The following products were approved for COVID-19 by the Ministry of Health, Labour and Welfare after March 2020 with prior scientific review by the PMDA.
 For information of products under review by the PMDA or development by sponsors, please contact sponsors or developers of the product.

Drugs

Active Ingredient Brand Name Applicant Company Approval Date
Remdesivir VEKLURY for Intravenous Injection Gilead Sciences K.K. May 7, 2020
(approved based on article 14-3 of the PMD Act)

 

Medical Devices

Japanese
Medical Device
Nomenclature
(JMDN)
Brand Name Applicant Company Approval Date
Ventilator for general purpose NKV-550 Series Ventilator System NIHON KOHDEN CORPORATION April 24, 2020
Bi-level positive airway pressure unit Philips Respironics E30 ventilator Philips Japan, Ltd. May 1, 2020
Adult ventilator Philips Trilogy Evo Series Philips Japan, Ltd. May 12, 2020

 

In Vitro Diagnostics

Japanese
Medical Device
Nomenclature
(JMDN)
Brand Name Applicant Company Approval Date Other Information
SARS-CoV-2 nucleic acid kit 2019-nCoV Fluorescence Detection Real-time RT-PCR Kitv Sysmex Corporation March 27, 2020  
SARS-CoV-2 nucleic acid kit Loopamp Novel Coronavirus 2019 (SARS-CoV-2) Detection Kit Eiken Chemical Co., Ltd. March 31, 2020  
SARS-CoV-2 nucleic acid kit cobas SARS-CoV-2 Roche Diagnostics K.K. April 7, 2020  
SARS-CoV-2 nucleic acid kit TaqPath Real Time PCR Reagent Kit for SARS-CoV-2 Life Technologies Japan Ltd. April 20, 2020  
SARS-CoV-2 nucleic acid kit Xpert® Xpress SARS-CoV-2 ‘Cepheid’ Beckman Coulter, Inc. May 8, 2020  
SARS-CoV-2 antigen kit ESPLINE SARS-CoV-2 Fujirebio Inc. May 13, 2020 Review Summary
SARS-CoV-2 nucleic acid kit MEBRIGHT SARS-CoV-2 Kit Medical & Biological Laboratories Co., Ltd. May 21, 2020  

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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PMDA’s Efforts to Combat COVID-19
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