MHLW Pharmaceuticals and Medical Devices Safety Information (FY2022)

日本語ページはこちら

**FY 2022 (No.391-399)**
Japanese version issued on	No.	Table of contents	PDF
March 14, 2023	399	Safety Control Measures for Generic Lenalidomide Preparations Important Safety Information Preparations containing GLP-1 receptor agonists and tirzepatide [1] Liraglutide (genetical recombination), [2] Exenatide, [3] Lixisenatide, [4] Dulaglutide (genetical recombination), [5] Semaglutide (genetical recombination), [6] Insulin degludec (genetical　recombination)/liraglutide (genetical recombination), [7] Insulin glargine (genetical recombination)/lixisenatide, [8] Tirzepatide Tazobactam/piperacillin hydrate Revision of Precautions (No. 339) Exenatide, semaglutide (genetical recombination), dulaglutide (genetical recombination), lixisenatide, liraglutide (genetical recombination), insulin glargine (genetical recombination)/lixisenatide, insulin degludec (genetical recombination)/liraglutide (genetical recombination) (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [482 KB]
February 14, 2023	398	Revisions of Precautions for 2 Calcium Channel Blockers (Amlodipine Besilate and Nifedipine) Revision of Precautions for Hydroxyethylated Starch Revision of the Package Insert for Hypothyroidism and Request for Adverse Drug Reaction Reports, etc. Important Safety Information Preparations containing acetaminophen Preparations containing clopidogrel sulfate Oral live attenuated human rotavirus vaccine Revision of Precautions (No. 338) Amlodipine besilate (and 16 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [519 KB]
December 14, 2022	397	Suspected Adverse Reactions to Influenza Vaccines in the 2021 Season Important Safety Information Roxadustat Preparations containing hydrochlorothiazide Imatinib mesilate Revision of Precautions (No. 337) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.1), Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5), Spikevax Intramuscular Injection (Bivalent: Original/Omicron BA.1)) (and 12 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [422 KB]
November 9, 2022	396	Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System Revisions of Precautions for Pemafibrate Important Safety Information Methotrexate Revision of Precautions (No. 336) Loxoprofen sodium hydrate (oral dosage form) (and 9 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [536 KB]
September 27, 2022	395	Revision of Precautions regarding the Co-administration of Riociguat with HIV Protease Inhibitors Important Safety Information Ramucirumab (genetical recombination) Revision of Precautions (No. 335) Hydroxychloroquine Sulfate (and 5 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [356 KB]
August 23, 2022	394	Genome Research on Drug-induced Interstitial Lung Disease Revision of Precautions for Zolpidem Tartrate, Zopiclone, Eszopiclone, Triazolam Important Safety Information Durvalumab (genetical recombination) Avelumab (genetical recombination) Revision of Precautions (No. 334) Recombinant COVID-19 (SARS-CoV-2) vaccine (Nuvaxovid Intramuscular Injection) (and 9 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [373 KB]
July 12, 2022	393	The Manuals for Management of Various Serious Adverse Drug Reactions Important Safety Information Cetuximab sarotalocan sodium (genetical recombination) Nirmatrelvir/ritonavir Molnupiravir Revision of Precautions (No. 333) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection, Comirnaty intramuscular injection for 5 to 11 years old, Spikevax Intramuscular Injection) (and 7 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [358 KB]
June 10, 2022	392	Revision of Precautions for Somatropin (genetical recombination) Revisions of Precautions for Interferon Beta-1a (genetical recombination) and Interferon Beta-1b (genetical recombination) New Project Development of the “Japan Drug Information Institute in Pregnancy” Important Safety Information [1] Dexamethasone (oral dosage form) (preparations indicated for pituitary suppression tests) (and 9 others) Revision of Precautions (No. 332) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 15 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [731 KB]
April 12, 2022	391	Revision of Precautions of Levonorgestrel (indicated for emergency contraception) Digitization of Reports from Medical Professionals on Adverse Reactions/Infections/Malfunctions and Suspected Adverse Reactions [Information on the Report Reception Site] Important Safety Information Nintedanib ethanesulfonate Revision of Precautions (No. 331) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [395 KB]