Pmda - Pharmaceuticals and Medical Devices Agency

Jump to body

Navigation of each product type

Our recommended contents

Navigation of each product type

Our recommended contents

Home
Post-marketing Safety Measures
What's New (Post-marketing Safety Measures)

Here begins the text.

What's New (Post-marketing Safety Measures)

March 30, 2023 PMDA Medical Safety Informations: Precautions for Handling of Sustained-Release Preparations posted
March 27, 2023 Revisions of PRECAUTIONS:Anti-human thymocyte immunoglobulin, rabbit posted
March 14, 2023 MHLW Pharmaceuticals and Medical Devices Safety Information No.399
February 24, 2023 PMDA Risk Communication: Aluminoparaaminosalicylate calcium hydrate, etc. posted
February 9, 2023 Notifications Related to Safety Measures (In-vitro Diagnostics) : Consultation associated with Revision, etc. of Package Inserts, etc. for in vitro Diagnostics posted
February 8, 2023 Notifications Related to Safety Measures (Regenerative Medical Products) : Points to Consider, etc. for Reporting Clinical Trial Product Defects or Adverse Events, etc. relevant to Processed Cells, etc. posted
January 20, 2023 Notifications Related to Safety Measures (Medical Devices) : Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc. posted
January 20, 2023 Notifications Related to Safety Measures (Drugs): Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc. posted
October 7, 2022 PMDA Alert for Proper Use of Drugs: No.14 (Revised)
July 29, 2022 Risk Management Plan (RMP) ：RMP Page renewal, Questions and Answers (Qs and As) on Risk Management Plan, Risk Management Plan templates, instructions and publication posted
June 2, 2022 English Translated Package Inserts page now available. Gadoteridol posted.
March 23, 2022 Revisions of PRECAUTIONS: Ticagrelor, etc. posted
March 11, 2022 PMDA Alert for Proper Use of Medical Devices: Bleeding Caused by the Use of IMPELLA Circulatory Assistance Pump Catheter, posted
March 8, 2022 MHLW Pharmaceuticals and Medical Devices Safety Information No.390
December 24, 2021 Revisions of PRECAUTIONS (Medical Devices): Power Morcellators posted
November 29, 2021 Provision of Information regarding Post-marketing Safety updated
November 29, 2021 Information regarding Newly Introduced Electronic Package Inserts posted
June 1, 2021 Urgent Safety Information (the blue letter) Joyclu, has been posted.
March 30, 2021 Revisions of PRECAUTIONS (Cellular and Tissue-based Products): Onasemnogene abeparvovec, posted
March 30, 2021 Revisions of PRECAUTIONS: Magnesium sulfate hydrate/glucose, etc. posted
March 23, 2021 MHLW Pharmaceuticals and Medical Devices Safety Information No.381
February 18, 2021 Notification on self-check, posted
February 18, 2021 PMDA Risk Communication (Medical devices Risk Information of ongoing evaluation) :Drug-eluting coronary stent, etc. posted
July 10, 2020 PMDA Alert for Proper Use of Medical Devices (for patients): For patients who use a ventilator, etc. at home and their families or other caregivers, posted
March 31, 2020 Revisions of PRECAUTIONS:Spiperone, etc. posted
March 24, 2020 MHLW Pharmaceuticals and Medical Devices Safety Information No.371
March 28, 2019 Revisions of PRECAUTIONS:Amobarbital, etc. posted
March 12, 2019 MHLW Pharmaceuticals and Medical Devices Safety Information No.361
March 30, 2018 Link to English translated Regulatory Notices related to Connectors for Prevention of Interconnection was posted
March 27, 2018 Revisions of PRECAUTIONS: Adrenaline, etc. posted
March 14, 2018 MHLW Pharmaceuticals and Medical Devices Safety Information No.351
March 21, 2017 Revisions of PRECAUTIONS: Lamotrigine, etc. posted
April 18, 2016 Investigation results: Mycophenolate Mofetil posted
March 24, 2016 MHLW Pharmaceuticals and Medical Devices Safety Information No.331
June 30, 2015 Notification on self-check：Electric massage devices for home use
May 19, 2015 MHLW Pharmaceuticals and Medical Devices Safety Information No.321
April 8, 2015 Revisions of PRECAUTIONS (Summary of investigation results): cetuximab and panitumumab posted

Pmda - Pharmaceuticals and Medical Devices Agency

JCN 3010005007409

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