MHLW Pharmaceuticals and Medical Devices Safety Information (FY2025)

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**FY 2025 (No.418-)**
Issue	No.	Table of contents
November 2025	424	Full text [716KB] Article 1-1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation for the System Article 1-2. Relief Efforts for Human Papilloma Virus Vaccine Through the Relief System for Adverse Drug Reactions Article 2. Fire Accidents Involving Patients during Use of Long-term Oxygen Therapy Article 3. Provision of Information on Use of Antipyretic Analgesic During Pregnancy Article 4. Important Safety Information Article 4.-1 Lubiprostone Article 5. Revisions of PRECAUTIONS (No.364) Article 5.-1 Lubiprostone (and 3 others) Article 6. List of Products Subject to Early Post-marketing Phase Vigilance
Octover 2025	423	Full text [427 KB] Article 1. Suspected Adverse Reactions to Influenza Vaccines in the 2024 Season Article 2. Important Safety Information Article 2.-1 Telmisartan Article 2.-2 Perindopril erbumine Article 2.-3 Mesalazine Article 2.-4 Nivolumab (genetical recombination) Article 3. Revisions of PRECAUTIONS (No.363) Article 3.-1 Delandistrogene moxeparvovec (and 18 others) Article 4. List of Products Subject to Early Post-marketing Phase Vigilance
August 2025	422	Full text [443 KB] Article 1. Utilization of Risk Management Plan (RMP) Article 2. Important Safety Information Article 2.-1 Semaglutide (genetical recombination) Article 2.-2 Tirzepatide Article 2.-3 Afatinib maleate Article 2.-4 Fulvestrant Article 2.-5 Sunitinib malate Article 2.-6 Pembrolizumab (genetical recombination) Article 3. Revisions of PRECAUTIONS (No.362) Article 3.-1 [1] Semaglutide (genetical recombination),[2] Tirzepatide,[3] Insulin glargine (genetical recombination)/lixisenatide (and 4 others) Article 4. List of Products Subject to Early Post-marketing Phase Vigilance
July 2025	421	Full text [676 KB] Article 1. Mandatory Registration of Pharmaceuticals, Medical Devices, etc. in a Product Database, and Utilization of Barcodes . Article 2. Important Safety Information Article 2.-1 Thiamazole Article 3. Revisions of PRECAUTIONS (No.361) Article 3.-1 Desmopressin acetate hydrate (oral dosage form) (and 2 others) Article 4. List of Products Subject to Early Post-marketing Phase Vigilance
June 2025	420	Full text [667 KB] Article 1. Revision of PRECAUTIONS for Domperidone Article 2. Revisions of PRECAUTIONS for Iodixanol Article 3. Important Safety Information Article 3.-1 Nemolizumab (genetical recombination) Article 3.-2 Iodixanol Article 3.-3 Indapamide Article 3.-4 Indapamide Article 4. Revisions of PRECAUTIONS (No.360) Article 4.-1 [1] Acetazolamide, [2] Acetazolamide sodium (and 20 others) Article 5. List of Products Subject to Early Post-marketing Phase Vigilance
May 2025	419	Full text [507 KB] Article 1. The Manuals for Management of Individual Serious Adverse Drug Reactions Article 2. Revisions of PRECAUTIONS (No.359) Article 2.-1 Desmopressin acetate hydrate (and 3 others) Article 3. List of Products Subject to Early Post-marketing Phase Vigilance
April 2025	418	Full text [684 KB] Article 1. Efforts Against Abuse of Over-the-Counter Drugs Article 2. Important Safety Information Article 2.-1 Dulaglutide (genetical recombination) Article 3. Revisions of PRECAUTIONS (No.358) Article 3.-1 Dulaglutide (genetical recombination) (and 4 others) Article 4. List of Products Subject to Early Post-marketing Phase Vigilance