MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021)

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**FY 2021 (No.382-)**
Japanese version issued on	No.	Table of contents	PDF
March 8, 2022	390	Revision of Precautions for Aminolevulinic Acid Hydrochloride Revision of Precautions (No. 330) Aminolevulinic acid hydrochloride (and 1 other) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [182 KB]
January 18, 2022	389	How to Start and Proceed with Improving Polypharmacy among the Elderly in Hospitals Important Safety Information Fingolimod hydrochloride Revision of Precautions (No. 329) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 11 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [312 KB]
December 14, 2021	388	Suspected Adverse Reactions to Influenza Vaccines in the 2020 Season Important Safety Information Atezolizumab (genetical recombination) Revision of Precautions (No. 328) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [269 KB]
November 9, 2021	387	Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System Acute coronary syndrome accompanying allergic reaction (Kounis Syndrome) Important Safety Information Cefoperazone sodium/sulbactam sodium Revision of Precautions (No. 327) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 5 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [477 KB]
October 5, 2021	386	Precautions for Shock, Anaphylaxis in Patients Who Received Joyclu 30mg intra-articular injection to Improve Joint Function Revision of Precautions (No. 326) COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [245 KB]
August 20, 2021	385	Revision of Proper Control Procedures for Revlimid/Pomalyst (RevMate) Important Safety Information [1] Magnesium sulfate hydrate/glucose [2] Magnesium sulfate hydrate Revision of Precautions (No. 325) Nivolumab (genetical recombination) (and 9 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [476 KB]
July 13, 2021	384	Blood Monitoring and Rechallenge with Clozapine Important Safety Information Pembrolizumab (genetical recombination) Ixekizumab (genetical recombination) Revision of Precautions (No. 324) Diclofenac etalhyaluronate sodium (and 3 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [343 KB]
June 10, 2021	383	MID-NET (Medical Information Database NETwork) Revision of Precautions (No. 323) Shosaikotokakikyosekko List of Products Subject to Early Post-marketing Phase Vigilance	Full text [649 KB]
April 27, 2021	382	PI (Package insert)-navi: A Smartphone App Designed for Digitized Package Inserts Digitization of Reports from Medical Institutions on Adverse Drug Reactions and Post-vaccination Suspected Adverse Reactions Important Safety Information Ritodrine hydrochloride (injections) Durvalumab (genetical recombination) Onasemnogene abeparvovec Revision of Precautions (No. 322) Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) (and 8 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [1.9 MB]