What's New (Post-marketing Safety Measures)

September 6, 2024

Safety

New

PMDA Risk Communication: Aspirin (preparations indicated for antipyresis and analgesia), etc. posted

August 28, 2024

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.412 posted

August 27, 2024

Safety

Revisions of PRECAUTIONS: Sodium valproate, etc. posted

June 20, 2024

Safety

Notifications Related to Safety Measures (Drugs): ”Amendment of the Instructions for Electronic Package Inserts Regarding Results of Studies Using Medical Information Database” and “Points to Consider for Describing the Results of Studies Using Medical Information Database in Electronic Package Inserts” posted

May 7, 2024

Safety

PMDA Alert for Proper Use of Drugs: Dependence Associated with Benzodiazepine Receptor Agonists, revised and posted

April 10, 2024

Safety

Notifications Related to Safety Measures (medical devices): Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. (Part 2) posted

March 28, 2024

Safety

Revisions of PRECAUTIONS (Regenerative Medical Products): Axicabtagene ciloleucel, etc. posted

March 28, 2024

Safety

Revisions of PRECAUTIONS: Andexanet alfa (genetical recombination) posted

March 14, 2024

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.408

March 1, 2024

Safety

PMDA Risk Communication: Axicabtagene ciloleucel, etc. posted

February 29, 2024

Safety

Notifications Related to Safety Measures (in vitro diagnostics) : Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. posted

February 29, 2024

Safety

Notifications Related to Safety Measures (Regenerative Medical Products): Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. posted

February 15, 2024

Safety

PMDA Medical Safety Information: Precautions for Blood Purification in Patients Receiving ACE Inhibitors（No.68）posted

December 27, 2023

Safety

English Translated Package Inserts page: Ensure Liquid updated

March 27, 2023

Safety

Revisions of PRECAUTIONS:Anti-human thymocyte immunoglobulin, rabbit posted

March 14, 2023

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.399

July 29, 2022

Safety

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

March 23, 2022

Safety

Revisions of PRECAUTIONS: Ticagrelor, etc. posted

March 11, 2022

Safety

PMDA Alert for Proper Use of Medical Devices: Bleeding Caused by the Use of IMPELLA Circulatory Assistance Pump Catheter, posted

March 8, 2022

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.390

December 24, 2021

Safety

Revisions of PRECAUTIONS (Medical Devices): Power Morcellators posted

November 29, 2021

Safety

Provision of Information regarding Post-marketing Safety updated

November 29, 2021

Safety

Information regarding Newly Introduced Electronic Package Inserts posted

June 1, 2021

Safety

Urgent Safety Information (the blue letter) Joyclu, has been posted.

March 30, 2021

Safety

Revisions of PRECAUTIONS (Cellular and Tissue-based Products): Onasemnogene abeparvovec, posted

March 30, 2021

Safety

Revisions of PRECAUTIONS: Magnesium sulfate hydrate/glucose, etc. posted

March 23, 2021

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.381

February 18, 2021

Safety

Notification on self-check, posted

February 18, 2021

Safety

PMDA Risk Communication (Medical devices Risk Information of ongoing evaluation) :Drug-eluting coronary stent, etc. posted

July 10, 2020

Safety

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

Safety

Revisions of PRECAUTIONS:Spiperone, etc. posted

March 24, 2020

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.371

March 28, 2019

Safety

Revisions of PRECAUTIONS:Amobarbital, etc. posted

March 12, 2019

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.361

March 30, 2018

Safety

Link to English translated Regulatory Notices related to Connectors for Prevention of Interconnection was posted

March 27, 2018

Safety

Revisions of PRECAUTIONS: Adrenaline, etc. posted

March 14, 2018

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.351

March 21, 2017

Safety

Revisions of PRECAUTIONS: Lamotrigine, etc. posted

April 18, 2016

Safety

Investigation results: Mycophenolate Mofetil posted

March 24, 2016

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.331

June 30, 2015

Safety

Notification on self-check：Electric massage devices for home use

May 19, 2015

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.321

April 8, 2015

Safety

Revisions of PRECAUTIONS (Summary of investigation results): cetuximab and panitumumab posted